In patients with type 2 diabetes, oral semaglutide significantly improved HbA1c levels and reduced body weight compared to placebo over 26 weeks, showing comparable efficacy to subcutaneous semaglutide, though associated with mild-to-moderate gastrointestinal side effects.
PICO Summary
Population:
Adults with type 2 diabetes (n=632), aged 18+, inadequately controlled on diet and exercise or metformin.
Intervention:
Once-daily oral semaglutide in various dosages (2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg) with differing escalation rates.
Comparison:
Placebo (oral) and subcutaneous semaglutide (1.0 mg weekly).
Outcome:
- Efficacy: HbA1c reduced by up to 1.9% with oral semaglutide (dose-dependent), similar to the reduction with subcutaneous semaglutide and significantly more than the 0.3% reduction with placebo.
- Safety and Tolerability: Adverse events, primarily gastrointestinal (e.g., nausea), were most common in the semaglutide groups.
Clinical Summary
Main Finding:
Oral semaglutide effectively improved glycaemic control and weight loss in type 2 diabetes patients, with similar efficacy to injectable semaglutide.
Clinical Relevance:
Oral semaglutide offers a promising alternative for glycaemic control, potentially improving adherence for patients who prefer non-injectable options.
Study Overview:
- Type of Study: Phase 2, randomised, parallel-group, dosage-finding trial.
- Sample Size & Population: 632 adults with type 2 diabetes.
- Intervention Duration & Doses: 26 weeks, with oral semaglutide (up to 40 mg daily) vs placebo and subcutaneous semaglutide (1.0 mg weekly).
- Comparison: Placebo and subcutaneous semaglutide.
Outcomes:
- Primary Measure (HbA1c): HbA1c decreased by up to 1.9% with oral semaglutide, comparable to subcutaneous semaglutide and superior to placebo.
- Secondary Measure (Body Weight): Weight loss up to 6.9 kg with oral semaglutide; reductions were dosage-dependent.
- Safety Profile: Most common side effects were gastrointestinal; fewer patients in the placebo group reported side effects.
Considerations:
The study duration limits insights into long-term efficacy and safety. Future studies should assess effects in a broader patient population with more severe baseline HbA1c levels.
Reference:
Davies, M., et al. (2017). JAMA, 318(15), 1460-1470. doi:10.1001/jama.2017.14752
Disclosure: This article on Hormone Insight was created with both human and AI assistance. The human expert editor reviewed the article before publication to ensure accuracy, quality, and clarity.
