Efficacy and Safety In Poorly Controlled Type 2 Diabetics

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00044460
First received: August 29, 2002
Last updated: June 1, 2011
Last verified: June 2011
  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
Non-insulin-dependent Diabetes Mellitus
Drug: rosiglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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.

Enrollment: 149
Study Start Date: May 2002
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044460

  Hide Study Locations
Locations
United States, Arizona
GSK Clinical Trials Call Center
Mesa, Arizona, United States, 85201
GSK Clinical Trials Call Center
Phoenix, Arizona, United States, 85014
GSK Clinical Trials Call Center
Tucson, Arizona, United States, 85745
GSK Clinical Trials Call Center
Tucson, Arizona, United States, 85712
United States, California
GSK Clinical Trials Call Center
Fair Oaks, California, United States, 70062
GSK Clinical Trials Call Center
Rolling Hills, California, United States, 90274
GSK Clinical Trials Call Center
San Francisco, California, United States, 94121
GSK Clinical Trials Call Center
Santa Rosa, California, United States, 95403
United States, Florida
GSK Clinical Trials Call Center
Tampa, Florida, United States, 33614
United States, Illinois
GSK Clinical Trials Call Center
Chicago, Illinois, United States, 60622
United States, Kansas
GSK Clinical Trials Call Center
Overland Park, Kansas, United States, 66210
United States, Kentucky
GSK Clinical Trials Call Center
Louisville, Kentucky, United States, 40291
United States, Louisiana
GSK Clinical Trials Call Center
Kenner, Louisiana, United States, 70062
United States, Maine
GSK Clinical Trials Call Center
Bangor, Maine, United States, 04401
United States, Minnesota
GSK Clinical Trials Call Center
Minneapolis, Minnesota, United States, 55417
GSK Clinical Trials Call Center
Minneapolis, Minnesota, United States, 55407
United States, Nevada
GSK Clinical Trials Call Center
Las Vegas, Nevada, United States, 89103
United States, New Jersey
GSK Clinical Trials Call Center
Bloomfield, New Jersey, United States, 07003
United States, Ohio
GSK Clinical Trials Call Center
Youngstown, Ohio, United States, 44505
United States, Oregon
GSK Clinical Trials Call Center
Medford, Oregon, United States, 97504
United States, Pennsylvania
GSK Clinical Trials Call Center
Allentown, Pennsylvania, United States, 18102
GSK Clinical Trials Call Center
Beaver, Pennsylvania, United States, 15009
GSK Clinical Trials Call Center
Downingtown, Pennsylvania, United States, 19335
GSK Clinical Trials Call Center
Feasterville, Pennsylvania, United States, 19053
GSK Clinical Trials Call Center
Philadelphia, Pennsylvania, United States, 19107
GSK Clinical Trials Call Center`
Philadelphia, Pennsylvania, United States, 19152
GSK Clinical Trials Call Center
Pittsburgh, Pennsylvania, United States, 15243
GSK Clinical Trials Call Center
Reading, Pennsylvania, United States, 10601
GSK Clinical Trials Call Center
Sellersville, Pennsylvania, United States, 18960
GSK Clinical Trials Call Center
Steelton, Pennsylvania, United States, 17113
United States, Rhode Island
GSK Clinical Trials Call Center
East Providence, Rhode Island, United States, 02914
United States, South Carolina
GSK Clinical Trials Call Center
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
GSK Clinical Trials Call Center`
Murfreesboro, Tennessee, United States, 37130
United States, Texas
GSK Clinical Trials Call Center
Dallas, Texas, United States, 75390
GSK Clinical Trials Call Center
Dallas, Texas, United States, 75230
GSK Clinical Trials Call Center
Georgetown, Texas, United States, 78626
GSK Clinical Trials Call Center
Midland, Texas, United States, 79705
GSK Clinical Trials Call Center
San Antonio, Texas, United States, 78221
GSK Clinical Trials Call Center
San Antonio, Texas, United States, 78229
United States, Virginia
GSK Clinical Trials Call Center
Norfolk, Virginia, United States, 23502
GSK Clinical Trials Call Center
Virginia Beach, Virginia, United States, 23455
Canada, British Columbia
GSK Clinical Trials Call Center
Coquitlam, British Columbia, Canada, V5K 3P4
GSK Clinical Trials Call Center
Vancouver, British Columbia, Canada, V5Z 2N6
Canada, Nova Scotia
GSK Clinical Trials Call Center
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
GSK Clinical Trials Call Center
Burlington, Ontario, Canada, L7R 2HD
GSK Clinical Trials Call Center
Sudbury, Ontario, Canada, P3E 6B4
GSK Clinical Trials Call Center
Windsor, Ontario, Canada, N8X 1K4
Canada, Quebec
GSK Clinical Trials Call Center
Bastien Neufchatel, Quebec, Canada, G2B 1B5
GSK Clinical Trials Call Center
Sherbrooke, Quebec, Canada, J1J 2B8
GSK Clinical Trials Call Center
Sherbrooke, Quebec, Canada, J1G 5K2
Mexico
GSK Clinical Trials Call Center
Durango, Mexico, 34000
GSK Clinical Trials Call Center
Guadalajara, Mexico, 44340
GSK Clinical Trials Call Center
Mexico D.F., Mexico, 06720
GSK Clinical Trials Call Center
Mitras Centro Monterrey, N.L., Mexico, 64460
GSK Clinical Trials Call Center
Tijuana, Mexico, 22320
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trial, MD, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri A. Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00044460     History of Changes
Other Study ID Numbers: 49653/326
Study First Received: August 29, 2002
Last Updated: June 1, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: National Institute of Public Health, Health Secretariat

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014