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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00551564
First received: October 29, 2007
Last updated: October 14, 2010
Last verified: October 2010
History of Changes

October 29, 2007
October 14, 2010
July 2007
September 2008   (final data collection date for primary outcome measure)
Insulin resistance [ Time Frame: baseline and after 8 weeks of Rosiglitazone treatment ]
Same as current
Complete list of historical versions of study NCT00551564 on ClinicalTrials.gov Archive Site
  • Insulin resistance [ Time Frame: baseline, after 2 weeks treatment, 2 weeks after discontinuation treatment ]
  • hepatic glucose output: baseline, after 8 weeks treatment Insulin secretion from oral glucose tolerance [ Time Frame: baseline, after 8 weeks treatment ]
  • Body composition [ Time Frame: baseline & after 8 weeks treatment ]
Same as current
Not Provided
Not Provided
 
Study to Determine the Utility of Novel Technologies and Biomarkers to Measure Human Response to Rosiglitazone Maleate
See Detailed Description

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).
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Healthy Subjects
  • Obesity
  • Type 2 Diabetes Mellitus
Drug: rosiglitazone maleate
Other Name: rosiglitazone maleate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00551564
DIX110434
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP