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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-09-08

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subjects in healthy normal and overweight control arm

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

Group Type EXPERIMENTAL

rosiglitazone maleate

Intervention Type DRUG

Rosiglitazone tablets 4 mg dose will be administered orally by subjects

Subjects in healthy obese with T2DM arm

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.

Group Type EXPERIMENTAL

rosiglitazone maleate

Intervention Type DRUG

Rosiglitazone tablets 4 mg dose will be administered orally by subjects

Interventions

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rosiglitazone maleate

Rosiglitazone tablets 4 mg dose will be administered orally by subjects

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Chula Vista, California, United States

Site Status

Countries

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United States

References

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This study has not been published in the scientific literature.

Reference Type BACKGROUND

Study Documents

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