Type II Diabetes Mellitus MedDRA version: 7 Level: LLT Classification code 10045242
Conditions
Interventions
Product Name: Tesaglitazar
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tesaglitazar
CAS Number: 251565-85-2
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concen
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria at enrolment (visit 1): 1. Provision of written informed consent 2. Men and women with type 2 diabetes who have completed the Visits 11 and 12 of the randomised treatment period in the GALLANT 6 study. 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 (IUD),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: 1.1.1 Exclusion criteria Any of the following is regarded as a criterion for exclusion from the study: Exclusion criteria at enrolment (visit 1): 1. Any clinically significant abnormality identified on physical examination, laboratory tests or ECG from GALLANT 6 visit 12, which in the judgment of the investigator would compromise the patients’ safety or successful participation in the study 2. Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes 3. Active arterial disease such as unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular accident, myocardial or peripheral vascular disease revascularization or angioplasty within 24 weeks prior to visit 1 4. NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator (Follow local package insert for piogliatzone contraindication, if applicable). For definition, see Appendix F. 5. History of thyroid ophthalmopathy 6. History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma 7. History of blood lipid induced eruptive xanthomas or hypertriglyceridemia induced pancreatitis 8. History of statin-induced myopathy or statin-induced creatine kinase (CK) elevation. 9. Suspicion that the patient is infected according to World Health Organisation (WHO) risk categories 2 to 4. See Appendix G 10. History of alcohol or drug abuse within the last 5 years 11. Patients in any of the handling plans at the end of treatment visit (visit 12) in GALLANT 6 12. Other serious or unstable medical or psychological condition identified in the patient’s medical history that, in the judgment of the investigator, would compromise the patients’ safety or successful participation in the study 13. Previous inclusion in this long term extension study 14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to monitor the long-term safety and tolerability of tesaglitazar (0.5 and 1 mg) versus pioglitazone (15, 30 and 45 mg), with or without other oral anti-diabetic drugs, when administered up to 104weeks in an extension study from the GALLANT 6 study 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 (0.5 and 1 mg) versus pioglitazone (15, 30 and 45 mg), with or without other oral anti-diabetic drugs, when administered up to 104weeks in an extension study from the GALLANT 6 study in patients with type 2 diabetes in modifying glycaemic control by assessment of: -Changes in glycaemic variables: fasting plasma glucose (FPG) glycosylated haemoglobin A1c (HbA1c), insulin and Homeostasis Assessment Model (HOMA) -Changes in lipid variables (triglycerides (TG), total cholesterol (TC), LDL-C, high density lipoprotein-cholesterol (HDL-C), non-HDL-C, ApoB/ApoA-1, ApoCIII, FFA, and Lipoprotein particle size) -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 -inflammatory markers by assessment of C-Reactive protein (CRP). ;Primary end point(s): Safety of patients | — |
Countries
Finland, United Kingdom
Outcome results
None listed