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An Open, Multi-Centre and Long-Term Extension Study to Evaluate the Safety and Tolerability of oral Tesaglitazar therapy 1 mg in patients with Type 2 Diabetes Mellitus. (Protocol Amendment Nr.1, da...

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Reference: EUCTR2004-002549-11

An Open, Multi-Centre and Long-Term Extension Study to Evaluate the Safety and Tolerability of oral Tesaglitazar therapy 1 mg in patients with Type 2 Diabetes Mellitus. (Protocol Amendment Nr.1, date 2005-04-06)

Woman and Man

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Extract

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.

Inclusion criteria

  • type II diabetes mellitus

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