Efficacy and Safety In Poorly Controlled Type 2 Diabetics

• Status: Completed
• Trial end date: 2003-04-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Rosiglitazone

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.