Type 2 Diabetes
Conditions
Brief summary
This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.
Interventions
DRUGtesaglitazar
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 randomized treatment period in GALLANT 2/22, 5, 7, 8 or 14 studies.
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 * Previous enrollment in this long-term extension study * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c, lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol) | — |
| Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol | — |
| C-reactive protein | — |
| Central obesity (waist circumference, hip circumference, waist/hip ratio) | — |
Countries
Argentina, Australia, Brazil, Canada, Czechia, Estonia, Finland, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Latvia, Lithuania, Malaysia, Netherlands, Philippines, Poland, Portugal, Russia, Serbia and Montenegro, Singapore, Slovakia, South Africa, South Korea, Switzerland, United Kingdom, United States, Vietnam
Outcome results
None listed