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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00379769




Registration number
NCT00379769
Ethics application status
Date submitted
21/09/2006
Date registered
22/09/2006

Titles & IDs
Public title
RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
Scientific title
A Long Term, Open Label, Randomised Study in Patients With Type 2 Diabetes, Comparing the Combination of Rosiglitazone and Either Metformin or Sulfonylurea With Metformin Plus Sulfonylurea on Cardiovascular Endpoints and Glycaemia
Secondary ID [1] 0 0
BRL-049653/231
Universal Trial Number (UTN)
Trial acronym
RECORD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosiglitazone
Treatment: Drugs - Sulfonylurea
Treatment: Drugs - Metformin

Experimental: rosiglitazone in addition to background metformin - Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Experimental: rosiglitazone in addition to background sulfonylurea - Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Active comparator: Sulfonylurea in addition to background metformin - Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.

Active comparator: Metformin in addition to background sulfonylurea - Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.


Treatment: Drugs: Rosiglitazone
Rosiglitazone maximum 8 mg per day

Treatment: Drugs: Sulfonylurea
Sulfonylurea (SU) maximum permitted daily dose

Treatment: Drugs: Metformin
Metformin maximum permitted daily dose .
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events
Assessment method [1] 0 0
The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.
Timepoint [1] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [2] 0 0
Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause
Assessment method [2] 0 0
All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.
Timepoint [2] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [3] 0 0
Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions
Assessment method [3] 0 0
IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.
Timepoint [3] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [4] 0 0
Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions
Assessment method [4] 0 0
Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.
Timepoint [4] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [5] 0 0
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions
Assessment method [5] 0 0
The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as "unknown deaths," but were counted as CV deaths for the analysis of this endpoint.
Timepoint [5] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [6] 0 0
Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions
Assessment method [6] 0 0
The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.
Timepoint [6] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [7] 0 0
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
Assessment method [7] 0 0
The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme \>= 2x the ULN or CK \> 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.
Timepoint [7] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [8] 0 0
Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
Assessment method [8] 0 0
The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Timepoint [8] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [9] 0 0
Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions
Assessment method [9] 0 0
Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.
Timepoint [9] 0 0
Baseline through End of Study (up to 7.5 years)
Primary outcome [10] 0 0
Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions
Assessment method [10] 0 0
The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.
Timepoint [10] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [1] 0 0
Number of Participants With Cardiovascular Events and All-cause Deaths
Assessment method [1] 0 0
Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.
Timepoint [1] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [2] 0 0
Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths
Assessment method [2] 0 0
The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.
Timepoint [2] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [3] 0 0
Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum
Assessment method [3] 0 0
Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.
Timepoint [3] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [4] 0 0
Number of Participants With CV/Microvascular Events
Assessment method [4] 0 0
The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.
Timepoint [4] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [5] 0 0
Number of Participants With Glycaemic Failure Events
Assessment method [5] 0 0
Failure of glycaemic control was defined as two consecutive HbA1c values of =8.5 percent, or HbA1c =8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.
Timepoint [5] 0 0
Baseline through to end of randomised dual therapy
Secondary outcome [6] 0 0
Number of Participants With Addition of Third Oral Agent/Switch to Insulin
Assessment method [6] 0 0
The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.
Timepoint [6] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [7] 0 0
The Number of Participants Starting Insulin at Any Time During the Study
Assessment method [7] 0 0
The number of participants starting insulin at any time during the study was recorded.
Timepoint [7] 0 0
Baseline through End of Study (up to 7.5 years)
Secondary outcome [8] 0 0
Model Adjusted Change From Baseline in HbA1c at Month 60
Assessment method [8] 0 0
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.
Timepoint [8] 0 0
Baseline and Month 60 of randomised dual therapy treatment period
Secondary outcome [9] 0 0
Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60
Assessment method [9] 0 0
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.
Timepoint [9] 0 0
Baseline to Month 60 of the randomised dual therapy treatment period
Secondary outcome [10] 0 0
Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60
Assessment method [10] 0 0
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.
Timepoint [10] 0 0
Baseline to Month 60 of the randomised dual therapy treatment period
Secondary outcome [11] 0 0
Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60
Assessment method [11] 0 0
Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)
Timepoint [11] 0 0
Baseline to Month 60 of the randomised dual therapy treatment period
Secondary outcome [12] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60
Assessment method [12] 0 0
The model adjusted (adjusted for any imbalances in the baseline \[BL\] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\*\[GM\^-1\]).
Timepoint [12] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [13] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60
Assessment method [13] 0 0
The model adjusted (adjusted for any imbalances in the baseline \[BL\] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\*\[GM\^-1\]).
Timepoint [13] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [14] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60
