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.
A Single-Center, Non-Randomized, Open-Label, Comparative Study to Assess the Utility of Novel
Technologies and Biomarkers as Methods for Measuring Human Pharmacodynamic Response to 8
Weeks of Administration of Rosiglitazone Maleate 4mg BID in Healthy Normal or Overweight
Controls, Healthy Obese Subjects and Subjects with Type 2 Diabetes Mellitus (T2DM).
- 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
- Clinically significant past or current medical conditions
- Clinically significant abnormalities in vital signs or routine laboratory parameters