Type II Diabetes Mellitus MedDRA version: 7 Level: LLT Classification code 10045242
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provision of a written informed consent at visit 1 2.Men and women with type 2 diabetes who have completed the last two visits of randomized treatment period in GALLANT 2, 5, 7, 8 and 14 studies 3.Female patients must be post menopausal, hysterectomised or if of childbearing potential using a highly effective method of birth control. Post menopausal patients are defined as patients with: -natural or induced menopause with last menstruation >1 year ago or -bilateral oophorectomy Highly effective birth control is defined as: -double-barrier method (condoms with spermicide, diaphragm with spermicide), -oral contraceptive, implant, long term injectable contraceptive, -intrauterine device, or -tubal ligation. However, female patients using oestrogen containing hormonal anti conception method (oral, transdermal, vaginal ring or combination injectables) must agree to use an additional barrier method for contraception (condom or diaphragm). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes - NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator. For definitions see Appendix F. - History of thyroid ophthalmopathy - History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma - History of blood lipid induced eruptive xanthomas or hypertriglyceridemia induced pancreatitis - Suspicion that the patient is infected according to World Health Organisation (WHO) risk categories 2 to 4. See Appendix G. - History of statin-induced myopathy or statin-induced CK elevation - History of alcohol or drug abuse within the last 5 years - Patient currently in any of the handling plans at the end of randomized treatment visit in the GALLANT 2, 5, 7, 8 or 14 studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to monitor long-term safety and tolerability of tesaglitazar 1 mg, with or without other oral antidiabetic drugs, when administered up to 104 weeks in an extension study from the GALLANT 2, 5, 7, 8 and 14 studies in patients with type 2 diabetes by evaluation of adverse events (AEs), laboratory variables, physical examination, cardiac evaluation, hypoglycaemic events, electrocardiogram (ECG), vital signs (blood pressure (BP) and pulse) and body weight.;Secondary Objective: To evaluate the effect of tesaglitazar 1 mg, with or without other oral antidiabetic drugs, when administered up to 104 weeks in an extension study from the GALLANT 2, 5, 7, 8 and 14 studies in patients with type 2 diabetes: - in modifying glycaemic control (Changes in glycaemic variables: fasting plasma glucose (FPG) and glycosylated haemoglobin A1c (HbA1c)) - in modifying lipid control (Changes in lipid variables (triglycerides (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), 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 TG, TC, LDL-C, HDL-C and non-HDL-C) - on an inflammatory marker (C-Reactive Protein (CRP)) - on central obesity (Waist circumference, Hip circumference, Waist-hip ratio) ;Primary end point(s): There are no endpoint. Please see primary and secondary objectives. | — |
Countries
Czech Republic, Estonia, Finland, Hungary, Latvia, Lithuania, United Kingdom
Outcome results
None listed