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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Non-Insulin-Dependent Diabetes Mellitus

Treatments

Drug: metformin

Drug: Avandamet

Drug: sulphonylurea

Study type

Interventional

Funder types

Industry

Identifiers

NCT00359112

AVM100264

Details and patient eligibility

About

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

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.