Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00499707
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 453
Inclusion Criteria
- 18 to 70 years of age
- Clinical diagnosis of type 2 diabetes
- HbA1c >7.5% to 11%
- FPG <270mg/dL (15mmol)
- Current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening
Exclusion Criteria
- Clinically significant renal or hepatic disease
- Presence of anemia
- Presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy
- Systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on anti-hypertensive treatment
- Chronic disease requiring intermittent or chronic treatment with corticosteroids
- Any female lactating, pregnant, or planning to become pregnant
- History of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione
- Presence of acute or chronic metabolic acidosis
- History of diabetic ketoacidosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in hemoglobin A1c (HbA1c) at week 32. at 32 week
- Secondary Outcome Measures
Name Time Method Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks at 32 weeksInvalid value
Trial Locations
- Locations (1)
GSK Investigational Site
🇳🇿Wellington, New Zealand