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ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity

NCT00263965 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2008-03-17

No results posted yet for this study

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

Interventions

DRUG

Tesaglitazar

DRUG

Metformin

BEHAVIORAL

Dietary and lifestyle modification counseling

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Galida Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Completion
2006-07-31

Countries

  • Finland
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00263965 on ClinicalTrials.gov