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

NCT00551564 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-08-04

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

rosiglitazone maleate

Rosiglitazone tablets 4 mg dose will be administered orally by subjects

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00551564 on ClinicalTrials.gov