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.

Registry ID

EUCTR2004-002549-11

Source registry

EUCTR

Status

Completed

Phase

PHASE3

Sponsor

AstraZeneca AB

Start date

2005-06-20

Completion date

2007-02-28

Last update

2026-08-16

Conditions

• Type II Diabetes Mellitus

Summary

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, 5, 7, 8 and 14 studies 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) and body weight.

Locations

• , , Lithuania
• , , UK
• , , Latvia
• , , Slovakia
• , , Finland
• , , Czechia
• , , Hungary
• , , Estonia

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