AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes

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.

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 Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, DM, FRCP Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 09, 2012

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