WHO ICTRP trial

Evaluate Efficacy and Safety of Saxagliptin in Adult Indian Patients with Type 2…

CTRI/2009/091/000217 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2009/091/000217
Public title Evaluate Efficacy and Safety of Saxagliptin in Adult Indian Patients with Type 2 Diabetes inadequate glycemic control.
Scientific title A 24-Week National, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase IIIb study in India to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control with Diet and Exercise.
Primary sponsor AstraZeneca AB
Secondary sponsors Collaborator BristolMyers Squibb
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 3
Countries India
Conditions Health Condition 1: null- Type 2 Diabetes Health Condition 2: E119- Type 2 diabetes mellitus without complications
Interventions Intervention1: saxagliptin: Plain, yellow, biconvex, round,film coated. Treatment is planned for 24 weeks Control Intervention1: Placebo: Plain,yellow,biconvex,round,film coated tablet to match saxagliptin
Registration date May 29, 2009
Target size 213
Secondary IDs D1680C00008
Registry page ctri.nic.in

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