Assessment method [14] 0 0
The model adjusted (adjusted for any imbalances in the baseline \[BL\] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\*\[GM\^-1\]).
Timepoint [14] 0 0
Baseline to Month 60 of the randomised dual therapy treatment period
Secondary outcome [15] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60
Assessment method [15] 0 0
The model adjusted (adjusted for any imbalances in the baseline \[BL\] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\*\[GM\^-1\]).
Timepoint [15] 0 0
Baseline to Month 60 of the randomised dual therapy treatment period
Secondary outcome [16] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60
Assessment method [16] 0 0
The model adjusted (adjusted for any imbalances in the baseline \[BL\] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\*\[GM\^-1\]).
Timepoint [16] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [17] 0 0
Model Adjusted Change From Baseline in Body Weight at Month 60
Assessment method [17] 0 0
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.
Timepoint [17] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [18] 0 0
Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60
Assessment method [18] 0 0
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.
Timepoint [18] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [19] 0 0
Model Adjusted Change From Baseline in Waist Circumference at Month 60
Assessment method [19] 0 0
Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.
Timepoint [19] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [20] 0 0
Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60
Assessment method [20] 0 0
Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.
Timepoint [20] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [21] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60
Assessment method [21] 0 0
The model adjusted (adjusted for any imbalances in the baseline \[BL\] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\*\[GM\^-1\]).
Timepoint [21] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [22] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60
Assessment method [22] 0 0
The model adjusted (adjusted for any imbalances in the baseline \[BL\] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\*\[GM\^-1\]).
Timepoint [22] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [23] 0 0
Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60
Assessment method [23] 0 0
The model adjusted (adjusted for any imbalances in the baseline \[BL\] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\*\[GM\^-1\]).
Timepoint [23] 0 0
Baseline to Month 60 of the randomised dual therapy treatment phase
Secondary outcome [24] 0 0
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined
Assessment method [24] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Timepoint [24] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [25] 0 0
Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up
Assessment method [25] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Timepoint [25] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [26] 0 0
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined
Assessment method [26] 0 0
The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Timepoint [26] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [27] 0 0
Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up
Assessment method [27] 0 0
The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Timepoint [27] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [28] 0 0
Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined
Assessment method [28] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Timepoint [28] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [29] 0 0
Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up
Assessment method [29] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Timepoint [29] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [30] 0 0
Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined
Assessment method [30] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Timepoint [30] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [31] 0 0
Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up
Assessment method [31] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Timepoint [31] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [32] 0 0
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined
Assessment method [32] 0 0
The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Timepoint [32] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [33] 0 0
Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up
Assessment method [33] 0 0
The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Timepoint [33] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [34] 0 0
Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined
Assessment method [34] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Timepoint [34] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [35] 0 0
Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined
Assessment method [35] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Timepoint [35] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [36] 0 0
Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up
Assessment method [36] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Timepoint [36] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [37] 0 0
Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined
Assessment method [37] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).
Timepoint [37] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [38] 0 0
Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined
Assessment method [38] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown).
Timepoint [38] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [39] 0 0
Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined
Assessment method [39] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant.
Timepoint [39] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [40] 0 0
Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up
Assessment method [40] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
Timepoint [40] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [41] 0 0
Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined
Assessment method [41] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
Timepoint [41] 0 0
From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)
Secondary outcome [42] 0 0
Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up
Assessment method [42] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included "Unknown" as a category. Fracture events with missing outcome data were reported as "Data unavailable."
Timepoint [42] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)
Secondary outcome [43] 0 0
Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up
Assessment method [43] 0 0
The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.
Timepoint [43] 0 0
From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)

