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Avandamet vs Metformin in Type 2 Diabetes
NCT00386100Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2006
- Primary completion
- Sep 2009
- Countries
- 9
- Sponsor
- GSK
- Modality
- Small Molecules
- Drugs
- rosiglitazone
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 4, randomised, double-blind trial of rosiglitazone in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by GSK. Primary endpoint: Change From Baseline in HbA1c at Week 80. Started Oct 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Avandamet
Avandamet (Rosiglitazone/Metformin) titrated from 4mg/500mg to 8mg/2000mg daily
Metformin
Metformin titrated from 500mg to 2000mg daily
03
Who it enrols
Adult patients with type 2 diabetes, BMI > 25, HbA1c 7.5-10.5%, drug-naive (diet/exercise only), without significant renal, hepatic, or cardiac disease.
04
Endpoints
Primary
Change From Baseline in HbA1c at Week 80
Secondary
Number of Participants Achieving HbA1c <=6.5% and <7% at Week 80
Change in Fasting Plasma Glucose From Baseline at Week 80
Percent Change From Baseline in Total Cholesterol, LDL, HDL, and Triglycerides
Percent Change From Baseline in Lumbar Spine, Hip, and Total Body Bone Mineral Density
Percent Change From Baseline in Adiponectin
Percent Change From Baseline in C-reactive Protein
Change in Fasting Insulin and C-peptide
05
Results
Primary endpoints met
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