24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Glimepiride; Metformin; Rosiglitazone

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.