Official Title: “Comparison of the Effects of Rosiglitazone and Glimepiride, Both Given in Combination With Metformin, on 24-Hour Glycemia in Type 2 Diabetes Patients Not Controlled With Metformin Alone. A 3-Month Multicentre, Randomized, Parallel-Group, Open-Label Study.”

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

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: rosiglitazone-metformin fixed dose combination
• Drug: metformin + glimepiride

Primary Measures

• Duration of hyperglycemia episodes over 24 hours in the 2 groups will be the main criterion to compare the two drugs using a device allowing continuous glycemic measures (CGMS).
• Effect of rosiglitazone and glimepiride on the number and duration of hypoglycaemic episodes

Secondary Measures

• Number of hyperglycemic episodes Number, duration of hypoglycemic episodes Post-meal glycemias HbA1c
• Post-prandial glycemia (2 hours after lunch), glycemia between 05.00pm and 07.00pm, number and time of episodes with glycemia >1,50g/l, number and time of episodes with glycemia <0.80g/l and below 0.6g/l.
• % of glucose values between 0.8g/l and 1.50g/l. HbA1c (mean, % responders) FPG (mean, % responders) AEs

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trial, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00318656

Study ID Number: 104988

ClinicalTrials.gov Identifier: NCT00318656

Health Authority: France: Afssaps - French Health Products Safety Agency