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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Metformin

Criteria

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.