drugset / Trial / NCT00551564

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

NCT00551564

Phase 1 Completed 36 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2007-07-31
Primary completion
2008-09-08
Completion
2008-09-08

Publications

  • Background This study has not been published in the scientific literature.

Drugs

EvaluationDrugModalityDoseRoute
Subject Rosiglitazone Small molecule 4 mg Oral