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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: August 31, 2016
Last verified: August 2016
  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
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 (Subject, Investigator)
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:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in hemoglobin A1c (HbA1c) at week 32. [ Time Frame: at 32 week ]

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 [ Time Frame: at 32 weeksInvalid value ]

Enrollment: 453
Study Start Date: October 2003
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rosiglitazone maleate/metformin hydrochloride
    rosiglitazone maleate/metformin hydrochloride
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 102 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Chou H., et. al.; Rosiglitazone and metformin fixed-dose combination provides superior glycaemic control compared to metformin and rosiglitazone monotherapies, and was well tolerated in drug-naïve patients with T2DM [poster]; European Association for the Study of Diabetes, 10-15 September 2005, Athens, Greece.

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 712753/007
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 712753/007
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 712753/007
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 712753/007
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 712753/007
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 712753/007
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 712753/007
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00499707     History of Changes
Other Study ID Numbers: 712753/007 
Study First Received: July 9, 2007
Last Updated: August 31, 2016
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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Metformin
Maleic acid
Hypoglycemic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016