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

This study has been completed.

First Received: July 9, 2007 Last Updated: December 10, 2009 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00499707

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: rosiglitazone maleate/metformin hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Rosiglitazone Rosiglitazone Maleate Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	453
Study Start Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499707

Show 88 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

More Information

Additional Information:

http://ctr.gsk.co.uk/Summary/Rosiglitazone/III_712753_007.pdf This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	712753/007
Study First Received:	July 9, 2007
Last Updated:	December 10, 2009
ClinicalTrials.gov Identifier:	NCT00499707 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Drug-naive
HbA1c
type 2 diabetes

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Rosiglitazone
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010