A Long-Term, Post treatment, Safety Follow-up, Multi-Centre Study in Patients with Type 2 Diabetes Mellitus from the GALLANT, GALLEX or ARMOR Studies, G-PLUS (GALLANT, GALLEX and ARMOR - Post treatmen...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-001373-97

A Long-Term, Post treatment, Safety Follow-up, Multi-Centre Study in Patients with Type 2 Diabetes Mellitus from the GALLANT, GALLEX or ARMOR Studies, G-PLUS (GALLANT, GALLEX and ARMOR - Post treatment Long-term follow-Up Study)

Femme et Homme

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Extrait

To investigate post treatment safety of patients with type 2 diabetes, who received randomized treatment in any of the treatment studies GALLANT, GALLEX or ARMOR by: 1. evaluating medical events and physical examination at 6 months post treatment in patients who received treatment for at least 24 weeks in the treatment study or discontinued due to presence of pre-defined labaratory or clinical findings 2. evaluating 12 weeks post treatment laboratory safety data, adverse events, physical examination and weight in patients who completed a GALLANT study in countries not participating in any of the GALLEX studies 3. evaluating 12 weeks post treatment laboratory safety data, adverse events, cardiac evaluation, physical examination and weight in patients with pre-defined laboratory or clinical findings


Critère d'inclusion

  • type II diabetes mellitus