E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type II Diabetes Mellitus |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 2/22, 5, 7, 8 and 14 studies in patients with type 2 diabetes by evaluation of AEs, laboratory variables, physical examination, cardiac evaluation, hypoglycaemic events, electrocardiogram (ECG), vital signs (blood pressure (BP) and pulse) and body weight. |
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E.2.2 | Secondary objectives of the trial |
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 2/22, 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)
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 2/22, 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).
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E.4 | Principal 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 2/22, 5, 7, 8 or 14 studies
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E.5 End points |
E.5.1 | Primary end point(s) |
The main analysis set will be the safety population. Patients included in the safety population are all patients having received one dose of tesaglitazar treatment and for whom post-dose data is available. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of study is defined as date of database lock, which is the time point after which no patient will be exposed to study related activities. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |