Efficacy and Safety In Poorly Controlled Type 2 Diabetics

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: rosiglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00044460

49653/326

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind