Diabetes Mellitus, Type 2
Conditions
Keywords
Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 6.
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.
Interventions
DRUGTesaglitazar
(0.5 or 1 mg)
DRUGPioglitazone
(15, 30 or 45 mg)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight | — |
| Laboratory variables | — |
| Physical examination | — |
| Cardiac evaluation | — |
| Hypoglycemic events | — |
| Electrocardiogram | — |
| Vital signs (blood pressure and pulse) | — |
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
| Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c | — |
Countries
Argentina, Brazil, Canada, Finland, Mexico, United Kingdom, United States
Outcome results
None listed