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

Diabetes Mellitus, Type 2 Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551564
• Other study ID #: DIX110434
• Status: Completed
• Phase: Phase 1
• First received: October 29, 2007
• Last updated: August 2, 2017
• Start date: July 31, 2007
• Est. completion date: September 8, 2008

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 8, 2008
• Est. primary completion date: September 8, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• rosiglitazone maleate
Rosiglitazone tablets 4 mg dose will be administered orally by subjects

Locations

Country	Name	City	State
United States	GSK Investigational Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance		baseline and after 8 weeks of Rosiglitazone treatment
Secondary	Insulin resistance		baseline, after 2 weeks treatment, 2 weeks after discontinuation treatment
Secondary	hepatic glucose output: baseline, after 8 weeks treatment Insulin secretion from oral glucose tolerance		baseline, after 8 weeks treatment
Secondary	Body composition		baseline & after 8 weeks treatment

External Links

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