Eligibility
Key inclusion criteria
* Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria.
* Glycated haemoglobin (HbA1c) >7.0 % to = 9.0 % at visit 1.
* Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening.
* Body mass index >25.0 kg/m2.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea.
* Patients with systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg.
* Patients who have required the use of insulin for glycaemic control at any time in the past.
* Hospitalisation for any major cardiovascular event in the last 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
4447
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Miranda
Recruitment hospital [2] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [3] 0 0
GSK Investigational Site - Wollongong
Recruitment hospital [4] 0 0
GSK Investigational Site - Carina Heights
Recruitment hospital [5] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [6] 0 0
GSK Investigational Site - Sherwood
Recruitment hospital [7] 0 0
GSK Investigational Site - Keswick
Recruitment hospital [8] 0 0
GSK Investigational Site - North Adelaide
Recruitment hospital [9] 0 0
GSK Investigational Site - Port Lincoln
Recruitment hospital [10] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [11] 0 0
GSK Investigational Site - Malvern
Recruitment postcode(s) [1] 0 0
2228 - Miranda
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4152 - Carina Heights
Recruitment postcode(s) [5] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [6] 0 0
4075 - Sherwood
Recruitment postcode(s) [7] 0 0
5035 - Keswick
Recruitment postcode(s) [8] 0 0
5006 - North Adelaide
Recruitment postcode(s) [9] 0 0
5606 - Port Lincoln
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Arlon
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Edegem
Country [5] 0 0
Belgium
State/province [5] 0 0
Genk
Country [6] 0 0
Belgium
State/province [6] 0 0
Gent
Country [7] 0 0
Belgium
State/province [7] 0 0
Kortrijk
Country [8] 0 0
Belgium
State/province [8] 0 0
Liège
Country [9] 0 0
Belgium
State/province [9] 0 0
Moerkerke
Country [10] 0 0
Belgium
State/province [10] 0 0
Oostham
Country [11] 0 0
Belgium
State/province [11] 0 0
Roeselare
Country [12] 0 0
Belgium
State/province [12] 0 0
Sint Gillis-Waas
Country [13] 0 0
Belgium
State/province [13] 0 0
Vilvoorde
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Pleven
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Plovdiv
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Sofia
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Varna
Country [18] 0 0
Croatia
State/province [18] 0 0
Krapinske Toplice
Country [19] 0 0
Croatia
State/province [19] 0 0
Rijeka
Country [20] 0 0
Croatia
State/province [20] 0 0
Slavonski Brod
Country [21] 0 0
Croatia
State/province [21] 0 0
Varaždin
Country [22] 0 0
Croatia
State/province [22] 0 0
Zagreb
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Brno
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Ceske Budejovice
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Holice V Cechach
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Hradec Kralove
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Jindrichuv Hradec
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Ostrava Poruba
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Pisek
Country [30] 0 0
Czech Republic
State/province [30] 0 0
Praha 2
Country [31] 0 0
Czech Republic
State/province [31] 0 0
Praha 4
Country [32] 0 0
Czech Republic
State/province [32] 0 0
Rakovnik
Country [33] 0 0
Czech Republic
State/province [33] 0 0
Tabor
Country [34] 0 0
Czech Republic
State/province [34] 0 0
Trutnov
Country [35] 0 0
Denmark
