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Semaglutide

(Ozempic®)

Ozempic®

Drug updated on 4/9/2024

Dosage FormInjection (subcutaneous; 0.68 mg/mL [0.25 mg or 0.5 mg per injection], 1.34 mg/mL [1 mg per injection], 2.68 mg/mL [2 mg per injection])
Drug ClassGlucagon-like peptide 1 (GLP-1) receptor agonists
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

Summary
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  • Semaglutide (Ozempic) is indicated as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes mellitus, and also for reducing the risk of major adverse cardiovascular events in this patient population with established cardiovascular disease.
  • A total of 17 systematic reviews/meta-analyses were reviewed which provided insights into the safety and effectiveness profile of semaglutide (Ozempic).
  • In terms of safety, semaglutide was generally well-tolerated but associated with gastrointestinal adverse events; however, it did not significantly increase serious adverse events such as severe hypoglycemia, acute pancreatitis or diabetic retinopathy compared to placebo or other active comparators.
  • The drug demonstrated superior efficacy in controlling blood glucose levels by significantly reducing HbA1c levels when compared to a variety of antidiabetic drugs including dulaglutide, exenatide, liraglutide among others.
  • Semaglutide showed significant weight reduction effects especially at higher doses when compared against insulin treatments and SGLT-2 inhibitors like empagliflozin indicating its potential use-case scenario for obese or overweight patients diagnosed with type 2 diabetes mellitus.
  • It has been observed that semaglutide can potentially reduce major adverse cardiovascular events without increasing risks related to severe hypoglycemia or pancreatic conditions making it a viable treatment option even for those patients who have baseline metformin use.
  • Subgroup analysis revealed racial differences where subjects from African origin and Asians experienced more significant risk reductions on long-acting GLP-1 RAs treatment including semglutamide than White subjects suggesting its utility across diverse patient populations within the T2DM spectrum.
  • Overall findings suggest that despite high incidence rates associated with gastrointestinal side-effects, semglutamide's dual efficacy in glycemic control and weight management along with its potential cardiovascular benefits make it a favorable treatment option for type 2 diabetes mellitus.

Product Monograph / Prescribing Information

Document TitleYearSource
Ozempic (semaglutide) Prescribing Information.2023Novo Nordisk Inc., Plainsboro, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Evaluation and comparison of efficacy and safety of tirzepatide and semaglutide in patients with type 2 diabetes mellitus: A Bayesian network meta-analysis2024Pharmacological Research
Efficacy and tolerability of the Subcutaneous Semaglutide for type 2 Diabetes patients: an updated systematic review and meta-analysis2023Diabetology & Metabolic Syndrome
Real-world clinical effectiveness of once-weekly semaglutide in patients with type 2 diabetes: a systematic literature review.2023Expert Review of Clinical Pharmacology
Effects of GLP-1 receptor agonists on neurological complications of diabetes.2023Reviews in Endocrine and Metabolic Disorders
Comparative efficacy and safety of glucagon-like peptide 1 receptor agonists for the treatment of type 2 diabetes: A network meta-analysis.2023Medicine
An Indirect Treatment Comparison of Semaglutide 2.0 mg vs Dulaglutide 3.0 mg and 4.5 mg Using Multilevel Network Meta-regression2022The Journal of Clinical Endocrinology & Metabolism
Semaglutide reduces cardiovascular events regardless of metformin use: a post hoc subgroup analysis of SUSTAIN 6 and PIONEER 6.2022Cardiovascular Diabetology
Semaglutide for the treatment of type 2 Diabetes Mellitus: a systematic review and network meta-analysis of safety and efficacy outcomes.2022Diabetes & Metabolic Syndrome: Clinical Research & Reviews
The efficacy and safety of oral semaglutide for glycaemic management in adults with type 2 diabetes compared to subcutaneous semaglutide, placebo, and other GLP-1 RA comparators: A systematic review and network meta-analysis.2022Contemporary Clinical Trials Communications
Once-daily oral semaglutide versus injectable glp-1 RAs in people with type 2 diabetes inadequately controlled on basal insulin: systematic review and network meta-analysis.2021Diabetes Therapy
Comparative efficacy and safety of 8 GLP-1RAs in patients with type 2 diabetes: A network meta-analysis.2021Diabetes Research and Clinical Practice
Comparative Effectiveness of Glucose-Lowering Drugs for Type 2 Diabetes: A Systematic Review and Network Meta-analysis.2020Annals of Internal Medicine
Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis.2020The Journal of Clinical Endocrinology & Metabolism
Comparative efficacy of once-weekly semaglutide versus SGLT-2 inhibitors in patients inadequately controlled with one to two oral antidiabetic drugs: a systematic literature review and network meta-analysis2019BMJ Open
Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials.2019The Lancet Diabetes & Endocrinology
Comparing once-weekly semaglutide to incretin-based therapies in patients with type 2 diabetes: a systematic review and meta-analysis2019Diabetes & Metabolism
Asian Subpopulations May Exhibit Greater Cardiovascular Benefit from Long-Acting Glucagon-Like Peptide 1 Receptor Agonists: A Meta-Analysis of Cardiovascular Outcome Trials.2019Diabetes & Metabolism Journal

Clinical Practice Guidelines

Document TitleYearSource
SGLT-2 inhibitors or GLP-1 receptor agonists for adults with type 2 diabetes: a clinical practice guideline.2021British Medical Journal
Clinical Management of Stable Coronary Artery Disease in Patients With Type 2 Diabetes Mellitus: A Scientific Statement From the American Heart Association.2020Circulation