Last updated: 11/02/2018 23:40:33

Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes

GSK study ID
101765
See study documents
Clinicaltrials.gov ID
NCT00367055
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Comparison of the action of the rosiglitazone-metformin fixed-dose combination and of a metformin-sulfonylurea free combination on the b-cell function in type 2 diabetic patients not controlled with metformin alone.
Trial description: It has been shown in previous study that progressive glycemic deterioration was associated with progressive loss of b-cell function, measured by the decrease in plasma insulin levels, irrespective of the therapy used (diet, sulfonylureas or metformin).There is growing evidence that thiazolidinediones could have a positive action on the b-cell function. But it has not yet been demonstrated that they could protect from a deterioration in insulin secretion in the long term. So, it appears interesting to study the long term evolution of the b-cell function and the possible protection with rosiglitazone in patients with type 2 diabetes showing evidence of loss of b-cell function with metformin alone.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Median change from baseline in the insulin secretory capacity after a 36-month treatment

Timeframe: Baseline and Month 36

Secondary outcomes:

Median change from baseline in the ratio M/I after a 36-month treatment

Timeframe: Baseline and Month 36

Median change from baseline in the insulin secretion capacity after an 18-month treatment

Timeframe: Baseline and Month 18

Mean change from baseline in HbA1c at Month 36

Timeframe: Baseline and Month 36

Mean change from baseline in FBG at Month 36

Timeframe: Baseline and Month 36

Median change from baseline in insulin resistance index (HOMA-IR) after a 36-month treatment

Timeframe: Baseline and Month 36

Median change from baseline in beta cell function index (HOMA-beta) after a 36-month treatment

Timeframe: Baseline and Month 36

Mean change from baseline in CPP total and incremental AUC T0-T30 after a 36-month treatment

Timeframe: Baseline and Month 36

Mean change from baseline in CPP concentration peak and incremental concentration peak T0-T30 after a 36-month treatment

Timeframe: Baseline and Month 36

Mean change from Baseline in insulin sensitivity index at Months 18 and 36

Timeframe: Baseline and Months 18 and 36

Interventions:
Drug: rosiglitazone-metformin
Drug: Metformin
Drug: metformin+ gliclazide
Enrollment:
84
Observational study model:
Not applicable
Primary completion date:
2008-02-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Type 2 Diabetes Mellitus
Product
rosiglitazone, rosiglitazone/metformin
Collaborators
Not applicable
Study date(s)
October 2004 to October 2008
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
40 - 75 Years
Accepts healthy volunteers
No
  • Males and females 40 to 75 years of age (inclusive at the time of screening)
  • Type 2 diabetes mellitus as defined by the WHO criteria, diagnosed for at least 1 year
  • Patient with type 1 diabetes
  • Treatment with other hypoglycaemic agents than metformin in the last 3 months
Inclusion and exclusion criteria
Inclusion criteria:
  • Males and females 40 to 75 years of age (inclusive at the time of screening)
  • Type 2 diabetes mellitus as defined by the WHO criteria, diagnosed for at least 1 year
  • Subjects receiving 1.5 to 3g of metformin alone at a constant dose for at least 8 weeks prior to visit 1
  • Patients with 6.5% < HbA1c > 8% at visit 1 and visit 2
  • 25 < BMI < 35
Exclusion criteria:
  • Patient with type 1 diabetes
  • Treatment with other hypoglycaemic agents than metformin in the last 3 months
  • FPG >200 mg/dL at visit 2
  • Hypersensitivity to the studied treatments (rosiglitazone, metformin chlorhydrate, gliclazide)
  • Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction
  • Respiratory insufficiency
  • Subjects who have required the use of insulin for glycaemic control in the past 6 months prior to visit 1 (except during pregnancy or acute episodes such as hospitalization, trauma or infection) or subjects with a history of metabolic acidosis including diabetic ketoacidosis
  • Anemia defined by haemoglobin concentration <11.0 g/dL for males and <10.0 g/dL for females
  • Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135.0 µmol/L in males and ≥110.0 µmol/L in females and/or creatinine clearance <40 mL/min
  • Presence of clinically significant hepatic disease, with ALT, AST, total bilirubin, alkaline phosphatase >2.5 times the upper limit of the normal reference range
  • Subjects with chronic diseases requiring periodic ot intermittent treatment with oral or IV corticosteroids
  • Subjects receiving danazol, miconazole or phenylbutazone
  • Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance
  • Women who are lactating, pregnant or planning to become pregnant
  • Any clinically significant abnormality identified at screening which, in the investigator's judgement, makes the subject unsuitable for inclusion in the study
  • Use of any other investigational agent within 30 days or 5 half-lives (whichever is longer) prior to visit 1
  • Subjects who receive or anticipate receiving radiocontrast dye during the study

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2008-02-10
Actual study completion date
2008-02-10

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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