Information for healthcare professionals
Ozempic®. For adults with type 2 diabetes to improve glycemic control, when diet and exercise plus maximal tolerated metformin dose alone do not achieve adequate glycemic control.
1. Ozempic® Product Monograph. Mississauga, Ontario; Novo Nordisk Canada Inc.; 5 November 2018.
2. Pratley RE, et al. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol 2018. Published online January 31, 2018. http://dx.doi.org/10.1016/S2213-8587(18)30024-X
The SUSTAIN 2 trial was a 56-week, randomized, double-blind, double-dummy, active-controlled, parallel-group trial in which 1,231 patients were randomized 2:2:1:1 to Ozempic® 0.5 mg/Januvia® placebo, Ozempic® 1 mg/Januvia® placebo, Januvia®/Ozempic® 0.5 mg placebo or Januvia®/Ozempic® 1 mg placebo, all in combination with metformin (94%) and/or TZD (6%). Subjects continued pre-trial background medication throughout the entire trial. The primary objective was to compare the effect of once weekly dosing of 2 dose levels of Ozempic® vs. Januvia® 100 mg once daily on glycemic control after 56 weeks of treatment.
The SUSTAIN 7 trial was an open-label, parallel-group, phase 3b trial done at 194 hospitals, clinical institutions or private practices in 16 countries. Eligible patients were aged 18 years or older and had type 2 diabetes with A1C 7.0–10.5% (53.0–91.0 mmol/mol) on metformin monotherapy. Patients were randomly assigned (1:1:1:1) by use of an interactive web-response system to once-a-week treatment with either Ozempic® 0.5 mg, Trulicity® 0.75 mg, Ozempic® 1 mg or Trulicity® 1.5 mg subcutaneously. The primary endpoint was change from baseline in percentage A1C; the confirmatory secondary endpoint was change in bodyweight, both at week 40. The trial was powered for A1C non-inferiority (margin 0.4%) and bodyweight superiority.