Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type II, Type 2 Diabetes Mellitus
Brief summary
This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment and follow-up, is 143 weeks.
Interventions
DRUGTesaglitazar
0.5 in combination with insulin (with or without other oral antidiabetic drugs)
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 the randomized treatment period in GALLANT 9
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 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 |
|---|---|
| Body weight | — |
| Physical examination | — |
| Cardiac evaluation | — |
| Hypoglycemic events | — |
| Electrocardiogram | — |
| Vital signs (blood pressure and pulse) | — |
| Adverse events | — |
| Laboratory variables | — |
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) | — |
| Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c | — |
Countries
United States
Outcome results
None listed