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

GlaxoSmithKline23 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Insulin-Dependent Diabetes Mellitus

Interventions

rosiglitazone-metformin fixed dose combinationDRUG

metformin + glimepirideDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment