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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
Research Site
Helsinki, Finland
Research Site
Pisa, Italy
Research Site
Oxford, United Kingdom
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.
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