Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Camperdown, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone maleate/metformin hydrochloride

Drug

rosiglitazone maleate/metformin hydrochloride

Primary outcomes

Change from baseline in hemoglobin A1c (HbA1c) at week 32.

Time frame: at 32 week

Secondary outcomes

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

Time frame: at 32 weeksInvalid value

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Jul 11, 2007
Registry last updated: Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed