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Efficacy and Safety In Poorly Controlled Type 2 Diabetics

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: NCT00044460
Recruitment Status : Completed
First Posted : August 30, 2002
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: rosiglitazone Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2002
Primary Completion Date : April 10, 2003
Study Completion Date : April 10, 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Change in HbA1c from baseline to Week 24.

Secondary Outcome Measures :
  1. Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044460


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

Additional Information:
Publications:
Abstract: The Effects of Rosiglitazone in Poorly-Controlled, Drug-Naive Patients with Type 2 Diabetes Mellitus, KATHLEEN L. WYNE, ALEXANDER R. COBITZ, BRIAN R. WATERHOUSE, LEANNE J. STROW. Dallas, TX; King of Prussia, PA; Orlando, FL; USA. 64th Annual Scientific Sessions of the American Diabetes Association. 6/4/2004
Wyne KL, Cobitz AR, Waterhouse BR, Strow LJ. The effects of rosiglitazone in poorly-controlled drug-naive patients with type 2 diabetes mellitus. Diabetes 2004;53(Suppl 2):A152. Poster 639 presented at ADA

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 49653/326
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 49653/326
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: 49653/326
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: 49653/326
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 49653/326
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 49653/326
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: 49653/326
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00044460     History of Changes
Other Study ID Numbers: 49653/326
First Posted: August 30, 2002    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by GlaxoSmithKline:
Type 2 diabetes drug-naive

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs