Clinical trial NCT00263965: ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-12-12
Enrollment: 105
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are 30-70 years of age
* Female patients: postmenopausal, hysterectomized
* Diagnosed with type 2 diabetes
* Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Received any investigational product in other clinical studies within 12 weeks
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study

Primary outcomes:
measure: Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
Secondary outcomes:
measure: Hepatic and peripheral insulin sensitivity by assessing the M value during low (20 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
measure: Basal hepatic glucose output measured by dideuterated glucose in the fasting state and during low insulin level clamp.
measure: Plasma profile of glucose, insulin and lipids after a mixed meal
measure: Calculated insulin secretion
measure: Liver oxidation after a mixed meal
measure: Energy expenditure and substrate metabolism by indirect calorimetry
measure: Body composition using DXA-scan, abdominal fat distribution using magnetic resonance imaging, liver fat and muscle fat content using magnetic resonance spectroscopy
measure: Waist and hip circumference
measure: Laboratory efficacy variables (lipids, inflammatory marker and adipose tissue hormones)
measure: Safety and tolerability of tesaglitazar in patients with type 2 diabetes.
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: