| Trial ID: | L3193 |
| Source ID: | NCT00263965
|
| Associated Drug: |
Tesaglitazar
|
| Title: |
ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Tesaglitazar|DRUG: Metformin|BEHAVIORAL: Dietary and lifestyle modification counseling
|
| Outcome Measures: |
Primary: Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp. | Secondary: 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.
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
105
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-08
|
| Completion Date: |
2006-07
|
| Results First Posted: |
|
| Last Update Posted: |
2008-03-17
|
| Locations: |
Research Site, Helsinki, Finland|Research Site, Pisa, Italy|Research Site, Oxford, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00263965
|
