ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity

NCT ID: NCT00263965

Last Updated: 2008-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-07-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Tesaglitazar

Intervention Type: DRUG

Metformin

Intervention Type: DRUG

Dietary and lifestyle modification counseling

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

AstraZeneca Galida Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Site

Helsinki, , Finland

Research Site

Pisa, , Italy

Research Site

Oxford, , United Kingdom

Countries

Finland; Italy; United Kingdom

Other Identifiers

EudraCT No 2004-000350-24

Identifier Type: -

Identifier Source: secondary_id

D6160C09999

Identifier Type: -

Identifier Source: org_study_id