GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus

AstraZeneca

Status and phase

Terminated

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Pioglitazone

Drug: Tesaglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT00226330

D6160C00048

Details and patient eligibility

About

This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.

Sex

All

Ages

18+ 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; or, if of childbearing potential, using a reliable method of birth control.
Completed the last two visits of the randomized treatment period in GALLANT 6

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, or neutropenia (low white blood cells)
Creatinine levels of above twice the normal range
Creatine kinase of above 3 times the upper limit of normal
Previous enrollment in this long-term extension study
Any clinically significant abnormality identified by 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