Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes
Brief summary
This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week double blind treatment period and a 3-week follow-up period.
Interventions
DRUGGalida
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 ³18 years of age * Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control * Diagnosed with type 2 diabetes * Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) | — |
Secondary
| Measure | Time frame |
|---|---|
| Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model | — |
| Lipid parameters | — |
| FPG, homeostasis assessment model, insulin, proinsulin, C-peptide | — |
| Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values | — |
| The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide | — |
| Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination | — |
| Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36) | — |
| Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only). | — |
| Pharmacokinetics of tesaglitazar | — |
Countries
Argentina, Brazil, Canada, Finland, Mexico, Norway, United Kingdom, United States
Outcome results
None listed