Brian Truong Journal Club Write up.docx - Brian-Huy Minh...

This preview shows page 1 - 2 out of 4 pages.

Brian-Huy Minh Truong T00629762 PHAR 442 GENERAL STUDY OVERVIEW Title Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial Citation Lancet Diabetes Endocrinol 2017;5: 341–54 Journal Background Lancet Diabetes & Endocrinol Funding Novo Nordisk Study Background Semaglutide (Ozempic®) is a novel glucagon-like peptide-1 (GLP-1) analogue, suitable for once-weekly subcutaneous administration, in development for treatment of type 2 diabetes. We assessed the efficacy and safety of semaglutide versus the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin(Januvia®) in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both. Trial design 56-week, phase 3a, randomised, double-blind, double-dummy, active-controlled, parallel-group, multinational, multicentre trial (SUSTAIN 2) at 128 sites in 18 countries. Objectives The study was conducted to determine the efficacy and safety of semaglutide versus sitagliptin as an add on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes. Hypothesis Semaglutide would be non-inferior and/or superior to sitagliptin with regard to primary and secondary outcomes. Enrollment Conducted at 128 sites in 18 countries from December 02, 2013 to October 12, 2015 METHODS Patient selection Inclusion criteria: Age 18 years or older (or age 20 years or older in Japan)

  • Left Quote Icon

    Student Picture

  • Left Quote Icon

    Student Picture

  • Left Quote Icon

    Student Picture