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

Study Timeline

• Study Start: 2003-10-08
• Primary Completion: 2004-12-01
• Study Completion: 2004-12-16
• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-09
• Study First Posted: 2007-07-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-21

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