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

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

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)

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).

total body water, T2DM,, Healthy Obese,, Insulin Resistance,, Rosiglitazone maleate,, Glucose Disposal,, hyperinsulinemic-euglycemic clamp,

Subjects in the Healthy Normal or Overweight Control Population will be included in this arm and they will receive Rosiglitazone 4 milligram twice daily.

Subjects who are in the Healthy Obese or T2DM Population will be included in this arm and they will receive Rosiglitazone 4 milligram twice daily.

hepatic glucose output: baseline, after 8 weeks treatment Insulin secretion from oral glucose tolerance

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

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.