State/province [35] 0 0
Aalborg
Country [36] 0 0
Denmark
State/province [36] 0 0
Aarhus
Country [37] 0 0
Denmark
State/province [37] 0 0
Copenhagen
Country [38] 0 0
Denmark
State/province [38] 0 0
Glostrup
Country [39] 0 0
Denmark
State/province [39] 0 0
Hilleroed
Country [40] 0 0
Denmark
State/province [40] 0 0
Koge
Country [41] 0 0
Denmark
State/province [41] 0 0
Kolding
Country [42] 0 0
Denmark
State/province [42] 0 0
København NV
Country [43] 0 0
Denmark
State/province [43] 0 0
Naestved
Country [44] 0 0
Denmark
State/province [44] 0 0
Odense C
Country [45] 0 0
Denmark
State/province [45] 0 0
Silkeborg
Country [46] 0 0
Denmark
State/province [46] 0 0
Slagelse
Country [47] 0 0
Estonia
State/province [47] 0 0
Paide
Country [48] 0 0
Estonia
State/province [48] 0 0
Parnu
Country [49] 0 0
Estonia
State/province [49] 0 0
Rakvere
Country [50] 0 0
Estonia
State/province [50] 0 0
Saku
Country [51] 0 0
Estonia
State/province [51] 0 0
Tallinn
Country [52] 0 0
Estonia
State/province [52] 0 0
Tartu
Country [53] 0 0
Estonia
State/province [53] 0 0
Viljandi
Country [54] 0 0
Finland
State/province [54] 0 0
Espoo
Country [55] 0 0
Finland
State/province [55] 0 0
Hanko
Country [56] 0 0
Finland
State/province [56] 0 0
Helsinki
Country [57] 0 0
Finland
State/province [57] 0 0
Hyvinkaa
Country [58] 0 0
Finland
State/province [58] 0 0
Jyväskylä
Country [59] 0 0
Finland
State/province [59] 0 0
Kerava
Country [60] 0 0
Finland
State/province [60] 0 0
Kuopio
Country [61] 0 0
Finland
State/province [61] 0 0
Lahti
Country [62] 0 0
Finland
State/province [62] 0 0
Lappeenranta
Country [63] 0 0
Finland
State/province [63] 0 0
Oulun kaupunki
Country [64] 0 0
Finland
State/province [64] 0 0
Riihimäki
Country [65] 0 0
Finland
State/province [65] 0 0
Rovaniemi
Country [66] 0 0
Finland
State/province [66] 0 0
Seinajoki
Country [67] 0 0
Finland
State/province [67] 0 0
Tampere
Country [68] 0 0
Finland
State/province [68] 0 0
Turku
Country [69] 0 0
France
State/province [69] 0 0
Nord-Pas-de-Calais
Country [70] 0 0
France
State/province [70] 0 0
Amilly
Country [71] 0 0
France
State/province [71] 0 0
Arras
Country [72] 0 0
France
State/province [72] 0 0
Aspach le Bas 68700
Country [73] 0 0
France
State/province [73] 0 0
Aubagne
Country [74] 0 0
France
State/province [74] 0 0
Auchy les Hesdin
Country [75] 0 0
France
State/province [75] 0 0
Azille
Country [76] 0 0
France
State/province [76] 0 0
Beaumont Le Roger
Country [77] 0 0
France
State/province [77] 0 0
Beaumont sur Leze
Country [78] 0 0
France
State/province [78] 0 0
Belfort
Country [79] 0 0
France
State/province [79] 0 0
Belpech
Country [80] 0 0
France
State/province [80] 0 0
Blotzheim
Country [81] 0 0
France
State/province [81] 0 0
Bondy
Country [82] 0 0
France
State/province [82] 0 0
BP 1542 Dijon
Country [83] 0 0
France
State/province [83] 0 0
Broglie
Country [84] 0 0
France
State/province [84] 0 0
Calmont
Country [85] 0 0
France
State/province [85] 0 0
Carbonne
Country [86] 0 0
France
State/province [86] 0 0
Carcassonne 11000
Country [87] 0 0
France
State/province [87] 0 0
Carcassonne
Country [88] 0 0
France
State/province [88] 0 0
Cassis
Country [89] 0 0
France
State/province [89] 0 0
Castelnaudary
Country [90] 0 0
France
State/province [90] 0 0
Catelnaudary
Country [91] 0 0
France
State/province [91] 0 0
Cernay
Country [92] 0 0
France
State/province [92] 0 0
Champhol
Country [93] 0 0
France
State/province [93] 0 0
Chartres
Country [94] 0 0
France
State/province [94] 0 0
Colmar
Country [95] 0 0
France
State/province [95] 0 0
Corbeil Essonne
Country [96] 0 0
France
State/province [96] 0 0
Coursan
Country [97] 0 0
France
State/province [97] 0 0
Cuincy
Country [98] 0 0
France
State/province [98] 0 0
Danjoutin
Country [99] 0 0
France
State/province [99] 0 0
Dessenheim
Country [100] 0 0
France
State/province [100] 0 0
Dieppe
Country [101] 0 0
France
State/province [101] 0 0
Dunkerque
Country [102] 0 0
France
State/province [102] 0 0
Epernon
Country [103] 0 0
France
State/province [103] 0 0
Gemenos
Country [104] 0 0
France
State/province [104] 0 0
Hanches
Country [105] 0 0
France
State/province [105] 0 0
Hautot sur Mer
Country [106] 0 0
France
State/province [106] 0 0
Husseren Wesserling
Country [107] 0 0
France
State/province [107] 0 0
Kembs
Country [108] 0 0
France
State/province [108] 0 0
La Barre En Ouche
Country [109] 0 0
France
State/province [109] 0 0
La Verdière
Country [110] 0 0
France
State/province [110] 0 0
Labarth-Sur-Leze
Country [111] 0 0
France
State/province [111] 0 0
Labarthe-Sur-Leze
Country [112] 0 0
France
State/province [112] 0 0
Le Grau Du Roi
Country [113] 0 0
France
State/province [113] 0 0
Le Lherm 31600
Country [114] 0 0
France
State/province [114] 0 0
Le Perray En Yvelines
Country [115] 0 0
France
State/province [115] 0 0
Lezignan-Corbières
Country [116] 0 0
France
State/province [116] 0 0
Maintenon
Country [117] 0 0
France
State/province [117] 0 0
Marseille
Country [118] 0 0
France
State/province [118] 0 0
Masevaux
Country [119] 0 0
France
State/province [119] 0 0
Maubeuge
Country [120] 0 0
France
State/province [120] 0 0
Monfort sur Risle
Country [121] 0 0
France
State/province [121] 0 0
Mulhouse
Country [122] 0 0
France
State/province [122] 0 0
Muret
Country [123] 0 0
France
State/province [123] 0 0
Nassandres
Country [124] 0 0
France
State/province [124] 0 0
Nevers cedex
Country [125] 0 0
France
State/province [125] 0 0
Nogent le Phaye
Country [126] 0 0
France
State/province [126] 0 0
Orbec
Country [127] 0 0
France
State/province [127] 0 0
Paris
Country [128] 0 0
France
State/province [128] 0 0
Pierre Benite Cedex
Country [129] 0 0
France
State/province [129] 0 0
Pierres
Country [130] 0 0
France
State/province [130] 0 0
Pinsaguel
Country [131] 0 0
France
State/province [131] 0 0
Roux Mesnil Bouteille
Country [132] 0 0
France
State/province [132] 0 0
Rugles
Country [133] 0 0
France
State/province [133] 0 0
Saint Leger sur Yvelines
Country [134] 0 0
France
State/province [134] 0 0
Saint-Eulalie Badens
Country [135] 0 0
France
State/province [135] 0 0
Seysses
Country [136] 0 0
France
State/province [136] 0 0
Thann
Country [137] 0 0
France
State/province [137] 0 0
Thiberville
Country [138] 0 0
France
State/province [138] 0 0
Toulouse
Country [139] 0 0
France
State/province [139] 0 0
Trebbes
Country [140] 0 0
France
State/province [140] 0 0
Trebes
Country [141] 0 0
France
State/province [141] 0 0
Valenciennes
Country [142] 0 0
France
State/province [142] 0 0
Vogelsheim
Country [143] 0 0
France
State/province [143] 0 0
Voves
Country [144] 0 0
France
State/province [144] 0 0
Wittenheim
Country [145] 0 0
Germany
State/province [145] 0 0
Baden-Wuerttemberg
Country [146] 0 0
Germany
State/province [146] 0 0
Bayern
Country [147] 0 0
Germany
State/province [147] 0 0
Hessen
Country [148] 0 0
Germany
State/province [148] 0 0
Niedersachsen
Country [149] 0 0
Germany
State/province [149] 0 0
Nordrhein-Westfalen
Country [150] 0 0
Germany
State/province [150] 0 0
Rheinland-Pfalz
Country [151] 0 0
Germany
State/province [151] 0 0
Saarland
Country [152] 0 0
Germany
State/province [152] 0 0
Sachsen
Country [153] 0 0
Germany
State/province [153] 0 0
Thueringen
Country [154] 0 0
Germany
State/province [154] 0 0
Hamburg
Country [155] 0 0
Greece
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Worle, Weston-Super-Mare

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00379769