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Efficacy and Safety In Poorly Controlled Type 2 Diabetics

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00044460
First received: August 29, 2002
Last updated: September 22, 2016
Last verified: September 2016
  Purpose
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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: rosiglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

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

Estimated Enrollment: 142
Study Start Date: May 2002
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: 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 
Study First Received: August 29, 2002
Last Updated: September 22, 2016
Health Authority: Mexico: National Institute of Public Health, Health Secretariat
Canada: Health Canada
United States: Food and Drug Administration
Individual Participant Data  
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

ClinicalTrials.gov processed this record on December 06, 2016