Status:
COMPLETED
AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes
Lead Sponsor:
GlaxoSmithKline
Conditions:
Non-Insulin-Dependent Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
544 Patients enrolled
Trial Details
Trial ID
NCT00359112
Start Date
February 1 2004
Last Update
May 18 2009
Active Locations (142)
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1
GSK Investigational Site
Bruges, Belgium, 8000
2
GSK Investigational Site
Brussels, Belgium, 1030
3
GSK Investigational Site
Brussels, Belgium, 1210
4
GSK Investigational Site
Champion, Belgium, 5020