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OpenTrials
Completed

NCT Number: NCT00551564

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

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Chula Vista, California, 91911, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone maleate

Drug

Rosiglitazone tablets 4 mg dose will be administered orally by subjects

Primary outcomes

  1. Insulin resistance

    Time frame: baseline and after 8 weeks of Rosiglitazone treatment

Secondary outcomes

  1. Insulin resistance

    Time frame: baseline, after 2 weeks treatment, 2 weeks after discontinuation treatment

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

    Time frame: baseline, after 8 weeks treatment

  3. Body composition

    Time frame: baseline & after 8 weeks treatment

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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)

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 31, 2007
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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