Efficacy and Safety In Poorly Controlled Type 2 Diabetics

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: August 29, 2002
Last updated: June 1, 2011
Last verified: June 2011

August 29, 2002
June 1, 2011
May 2002
April 2003   (final data collection date for primary outcome measure)
Change in HbA1c from baseline to Week 24.
Not Provided
Complete list of historical versions of study NCT00044460 on ClinicalTrials.gov Archive Site
Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24.
Not Provided
Not Provided
Not Provided
Efficacy and Safety In Poorly Controlled Type 2 Diabetics
A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus
The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.
Not Provided
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Non-insulin-dependent Diabetes Mellitus
Drug: rosiglitazone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2003
April 2003   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Type 2 diabetes
  • Drug-naive.
  • Laboratory test result for HbA1c of greater than or equal to 10%.
  • Written informed consent.

Exclusion criteria:

  • Prior use of antidiabetic medications within 3 months of screening.
  • Fluid retention (edema).
  • Significant liver disease.
  • Low red blood cells (anemia).
  • Severe or unstable angina (chest pain).
  • Congestive heart failure.
  • Severe high blood pressure.
  • Alcohol or drug abuse.
  • Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Mexico
Not Provided
Not Provided
Not Provided
Cheri A. Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
Not Provided
Study Director: GSK Clinical Trial, MD, PhD GlaxoSmithKline
June 2011

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