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Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

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: NCT00279045
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE January 17, 2006
First Posted Date  ICMJE January 19, 2006
Last Update Posted Date November 29, 2017
Study Start Date  ICMJE January 3, 2000
Actual Primary Completion Date June 1, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2006)
Time from randomization to the primary action point (monotherapy failure).
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2006)
Time from randomization to the primary action point i.e.monotherapy failure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2007)
Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2006)
  • Compare effects of long-term treatment Rosiglitazone,Metformin,Glyburide:
  • - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
Official Title  ICMJE A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus
Brief Summary The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Rosiglitazone
  • Drug: glyburide
  • Drug: metformin
    Other Names:
    • glyburide
    • Rosiglitazone
Study Arms  ICMJE Not Provided
Publications *

*   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: April 10, 2015)
4426
Original Enrollment  ICMJE
 (submitted: January 17, 2006)
4100
Actual Study Completion Date  ICMJE June 19, 2006
Actual Primary Completion Date June 1, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Newly diagnosed patients (< 3years) with type 2 diabetes.
  • Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
  • No previous treatment with oral or parenteral glucose-lowering therapy.

Exclusion criteria:

  • History of lactic acidosis.
  • Anemia (<11g for males, <10 g for females).
  • Unstable or severe NY Heart Association-class 3 or 4.
  • Any NY Heart Association congestive heart failure.
  • Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 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 Austria,   Belgium,   Canada,   Czechia,   Denmark,   Finland,   France,   Germany,   Hungary,   Ireland,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Argentina,   Czech Republic,   Korea, Republic of
 
Administrative Information
NCT Number  ICMJE NCT00279045
Other Study ID Numbers  ICMJE 49653/048
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date November 2017

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