Overview
GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin
Status:
Terminated
Terminated
Trial end date:
2006-03-01
2006-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AstraZenecaTreatments:
Insulin
Insulin, Globin Zinc
Criteria
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