Semaglutide

(Ozempic®)

Semaglutide

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous; 2 mg/3 mL, 4 mg/3 mL, 8 mg/3 mL)
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.

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Summary
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  • Ozempic (semaglutide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
  • This summary is based on the review of 17 systematic reviews/meta-analyses. [1-17]
  • HbA1c Reduction: Semaglutide (Sem) demonstrated a significant reduction in HbA1c levels, with Sem 0.5 mg and 1.0 mg reducing HbA1c by 0.56% and 0.63%, respectively, compared to other glucose-lowering agents. Tirzepatide (Tir) (5 mg, 10 mg, 15 mg) showed superior HbA1c reduction compared to Sem 1 mg, while Sem 2.0 mg was more effective than Dulaglutide 3.0 mg and 4.5 mg in reducing HbA1c.
  • Body Weight Reduction: Semaglutide consistently resulted in significant weight loss, with Sem 0.5 mg and 1.0 mg reducing body weight significantly more than placebo and other glucose-lowering agents. Tirzepatide demonstrated greater weight reduction than Sem 1 mg, and Sem 2.0 mg was more effective than Dulaglutide 3.0 mg and 4.5 mg in reducing body weight.
  • Cardiovascular Outcomes: Semaglutide reduced major adverse cardiovascular events (MACE) and stroke incidences compared to placebo and other agents, with consistent cardiovascular outcomes observed across different baseline cardiovascular risk profiles.
  • Comparison with Other Drugs: Tirzepatide showed superior efficacy in both HbA1c and weight reduction compared to Semaglutide, while Semaglutide was more effective than Dulaglutide and SGLT-2 inhibitors in these outcomes.
  • Semaglutide was associated with a higher incidence of gastrointestinal-related adverse events, including nausea, diarrhea, and vomiting, particularly at higher doses.
  • There were increased cases of diabetic retinopathy reported with subcutaneous Semaglutide.
  • Semaglutide did not increase the incidence of serious adverse events compared to placebo or other agents.
  • Semaglutide was effective in both GLP-1 RA-naïve and GLP-1 RA-experienced patients, and showed similar cardiovascular outcomes regardless of baseline metformin use, with consistent efficacy across varying cardiovascular risk profiles.

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
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
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
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

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