GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin

AstraZeneca

Status and phase

Terminated

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Insulin at least 30 units/day

Drug: Tesaglitazar 0.5

Study type

Interventional

Funder types

Industry

Identifiers

NCT00242372

D6160C00033

Details and patient eligibility

About

This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin (along or in combination with one or more oral antidiabetic agents in addition to diet and lifestyle advice). The study comprises a 3-week enrollment period and a 24-week randomized, double blind, multi-center, placebo-controlled treatment period and a 3-week follow-up. Patients must receive at least 30 units of insulin per day and will continue their current oral antidiabetic treatment regimen throughout the study.

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
Diagnosed with type 2 diabetes for less than 20 years and receiving at least 30 U insulin per day

Exclusion criteria

Type 1 diabetes
New York Heart Association heart failure Class III or IV
Treatment with any thiazolidinedione class of antidiabetic agents
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