A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy when Added to the Therapy of Patients with Type 2 Diabetes Poorly Controlled on Sulphonylurea Alone
- Conditions
- Patients diagnosed with type 2 diabetes and treated with a single or multiple oral antidiabetic agentsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2004-001144-71-ES
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 555
Inclusion criteria at enrolment (visit 1): 1. Provision of a written informed consent at visit 1. 2. Men or women who are older than or 18 years of age at time of consenting upon visit 1. 3. Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable 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. Reliable birth control is defined as double barrier method (condom 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 methods (oral, transdermal, vaginal ring or combination injectables) must agree to use an additional barrier method for contraception (condom or diaphragm). 4. Diagnosed with type 2 diabetes. 5. Treated with a single or multiple oral antidiabetic agents. Inclusion criteria at start of sulphonylurea titration (visit 2, lab values from visit 1): 6. HbA1c higher than or equal to 7% if previously on monotherapy. 7. HbA1c lower than or equal to 10%. 8. FPG lower than or equal to 13.3 mmol/L (240 mg/dL). Inclusion criteria at randomization (visit 7, lab values from visits 5 and 6): 9. Predefined daily dose of sulphonylurea: glibenclamide 10?15 mg, gliclazide 160 320 mg, glimepiride 3-6 mg or glipizide 10-20 mg. 10. HbA1c higher than or equal to 7% and lower than or equal to 10% (laboratory value from visit 6). 11. Mean FPG of two measurements (laboratory values from visit 5 and 6) higher than or equal to 7.0 mmol/L (126 mg/dL) and lower than or equal to 11.7 mmol/L (210 mg/dL).
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 9999
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9999
Exclusion criteria at enrolment (visit 1): 1. Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes. 2. 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. 3. NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator. 4. History of thyroid ophthalmopathy. 5. History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma. 6. History of blood lipid induced eruptive xanthomas or hypertriglyceridaemia induced pancreatitis. 7. Pregnant or breastfeeding patients. 8. Suspicion that the patient is infected according to World Health Organisation (WHO) risk categories 2 to 4. 9. Treatment with chronic insulin, within 24 weeks prior to visit 1 (however, one temporary period of daily insulin injections no longer than 7 days is allowed). 10. Treatment with a thiazolidinedione within 4 weeks prior to visit 1. 11. Treatment with fibrates, within 4 weeks prior to visit 1. 12. Treatment with glucocorticoids (equivalent to oral prednisolon >10 mg per day), within 4 weeks prior to visit 1. 13. Treatment with probenecid that can not be stopped at visit 1. 14. History of hypersensitivity or intolerance to any PPAR agonist. 15. Intolerance to sulphonylurea at any time in the past, or pre-existing medical conditions that is contraindicated for the use of sulphonylurea. 16. History of drug-induced myopathy or drug-induced CK elevation. 17. History of drug-induced liver enzyme elevations. 18. History of drug-induced neutropenia. 19. History of alcohol or drug abuse within the last 5 years. 20. Other serious or unstable medical or psychological condition identified in the patients? medical history that, in the judgement of the investigator, would compromise the patients? safety or successful participation in the Clinical Study. 21. Receiving any investigational product within 12 weeks (90 days for UK) prior to visit 1. 22. Previous enrolment in this study. Exclusion criteria at start of sulphonylurea titration (visit 2, lab values from visit 1): 23. Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgement of the investigator would compromise the patients? safety or successful participation in the Clinical Study. 24. NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator. 25. Fasting TG higher than 7.0 mmol/L (620) mg/dL. 26. Hb lower than 90 g/L (9 g/dL). 27. ANC lower than 1.0 x 10E9/L. 28. Any of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) more than 2.5 times the upper limit of normal. 29. Total bilirubin above the upper limit of normal unless exclusively caused by Gilbert?s syndrome. 30. Creatinine more than 2 times the upper limit of normal. 31. CK more than 3 times the upper limit of normal. Exclusion criteria at randomization (visit 7, lab values from visit 6): 32. Any clinically significant abnormality identified on physical examinations, laboratory tests or ECG, which in the judgement of the investigator would compromise the patients? safety or successful participation in the Clinical Study. 33. NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator. 34. Other
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method