24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes
Condition: Non-Insulin-Dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: rosiglitazone-metformin fixed dose combination; metformin + glimepiride
Intervention MeSH terms: Metformin; Glimepiride; Rosiglitazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: type 2 diabetes; rosiglitazone; metformin; glimepiride; glycemia

Summary:

      A better glycemic control is associated with less complications (cardiac diseases, blindness,
      etcetera) for type 2 diabetic patients. The objective is to study if rosiglitazone may lead
      to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than
      with a sulphonylurea (glimepiride).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged 40 to 80 years

          -  Diagnosis of type 2 diabetes mellitus for at least 6 months

          -  Body mass index (BMI) ≥25kg/m2

          -  7%≥HbA1c ≤ 9% at visit 2

          -  Treatment with metformin between 1.7g/day and 3g/day for at least 12 weeks prior to
             visit 1

          -  Female subjects must be non-pregnant, post-menopausal, surgically sterile or using
             effective contraceptive measures

          -  Written informed consent

        Exclusion Criteria:

          -  Use of any oral antidiabetic drug other than metformin within 12 weeks prior to
             screening

          -  Significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds with
             similar chemical structure

          -  Subjects who have required the use of insulin for glycaemic control at any time in the
             past or subject with a history of metabolic acidosis including diabetic ketoacidosis

          -  Subjects with clinically significant ongoing oedema or with a history of oedema in the
             12 months prior to visit 1

          -  Subjects with a history of severe hypoglycaemia

          -  Anemia defined by haemoglobin concentration <11.0g/dL for males or <10.0g/dL for
             females

          -  Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels
             ≥135µmol/L in males and ≥110µmol/L in females

          -  Presence of clinically significant hepatic disease (i.e. ALT, AST, total bilirubin or
             alkaline phosphatase >2.5 times the upper limit of the normal reference range)

          -  Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent
             myocardial infarction

          -  Subjects with chronic diseases requiring periodic or intermittent treatment with oral
             or intravenous corticosteroids

          -  Female who are lactating, pregnant, or planning to become pregnant

          -  Any clinically significant abnormality identified at screening which in the judgement
             of the investigator makes the subject unsuitable for inclusion in the study (e.g.
             physical examination, laboratory test, ECG, ...)

          -  Use of any investigational agent within 30 days or 5 half-lives (whichever is longer)
             prior to enrolment in this study

          -  Active alcohol, drug or medication abuse within the last 6 months or any condition
             that would indicate the likelihood of poor subject compliance

          -  Subjects not willing to comply with the procedures described in this protocol.