Efficacy and Safety In Poorly Controlled Type 2 Diabetics - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00044460

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 IV

MedlinePlus related topics: Diabetes

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

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
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

Show 57 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trial, MD, PhD

GlaxoSmithKline

More Information

Study ID Numbers:	49653/326
Study First Received:	August 29, 2002
Last Updated:	April 17, 2007
ClinicalTrials.gov Identifier:	NCT00044460
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

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009