GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
Phase 3
Terminated
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00226330
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adverse events Laboratory variables Physical examination Cardiac evaluation Hypoglycemic events Electrocardiogram Vital signs (blood pressure and pulse) Body weight
- Secondary Outcome Measures
Name Time Method Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C) Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C C-reactive protein (CRP) Central obesity (waist circumference, hip circumference, waist/hip ratio) Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
Trial Locations
- Locations (1)
Research Site
🇬🇧Wiltshire, United Kingdom