Last updated: 11/04/2018 06:10:55
Study to Determine the Utility of Novel Technologies and Biomarkers to Measure Human Response to Rosiglitazone Maleate
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial 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.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Insulin resistance
Timeframe: baseline and after 8 weeks of Rosiglitazone treatment
Secondary outcomes:
Insulin resistance
Timeframe: baseline, after 2 weeks treatment, 2 weeks after discontinuation treatment
hepatic glucose output: baseline, after 8 weeks treatment Insulin secretion from oral glucose tolerance
Timeframe: baseline, after 8 weeks treatment
Body composition
Timeframe: baseline & after 8 weeks treatment
Interventions:
Drug: rosiglitazone maleate
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
July 2007 to September 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- 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.
- Clinically significant past or current medical conditions
- Clinically significant abnormalities in vital signs or routine laboratory parameters
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Chula Vista, California, United States, 91911
Status
Will Be Recruiting
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-08-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study DIX110434 can be found on the GSK Clinical Study Register.
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