Non-Insulin-Dependent Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes, overweight, AVANDAMET, metformin, sulphonylurea
Brief summary
This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c level from baseline following 52 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| insulin sensitivity | — |
| beta cell function | — |
| change in PAI-1 | — |
| Change in FPG (fasting plasma glucose) | — |
| number of hypoglycaemic events | — |
| Change in 24 hr ABPM | — |
| Diabetes treatment satisfaction. | — |
| CRP | — |
Countries
Belgium, France, Germany, Ireland, Italy, Lithuania, Mexico, Netherlands, Spain, Switzerland, United Kingdom
Outcome results
None listed