Rosiglitazone-Metformin Combination Versus Metformin-Sulfonylurea Combination On Beta-Cell Function In Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: rosiglitazone-metformin; Metformin; metformin+ gliclazide
Intervention MeSH terms: Metformin; Rosiglitazone; Gliclazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Beta cell function; Type 2 diabetes; Combination treatment

Summary:

      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.
    

Eligibility 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