Semaglutide

Introduction

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for the treatment of type 2 diabetes and obesity. It is available in both subcutaneous and oral formulations and has been the subject of numerous clinical trials to assess its efficacy and safety.

Key Insights

Efficacy in Glycemic Control and Weight Reduction:
- Semaglutide significantly improves glycemic control and reduces body weight in patients with type 2 diabetes, both as monotherapy and in combination with other antidiabetic medications .
- Higher doses of semaglutide (2.4 mg) are more effective for weight management in adults with obesity and type 2 diabetes compared to lower doses and placebo .
Safety Profile:
- The most common adverse events associated with semaglutide are gastrointestinal issues, such as nausea and diarrhea, which are generally mild to moderate and transient .
- Semaglutide has a similar safety profile to other GLP-1 receptor agonists, with no unexpected safety issues identified to date. However, there is an increased risk of biliary disease (cholelithiasis) and potential concerns regarding pancreatic and thyroid cancer, although definitive conclusions cannot be drawn due to low incidence.
Comparative Efficacy:
- Semaglutide is superior to sitagliptin in improving glycemic control and reducing body weight in patients with type 2 diabetes inadequately controlled on metformin or thiazolidinediones.
- In adolescents with obesity, semaglutide significantly reduces BMI and improves cardiometabolic risk factors compared to placebo.
Formulation and Dosing:
- Oral semaglutide is effective in patients with type 2 diabetes and moderate renal impairment, providing a new treatment option for this population.
- The pharmacokinetic profile of oral semaglutide supports once-daily dosing, and it is well-tolerated with a safety profile consistent with the GLP-1 receptor agonist class.

Conclusion

Semaglutide is a highly effective treatment for type 2 diabetes and obesity, offering significant improvements in glycemic control and weight reduction. It has a well-established safety profile, with gastrointestinal issues being the most common adverse events. Semaglutide's efficacy is superior to some other antidiabetic medications, and it is available in both subcutaneous and oral formulations, making it a versatile option for patients with varying needs.

Summary

Introduction

Key Insights

Conclusion

Sources and full results

Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial.

Semaglutide once weekly as an add-on to SGLT-2 inhibitor therapy significantly improves HbA1c levels and bodyweight in patients with inadequately controlled type 2 diabetes.

Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial.

Once-weekly semaglutide monotherapy effectively improves glycemic control in treatment-naive patients with type 2 diabetes, but may cause gastrointestinal adverse events.

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.

Once-weekly semaglutide is more effective and safe than once-daily sitagliptin for improving glycemic control in patients with type 2 diabetes inadequately controlled on metformin, thiazolidinediones, or both.

Safety of Semaglutide

Semaglutide has a favorable risk/benefit profile for type 2 diabetes patients, with mostly mild gastrointestinal disturbances and increased risk of biliary disease, but no unexpected safety issues.

Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial.

Oral semaglutide is effective and safe for patients with type 2 diabetes and moderate renal impairment, improving glucose control and bodyweight reduction.

Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial

Semaglutide 24 mg once a week effectively manages weight in adults with overweight or obesity and type 2 diabetes, with more patients achieving at least 5% weight reduction compared to placebo.

Once-Weekly Semaglutide in Adults with Overweight or Obesity.

Once-weekly semaglutide at 2.4 mg, combined with lifestyle intervention, effectively achieved sustained, clinically relevant weight loss in overweight or obese adults.

Semaglutide as a promising antiobesity drug

Once daily sc semaglutide shows superior weight loss efficacy and no safety concerns, making it a promising future antiobesity drug.

Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes

Oral semaglutide is a safe and well-tolerated GLP-1 analogue suitable for once-daily dosing in healthy and type 2 diabetes patients.

Once-Weekly Semaglutide in Adolescents with Obesity.

Once-weekly semaglutide treatment combined with lifestyle intervention significantly reduced BMI in adolescents with obesity compared to lifestyle intervention alone.

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