A Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long Term Extension Study to Evaluate the Safety and Tolerability of oral Tesaglitazar Therapy in Patients with Type 2 Diabetes Mellit...

Update Il y a 4 ans
Reference: EUCTR2004-005243-97

A Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long Term Extension Study to Evaluate the Safety and Tolerability of oral Tesaglitazar Therapy in Patients with Type 2 Diabetes Mellitus (GALLEX 4)

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Extract

The primary objective of this study is to monitor the long-term safety and tolerability of tesaglitazar (0.5-1 mg) versus glibenclamide (2.5-15 mg), with or without other oral anti-diabetic drugs, when administered for up to 100 weeks in an extension study from the GALLANT 4 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), body weight and height


Inclusion criteria

  • type II diabetes mellitus