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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00499707
Recruitment Status : Completed
First Posted : July 11, 2007
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE July 9, 2007
First Posted Date  ICMJE July 11, 2007
Last Update Posted Date March 21, 2018
Study Start Date  ICMJE October 8, 2003
Actual Primary Completion Date December 1, 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
Change from baseline in hemoglobin A1c (HbA1c) at week 32. [ Time Frame: at 32 week ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2007)
Change from baseline in hemoglobin A1c (HbA1c) at week 32. [ Time Frame: 32 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2007)
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: 32 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Drug: rosiglitazone maleate/metformin hydrochloride
rosiglitazone maleate/metformin hydrochloride
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2007)
453
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 16, 2004
Actual Primary Completion Date December 1, 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   Korea, Republic of,   Mexico,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00499707
Other Study ID Numbers  ICMJE 712753/007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP