Study to Determine the Utility of Novel Technologies and Biomarkers to Measure Human Response to Rosiglitazone Maleate

• Status: Completed
• Trial end date: 2008-09-08
• Target enrollment: 0
• Participant gender: All

Summary

Insulin resistance (IR) is common in many metabolic disorders and predisposes an individual to Type 2 Diabetes Mellitus (T2DM), the Metabolic Syndrome and coronary atherosclerosis. Non-diabetics with IR are at risk, but can be difficult to diagnose.

A major problem with the use of IR as a predictor or marker of disease is the lack of a simple, robust test that can be used to quantify this parameter in a wide variety of clinical situations. The current 'gold standard' methods for measuring insulin sensitivity, such as the hyperinsulinemic-euglycemic (H-E) clamp, are complex, time consuming and costly. Alternative, simpler methods, such as the Homeostasis Model Assessment (HOMA-IR) score, may be less accurate and are not widely accepted.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Maleic acid; Rosiglitazone

Criteria

Inclusion Criteria:

• Male and/or females aged 18-65 years

• Females must either be of non-childbearing potential or childbearing potential (but not pregnant) and using appropriate methods of contraception.

• Healthy normal or overweight control subjects or healthy obese subjects or subjects with T2DM.

Exclusion Criteria:

• Clinically significant past or current medical conditions

• Clinically significant abnormalities in vital signs or routine laboratory parameters