ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity
|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)|
|Estimated 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|
|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.
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|