A multinational, multicenter, post-authorization, prospective observational cohort study to assess the profile of vildagliptin and the fixed-dose combination of vildagliptin/metformin relative to comparator oral anti-diabetic drugs in patients with type 2 diabetes in a real-world setting
Titel der Studie/Acronym
A multinational, multicenter, post-authorization, prospective observational cohort study to assess the profile of vildagliptin and the fixed-dose combination of vildagliptin/metformin relative to comparator oral anti-diabetic drugs in patients with type 2 diabetes in a real-world setting
Zielsetzung/Fragestellung
To assess the proportion of patients on vildagliptin add-on dual therapy or vildagliptin/metformin (fixed-dose) relative to comparator OAD dual therapy in a real-world setting, responding to treatment (defined as decrease in HbA1c 0.3% from baseline) without any of the following adverse effects: peripheral edema or hypoglycemic events or discontinuation due to gastrointestinal events or significant weight gain after 12 months of treatment (see Section 6.3.1 for definition of treatment response).
Indikation
- Diabetes mellitus Typ 2
Wirkstoff
- vildagliptin (deutsch)
Handelsname(n)
Galvus, Eucreas
Geplante Anzahl vorgesehener Studienzentren: für die Untersuchung insgesamt
2000
Geplante Patientenzahl: für die Untersuchung insgesamt
30000
Kontaktperson
Müller, Alfons
Phase IV Manager NIS
Novartis Pharma GmbH
Roonstr. 25
90429 Nürnberg
Deutschland
Telefon: 0911/273-12897
Telefax: 0911/273-15897
Unternehmen
Novartis Pharma GmbH
Roonstr. 25
90429 Nürnberg
Deutschland
Stand der Information
16.11.2012
Status der Studie
Studie bereits abgeschlossen
