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

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00551564

Run by

GlaxoSmithKline

People needed

36

Starts

2007-07-31

Expected to finish

2008-09-08

Last updated by the study team

2017-08-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Clinically significant past or current medical conditions
• Clinically significant abnormalities in vital signs or routine laboratory parameters

Where it is running

• GSK Investigational Site — Chula Vista, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.