ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity
This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2 diabetes. After a 1-week enrollment period, a 3 week placebo single blind run in period and 1-week placebo single-blind baseline measurement period, the patients will be given the investigational product for 16 weeks in a double blind fashion. Metformin will be titrated up during the first 3 weeks of the double-blind period. The total study duration, including enrollment, run-in, randomized treatment and follow-up, is 29 weeks.
Type 2 Diabetes
Behavioral: Dietary and lifestyle modification counseling
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- 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.
|Study Start Date:||August 2005|
|Study Completion Date:||July 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263965
|Oxford, United Kingdom|
|Study Director:||AstraZeneca Galida Medical Science Director, MD||AstraZeneca|