Semaglutide

(Ozempic®)

Semaglutide

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Drug updated on 5/17/2024

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.

Summary
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  • Semaglutide (Ozempic) is recommended alongside diet and exercise to enhance glycemic control in adults with type 2 diabetes mellitus, and it also lowers the risk of significant adverse cardiovascular events in these patients with established cardiovascular disease.
  • The analysis on semaglutide incorporated a total of 18 systematic reviews or meta-analyses.
  • Semaglutide has proven highly effective in decreasing HbA1c levels and body weight compared to placebo and several other antidiabetic agents, including DPP-4 inhibitors, SGLT-2 inhibitors, and other GLP-1 receptor agonists, across various patient populations.
  • It has shown positive effects in reducing major adverse cardiovascular events (MACE), especially among high-risk patients with type 2 diabetes when compared to placebo. This effect remained consistent across subgroup analyses, highlighting its favorable safety profile in terms of cardiovascular health.
  • Emerging studies suggest that GLP-RAs like semaglutide might lessen neurological complications associated with diabetes such as stroke or cognitive impairments, though further investigation is necessary.
  • Compared to other GLP-RAs like dulaglutide and liraglutide, particularly at higher doses, indirect treatment comparisons have demonstrated the superior efficacy of semaglutide in both glycemic control and weight reduction.
  • Semaglutide's safety profile is consistent with the effects observed within the class of GLP-RAs, showing no significant increase in severe hypoglycemia, pancreatitis, or pancreatic cancer. However, gastrointestinal side effects were reported, which are common within this class of drugs.
  • Patients with increased cardiovascular risks have shown consistent benefits while using semaglutide alongside metformin therapy, resulting in decreased all-cause mortality rates and improved cardiovascular outcomes. Additionally, Asians have exhibited pronounced benefits from long-acting GLP-1 RA therapy, including semaglutide, although further research is required in this area.

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
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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