drugset / Trial / NCT00261417

Dose Response Study in Japanese Patients

NCT00261417

Phase 2 Terminated 250 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a 12-week study to determine the effect on glucose and lipids, safety, and tolerability of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) compared with placebo in patients with type 2 diabetes. Improvement in dyslipidemia will be evaluated. The study comprises a 2-week screening period, 4-week placebo run-in, a 12-week randomized, double blind, parallel group, multi-center, placebo-controlled treatment period, and a 3-week follow-up.

Timeline

Start
2004-05
Primary completion
Completion
2005-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tesaglitazar Small molecule 0.25 mg
Subject Tesaglitazar Small molecule 0.5 mg
Subject Tesaglitazar Small molecule 0.75 mg
Subject Tesaglitazar Small molecule 1 mg