Official Title: “A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.”

This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: metformin
• Drug: sulphonylurea
• Drug: Avandamet

Primary Measures

• Change in HbA1c level from baseline following 52 weeks of treatment.

Secondary Measures

• Change in FPG (fasting plasma glucose)
• insulin sensitivity
• beta cell function
• change in PAI-1
• CRP
• number of hypoglycaemic events
• Change in 24 hr ABPM
• Diabetes treatment satisfaction.

Inclusion criteria:

• Body mass index > or = to 25 kg/m2.
• HbA1c > or =7% and < or =10% at screening.
• FPG > or = 7.0mmol/L (126mg/dL) at visit 2.
• Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a.
• Female subjects must be postmenopausal or using effective contraceptive measures.

Exclusion criteria:

• Use of any other oral antidiabetic drug other than metformin within 12 weeks prior to screening.
• Subjects with clinically significant ongoing oedema requiring pharmacological treatment or with a history of oedema requiring pharmacological treatment.
• Subjects with a history of severe hypoglycaemia.
• Renal disease or renal dysfunction.
• Presence of clinically significant hepatic disease.
• Presence of unstable or severe angina or known NYHA grade I-IV congestive heart failure.
• Subjects who have had a previous myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft or cerebrovascular accident within 3 months prior to screening.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, DM, FRCP Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on March 11, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00359112

Study ID Number: AVM100264

ClinicalTrials.gov Identifier: NCT00359112

Health Authority: Germany: Federal Institute for Drugs and Medical Devices