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Trial registered on ANZCTR


Registration number
ACTRN12605000738628
Ethics application status
Approved
Date submitted
23/09/2005
Date registered
11/11/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
CGMS04
Scientific title
A randomized study comparing Diamicron MR and Amaryl once daily in people with well-controlled Type 2 Diabetes Mellitus whose current therapy includes sulphonylurea therapy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes mellitus 890 0
Condition category
Condition code
Metabolic and Endocrine 958 958 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This 31 week study is a single centre, randomised parallel group comparison with a crossover of treatment at 12 weeks. The study will consist of a 6 week run-in period of a stable dose of Diamicron equivelant to the previous sulphonylurea dose.(Table 4) Followed by a 12 week period to either Diamicron MR or Amaryl once daily in random order. (Table 3)

During the Diamicron run-in phase and prior to randomisation to either Diamicron MR or Amaryl, the patients will be fitted with the Minimed Continuous Glucose Monitor and instructed in the appropriate care and calibration procedure. Continuous monitoring will take place for three days.

Prior to crossover of treatment at 12 weeks and prior to completion of the study at 28 weeks, the Continuous Glucose Monitor will be re-fitted for 3 days monitoring of interstitial glucose values.
Intervention code [1] 666 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1258 0
1 To determine the number of hypoglycaemic events related to time of day e.g. nocturnal hypoglycaemia.
Timepoint [1] 1258 0
Primary outcome [2] 1259 0
2. To determine the number and extent of post prandial glycaemic excursions, greater than 8.0mmol/L and 10.0mmol/L
Timepoint [2] 1259 0
Primary outcome [3] 1260 0
3.To determine the incremental change of prandial glucose levels of greater than or equal to 2.2.mmol/L.
Timepoint [3] 1260 0
Primary outcome [4] 1261 0
4. To determine the number of hypoglycaemic events (i.e. a blood glucose reading of <2.8mmol/L) in total over the monitoring period, either symptomatic or asymptomatic, and the number of events per patient. (a hypoglycaemic event will be defined as 3 consecutive CGMS readings ie. of 15 minutes duration below 2.8mmol/L)
Timepoint [4] 1261 0
Primary outcome [5] 1262 0
5. To determine the number of borderline hypoglycaemic events (i.e. a blood glucose â¿¥ 2.8mmol/L and <3.6mmol/L) in total over the monitoring period either symptomatic or asymptomatic, and the number of events per patient. (a hypoglycaemic event will be defined as 3 consecutive CGMS readings ie. of 15 minutes duration between 2.8 and 3.6mmol/L)
Timepoint [5] 1262 0
Primary outcome [6] 1263 0
6. The average of the daily fasting blood glucose readings for 3 days prior to a study visit.
Timepoint [6] 1263 0
Secondary outcome [1] 2294 0
1. HbA1c
Timepoint [1] 2294 0
Secondary outcome [2] 2295 0
2. Fasting plasma glucose
Timepoint [2] 2295 0
Secondary outcome [3] 2296 0
3. Mean blood glucose levels, (2am - 4am) and (4am- 6am).
Timepoint [3] 2296 0
Secondary outcome [4] 2297 0
4. The 8am interstitial glucose level by the CGMS.
Timepoint [4] 2297 0
Secondary outcome [5] 2298 0
5. Sulphonylurea levels
Timepoint [5] 2298 0

Eligibility
Key inclusion criteria
1. Patients who have been informed of the study procedure and have given written informed consent. 2. Unequivocal diagnosis of Type 2 diabetes mellitus. 3. Glycosylated haemoglobin (HbA1c) 7.5%. 4. Currently regularly taking any sulphonylurea drug. May also be on one or more additional oral antidiabetic medications other than repaglinide. 5. Oral antidiabetic medication dose stable for at least 8 weeks.
Minimum age
50 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type 1 diabetes mellitus. 2. Unstable diabetes mellitus. 3. Myocardial infarction, transient ischaemic attacks or stroke in the last 6 months. 4. Symptomatic heart failure. 5. Diastolic blood pressure 100mmHg despite drug treatment. 6. Severe hepatic insufficiency. ALT 2.5 times the upper limit of the reference range. 7. Severe renal insufficiency. Serum creatinine 135­mol/L. 8. Haemoglobinopathy or haemoglobin 10.5g/dl9. Malignant disease in the previous 10 years (except basal cell carcinoma). 10. Conditions which may affect blood glucose levels including: 11. Recent surgery (within the last 6 weeks) or surgery scheduled during the study period. 12. Systemic or generalised infections (bacterial, viral or fungal), including intercurrent illnesses in the last 6 weeks. 13. Concomitant glucocorticoid drug therapy. 14. Cushing's or Addisons disease. 15. Patients known to be immunocompromised (e.g., lymphoma, AIDS). 16. Known hypersensitivity to glucose oxygenase, the enzyme contained in the monitor probe. 17. Concomitant insulin therapy. 18. hypersensitivity to gliclazide, glimepiride or other suphonylureas. 19. Miconazole treatment.

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)
To ensure the investigator is blinded to the treatment allocation for each participant, the study co-ordinator will down load the data from the CGMS. Data from each participant will be downloaded at the visits but will not be anlysed until the completion of the patients participation in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised using a randomisation list created by a table of random numbers. 50% will be assigned to Treatment A and the other 50% will be assigned Treatment B.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1056 0
Hospital
Name [1] 1056 0
Sydney Diabetes Clinical Research Unit, Royal North Shore Hospital
Country [1] 1056 0
Australia
Primary sponsor type
Other
Name
Sydney Diabetes Clinical Research Unit
Address
Country
Australia
Secondary sponsor category [1] 917 0
None
Name [1] 917 0
Nil
Address [1] 917 0
Country [1] 917 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35309 0
Address 35309 0
Country 35309 0
Phone 35309 0
Fax 35309 0
Email 35309 0
Contact person for public queries
Name 9855 0
Ms Louise Hay
Address 9855 0
Sydney Diabetes Clinical Research Unit
Royal North Shore Hospital
Level 3
Main Block
St Leonards NSW 2065
Country 9855 0
Australia
Phone 9855 0
+61 2 99266820
Fax 9855 0
+61 2 94395181
Email 9855 0
[email protected]
Contact person for scientific queries
Name 783 0
Ms Louise Hay
Address 783 0
Sydney Diabetes Clinical Research Unit
Royal North Shore Hospital
Level 3
Main Block
St Leonards NSW 2065
Country 783 0
Australia
Phone 783 0
+61 2 99266820
Fax 783 0
+61 2 94395181
Email 783 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.