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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00499707
First received: July 9, 2007
Last updated: June 21, 2012
Last verified: March 2011
History of Changes
  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
Diabetes Mellitus, Type 2
 Drug: rosiglitazone maleate/metformin hydrochloride
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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
Intervention Details:
    Drug: rosiglitazone maleate/metformin hydrochloride
    Other Name: rosiglitazone maleate/metformin hydrochloride
  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 92 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials 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: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00499707     History of Changes
Other Study ID Numbers: 712753/007
Study First Received: July 9, 2007
Last Updated: June 21, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HbA1c
Drug-naive
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Maleic acid
Rosiglitazone
 Metformin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013