Dose Response Study in Japanese Patients

AstraZeneca

Status and phase

Terminated

Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: Tesaglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT00261417

D6160L00001

SH-SBD-0013

Details and patient eligibility

About

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.

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of a written informed consent
Men or women who are >=18 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 anti-diabetic 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