WHO ICTRP trial

Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients…

CTRI/2010/091/001276 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2010/091/001276
Public title Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
Scientific title A 24-week, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of vildagliptin 50mg bid as an add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus - NIL
Primary sponsor Novartis HeatlhCare Pvt Ltd
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 3
Countries Australia;Belgium;Czech Republic;Germany;Hungary;India;Romania;Slovakia;United Kingdom
Conditions Health Condition 1: null- Type 2 Diabetes Mellitus
Interventions Intervention1: Vildagliptin: Experimental. Vildagliptin 50 mg tab bid, orally for 24weeks Control Intervention1: Placebo Comparator: Placebo. 501 tab (50mg)bid,given orally for a duration of 24weeks.
Registration date Dec 22, 2010
Target size 428
Secondary IDs CLAF237A23135;NCT01224366
Registry page ctri.nic.in

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