ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00263965|
Recruitment Status : Terminated (The development program has been terminated)
First Posted : December 12, 2005
Last Update Posted : March 17, 2008
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Tesaglitazar Drug: Metformin Behavioral: Dietary and lifestyle modification counseling||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A 16-Week Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo- and Active- (Metformin) Controlled Study to Evaluate the Effect on Whole Body Insulin Sensitivity of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes|
|Study Start Date :||August 2005|
|Actual Study Completion Date :||July 2006|
- Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
- Hepatic and peripheral insulin sensitivity by assessing the M value during low (20 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
- Basal hepatic glucose output measured by dideuterated glucose in the fasting state and during low insulin level clamp.
- Plasma profile of glucose, insulin and lipids after a mixed meal
- Calculated insulin secretion
- Liver oxidation after a mixed meal
- Energy expenditure and substrate metabolism by indirect calorimetry
- Body composition using DXA-scan, abdominal fat distribution using magnetic resonance imaging, liver fat and muscle fat content using magnetic resonance spectroscopy
- Waist and hip circumference
- Laboratory efficacy variables (lipids, inflammatory marker and adipose tissue hormones)
- Safety and tolerability of tesaglitazar in patients with type 2 diabetes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263965
|Oxford, United Kingdom|
|Study Director:||AstraZeneca Galida Medical Science Director, MD||AstraZeneca|