An Open-label, Multi-Centre and Long-Term Extension Study to Evaluate the Safety and Tolerability of oral Tesaglitazar 1 mg in patients with Type 2 Diabetes. - GALLEX 1

• Conditions: Type II Diabetes Mellitus; MedDRA version: 7Level: LLTClassification code 10045242

• Registration Number: EUCTR2004-002549-11-FI
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-21
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2100

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified