View data from a trial comparing Ozempic® (semaglutide) and Januvia® (sitagliptin), both with metformin, over 56 weeks
Ozempic® is indicated for the once-weekly treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with: diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance; metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control; metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control; basal insulin with metformin, when diet and exercise plus basal insulin with metformin do not achieve adequate glycemic control.
Ozempic® is indicated for the once-weekly treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with: diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance; metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control; metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control; basal insulin with metformin, when diet and exercise plus basal insulin with metformin do not achieve adequate glycemic control.
Up to -1.5% A1C reduction demonstrated with Ozempic® + MET (baseline A1C: 8.0%)1,2
At 56 weeks, patients on Ozempic® 0.5 mg once-weekly saw a 1.3% reduction in A1C and those on Ozempic® 1 mg once-weekly experienced a 1.5% reduction (both groups n=409, baseline 8.0%; p<0.0001) compared with patients on Januvia® 100 mg who saw a 0.7% reduction (n=407, baseline 8.2%). Both Ozempic® 0.5 mg and Ozempic® 1 mg showed statistically significant reductions versus Januvia®.1
Up to -5.5 kg weight reduction demonstrated with Ozempic® + MET (baseline weight: 89.2 kg; 2° endpoint)1,2
Patients on Ozempic® 0.5 mg once-weekly demonstrated weight change of -4.2 kg (baseline 89.9 kg) while patients on Ozempic® 1 mg demonstrated weight change of -5.5 kg (baseline 89.2 kg). Patients on Januvia® 100 mg demonstrated weight change of -1.7 kg (baseline 89.3 kg).1 (Ozempic® is not indicated for weight reduction)
HR: 0.74 – demonstrated relative risk of Major Adverse CV Event (safety endpoint) with
Ozempic® + Standard of Care (95% CI: 0.58–0.95; -26%) vs. Placebo1,3
At 2 years, the primary outcome of MACE occurred in 6.6% in the Ozempic® group (n=1,648) vs. 8.9% in the placebo group (n=1,649).1,3 Ozempic® is not indicated to reduce the incidence of CV (MACE) outcomes.1,3
Clinical use:
Not a substitute for insulin. Not for use in type 1 diabetes or for the treatment of diabetic
ketoacidosis. Ozempic® is not indicated for use in pediatric patients.
Contraindications:
- Personal or family history of medullary thyroid carcinoma (MTC), or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Pregnancy or breastfeeding
Most serious warnings and precautions:
Risk of thyroid C-cell tumours: In both genders of rats and mice, semaglutide causes treatment-dependent thyroid C-cell tumours. Patients should be counselled regarding the risk and symptoms of thyroid tumours.
Other relevant warnings and precautions:
Risk of thyroid C-cell tumours: In both genders of rats and mice, semaglutide causes treatment-dependent thyroid C-cell tumours. Patients should be counselled regarding the risk and symptoms of thyroid tumours.
Other relevant warnings and precautions:
- Should not be administered intramuscularly
- Pancreatitis
- Hypoglycemia with concomitant use of insulin secretagogues or insulin
- Use with other incretin drugs
- Hypersensitivity
- Diabetic retinopathy: in patients with history of disease monitor for progression
- Renal impairment: severe GI adverse reactions warrant monitoring of renal function; not recommended in end-stage renal disease
- CV effects: increased heart rate; PR interval prolongation
- Caution in patients with hepatic insufficiency
For more information:
Please consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for more information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this advertisement.
The Product Monograph is also available by calling us at 1-800-465-4334.
CI=confidence interval; CV=cardiovascular; GLP-1 RA=glucagon-like peptide-1 receptor agonist; HR=hazard ratio; MACE=major adverse cardiovascular event; MET=metformin; T2DM=type 2 diabetes mellitus.
References:
- Ozempic® Product Monograph. Mississauga, Ontario; Novo Nordisk Canada Inc.; 5 November 2018.
- Ahrén B, Masmiquel L, Kumar H, et al. 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. Lancet Diabetes Endocrinol. 2017;5(5):341–354. The SUSTAIN 2 trial was a 56-week randomized, double-blind double-dummy, active-controlled, parallel-group trial, 1231 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® 1.0 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.
- Marso SP, et al. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016;375(19):1834-1844. A 2-year, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate CV and other long-term outcomes of Ozempic®. A total of 3,297 with T2DM and high risk of CV events were randomized based on evidence of CV disease, insulin treatment and renal impairment to once-weekly Ozempic® 0.5 mg (n=826), Ozempic® 1 mg (n=822) or placebo (n=1,649) in addition to standard of care treatments such as oral antihyperglycemic treatments, insulin, antihypertensives, diuretics and lipid-lowering therapies at investigator discretion. The primary endpoint was time from randomization to first occurrence of a major adverse CV event (MACE) defined as CV death, non-fatal myocardial infarction, or non-fatal stroke.
