Efficacy and Safety In Poorly Controlled Type 2 Diabetics
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00044460
First received: August 29, 2002
Last updated: June 1, 2011
Last verified: June 2011
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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
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| 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 May 16, 2013