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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00551564 |
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.
Condition | Intervention | Phase |
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Healthy Subjects Obesity Type 2 Diabetes Mellitus |
Drug: rosiglitazone maleate |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 36 |
Study Start Date: | July 2007 |
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).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | DIX110434 |
Study First Received: | October 29, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00551564 |
Health Authority: | United States: Food and Drug Administration |
hyperinsulinemic-euglycemic clamp, total body water Insulin Resistance, T2DM, |
Healthy Obese, Rosiglitazone maleate, Glucose Disposal, |
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Healthy Insulin Body Weight Signs and Symptoms |
Maleic acid Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Rosiglitazone |
Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions |