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

NCT00551564 | Completed Phase 1

• 1 other identifier: DIX110434
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

total body water; T2DM,; Healthy Obese,; Insulin Resistance,; Rosiglitazone maleate,; Glucose Disposal,; hyperinsulinemic-euglycemic clamp,

Outcome Measures

Primary Outcomes (1)

• Insulin resistance

  baseline and after 8 weeks of Rosiglitazone treatment

Secondary Outcomes (3)

• Insulin resistance

  baseline, after 2 weeks treatment, 2 weeks after discontinuation treatment

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

  baseline, after 8 weeks treatment

• Body composition

  baseline & after 8 weeks treatment

Study Arms (2)

Subjects in healthy normal and overweight control arm

EXPERIMENTAL

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

Drug: rosiglitazone maleate

Subjects in healthy obese with T2DM arm

EXPERIMENTAL

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.

Drug: rosiglitazone maleate

Interventions

rosiglitazone maleate DRUG

Rosiglitazone tablets 4 mg dose will be administered orally by subjects

Subjects in healthy normal and overweight control arm; Subjects in healthy obese with T2DM arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Clinically significant past or current medical conditions
• Clinically significant abnormalities in vital signs or routine laboratory parameters

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Chula Vista, California, 91911, United States

Location

Related Publications (1)

• This study has not been published in the scientific literature.

  BACKGROUND

Related Links

• Results for study DIX110434 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 31, 2007
• Study Start: July 31, 2007
• Primary Completion: September 8, 2008
• Study Completion: September 8, 2008
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)