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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01798706




Registration number
NCT01798706
Ethics application status
Date submitted
22/02/2013
Date registered
26/02/2013
Date last updated
18/04/2017

Titles & IDs
Public title
Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients
Scientific title
A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter, 24 Week Study Assessing the Safety and Efficacy of Lixisenatide in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Diabetes Treatment Regimen
Secondary ID [1] 0 0
2012-003292-19
Secondary ID [2] 0 0
EFC12703
Universal Trial Number (UTN)
Trial acronym
GetGoal-O
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 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 - Lixisenatide (AVE0010)
Treatment: Drugs - Placebo
Treatment: Drugs - Antidiabetic background therapy

Experimental: Lixisenatide - Lixisenatide 10 mcg once daily (QD) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.

Placebo comparator: Placebo - Placebo (matched to lixisenatide) QD for 24 Weeks.


Treatment: Drugs: Lixisenatide (AVE0010)
Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning

Route of administration: Subcutaneous injection

Treatment: Drugs: Placebo
Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning

Route of administration: Subcutaneous injection

Treatment: Drugs: Antidiabetic background therapy
Participants received a stable regimen of anti-diabetic background therapy for at least 3 months prior to screening, during the placebo run-in period and the 24 week treatment period. Allowed background antidiabetic therapy included metformin, sulfonylurea (except glibenclamide \>10 mg, gliclazide \>160 mg), meglitinides (except repaglinide \>6 mg), pioglitazone and basal insulin. Insulin glargine, neutral protamine hagedorn (NPH) insulin, detemir, lente and ultralente were considered as basal insulin.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute Change in HbA1c From Baseline to Week 24
Assessment method [1] 0 0
Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed=participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Change in 2-Hour PPG From Baseline to Week 24
Assessment method [1] 0 0
The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [2] 0 0
Change in Average 7-point SMPG Profiles From Baseline to Week 24
Assessment method [2] 0 0
Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Change in Body Weight From Baseline to Week 24
Assessment method [3] 0 0
Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Change in FPG From Baseline to Week 24
Assessment method [4] 0 0
Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period
Assessment method [5] 0 0
Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \>270 mg/dL (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG \>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG \>200 mg/dL (11.1 mmol/L) or HbA1c \>9%.
Timepoint [5] 0 0
Baseline up to Week 24
Secondary outcome [6] 0 0
Change in Plasma Glucose Excursions From Baseline to Week 24
Assessment method [6] 0 0
Plasma glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the liquid standardized breakfast meal test, before study drug administration. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.
Timepoint [6] 0 0
Baseline, Week 24
Secondary outcome [7] 0 0
Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy)
Assessment method [7] 0 0
Change in basal insulin dose was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.
Timepoint [7] 0 0
Baseline, Week 24
Secondary outcome [8] 0 0
Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia
Assessment method [8] 0 0
Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.
Timepoint [8] 0 0
First dose of study drug up to 3 days after the last dose administration (maximum of 171 days)
Secondary outcome [9] 0 0
Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia
Assessment method [9] 0 0
The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.
Timepoint [9] 0 0
Week 24
Secondary outcome [10] 0 0
Percentage of Participants With Gastrointestinal Disorders
Assessment method [10] 0 0
Timepoint [10] 0 0
Up to Day 171

Eligibility
Key inclusion criteria
Inclusion criteria :

* Older participants, aged 70 years and above, with T2DM inadequately controlled on their current anti-diabetic pharmaceutical treatment regimen.
* Signed written informed consent.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* At screening HbA1c =7.0% or >10% (Acknowledging that the threshold of 7% may not be appropriate for all older participants and that this was the responsibility of the investigator to include the participant based on an individual evaluation of the expected benefits of better glycemic control versus risk of hypoglycemia).
* At screening participants on both basal insulin and sulfonylurea or basal insulin and meglitinides.
* At screening FPG >250 mg/dL (>13.9 mmol/L).
* Type 1 diabetes mellitus or history of ketoacidosis within one year prior to the screening visit.
* Type 2 diabetes mellitus diagnosed less than 1 year prior to screening.
* Anti-diabetic treatment not at a stable regimen or initiated within the last 3 months prior to screening.
* Treatment within the 3 months preceding the screening with other anti-diabetic agent than allowed background therapy. Allowed therapy includes metformin, sulfonylurea (except glibenclamide >10mg, gliclazide >160mg), meglitinides (except repaglinide >6mg), pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population.
* Participants who had been on an approved or an investigational Glucagon-like peptide 1 (GLP-1) medication (exenatide, liraglutide, lixisenatide or others).
* History of severe hypoglycemia associated with symptoms unawareness or results in unconsciousness/coma/seizure in the 6 months prior to screening.
* BMI <22 or >40 kg/m^2.
* Malnutrition assessed clinically by the investigator or any sub-investigator and by Mini-Nutritional Assessment-Short Form (MNA-SF) score <12 in countries (the judgment of the investigator prevails on questionnaires scores).
* Cognitive disorder and dementia assessed clinically by the investigator or any sub investigator and by Mini Mental State Examination (MMSE) score <24 (the judgment of the investigator prevails on questionnaires scores), or any neurologic disorder that affected the participant's ability to participate in the study.
* Participant who had a glomerular filtration rate (eGFR) (using the Modification of Diet in Renal Disease (MDRD) formula <30ml/min/1.73m^2).
* Participant with severe or uncontrolled disease, or any clinically significant abnormality identified on physical examination or investigational clinical procedure that, in the judgment of the investigator or any sub-investigator, would preclude safe completion of the study or constrains efficacy assessment.
* Laboratory findings at the time of screening:

* Amylase and/or lipase: >3 times the upper limit of the normal (ULN) laboratory range
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times ULN
* Calcitonin >20 pg/mL (5.9 pmol/L).
* Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e. worsening) and not controlled (i.e. prolonged nausea and vomiting) gastroesophageal reflux disease within 6 months prior to screening.
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.
* Personal or immediate family history of medullary thyroid cancer or genetic conditions that predisposed to medullary thyroid cancer (e.g., multiple endocrine neoplasia syndromes).

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036002 - Box Hill
Recruitment hospital [2] 0 0
Investigational Site Number 036006 - Brookvale
Recruitment hospital [3] 0 0
Investigational Site Number 036004 - Camperdown
Recruitment hospital [4] 0 0
Investigational Site Number 036005 - Gosford
Recruitment hospital [5] 0 0
Investigational Site Number 036001 - Heidelberg
Recruitment hospital [6] 0 0
Investigational Site Number 036003 - Parkville
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
2100 - Brookvale
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
North Dakota
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Plovdiv
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Sofia
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Stara Zagora
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Varna
Country [16] 0 0
Canada
State/province [16] 0 0
Hamilton
Country [17] 0 0
Canada
State/province [17] 0 0
London
Country [18] 0 0
Canada
State/province [18] 0 0
Sherbrooke
Country [19] 0 0
Canada
State/province [19] 0 0
St-Romuald
Country [20] 0 0
Canada
State/province [20] 0 0
Vancouver
Country [21] 0 0
Canada
State/province [21] 0 0
Westmount
Country [22] 0 0
Canada
State/province [22] 0 0
Winnipeg
Country [23] 0 0
Denmark
State/province [23] 0 0
Esbjerg
Country [24] 0 0
Denmark
State/province [24] 0 0
København Nv
Country [25] 0 0
Denmark
State/province [25] 0 0
København S
Country [26] 0 0
Denmark
State/province [26] 0 0
Slagelse
Country [27] 0 0
Denmark
State/province [27] 0 0
Svendborg
Country [28] 0 0
Germany
State/province [28] 0 0
Dresden
Country [29] 0 0
Germany
State/province [29] 0 0
Essen
Country [30] 0 0
Germany
State/province [30] 0 0
München
Country [31] 0 0
Germany
State/province [31] 0 0
Münster
Country [32] 0 0
Germany
State/province [32] 0 0
Pirna
Country [33] 0 0
Germany
State/province [33] 0 0
Pohlheim
Country [34] 0 0
Germany
State/province [34] 0 0
Potsdam
Country [35] 0 0
Germany
State/province [35] 0 0
Saarlouis
Country [36] 0 0
Norway
State/province [36] 0 0
Hønefoss
Country [37] 0 0
Norway
State/province [37] 0 0
Kongsvinger
Country [38] 0 0
Norway
State/province [38] 0 0
Oslo
Country [39] 0 0
Norway
State/province [39] 0 0
Stavanger
Country [40] 0 0
Norway
State/province [40] 0 0
Trondheim
Country [41] 0 0
Peru
State/province [41] 0 0
Arequipa
Country [42] 0 0
Peru
State/province [42] 0 0
Lima
Country [43] 0 0
Peru
State/province [43] 0 0
Piura
Country [44] 0 0
Poland
State/province [44] 0 0
Gdansk
Country [45] 0 0
Poland
State/province [45] 0 0
Krakow
Country [46] 0 0
Poland
State/province [46] 0 0
Poznan
Country [47] 0 0
Poland
State/province [47] 0 0
Ruda Slaska
Country [48] 0 0
Poland
State/province [48] 0 0
Szczecin
Country [49] 0 0
South Africa
State/province [49] 0 0
Cape Town
Country [50] 0 0
South Africa
State/province [50] 0 0
Somerset West
Country [51] 0 0
Spain
State/province [51] 0 0
Alcira
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Hostalets De Balenyà
Country [54] 0 0
Spain
State/province [54] 0 0
Madrid
Country [55] 0 0
Spain
State/province [55] 0 0
Sanlúcar De Barrameda
Country [56] 0 0
Spain
State/province [56] 0 0
Santiago De Compostela
Country [57] 0 0
Sweden
State/province [57] 0 0
Göteborg
Country [58] 0 0
Sweden
State/province [58] 0 0
Härnösand
Country [59] 0 0
Sweden
State/province [59] 0 0
Lund
Country [60] 0 0
Sweden
State/province [60] 0 0
Malmö
Country [61] 0 0
Sweden
State/province [61] 0 0
Stockholm
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Bexhill-On-Sea
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Glasgow
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Irvine
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Trowbridge

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

TypeCitations or Other Details
Journal Meneilly GS, Roy-Duval C, Alawi H, Dailey G, Belli... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01798706