In patients with type 2 diabetes inadequately managed by diet and exercise alone, once-weekly semaglutide monotherapy significantly reduced HbA1c and body weight compared to placebo, demonstrating a promising safety profile, though with mild-to-moderate gastrointestinal side effects.
PICO Summary
Population:
Treatment-naïve adults with type 2 diabetes (n=388) with a baseline HbA1c of 7.0–10.0%.
Intervention:
Once-weekly subcutaneous semaglutide, 0.5 mg or 1.0 mg, administered over 30 weeks.
Comparison:
Placebo (once-weekly).
Outcome:
- Efficacy: At 30 weeks, semaglutide reduced HbA1c by up to 1.6% and body weight by up to 4.5 kg, significantly outperforming placebo.
- Safety and Tolerability: Primary adverse effects were gastrointestinal, including nausea and vomiting, with discontinuation due to adverse events being low across groups.
Clinical Summary
Main Finding:
Semaglutide monotherapy significantly improved glycaemic control and weight loss compared to placebo in type 2 diabetes patients.
Clinical Relevance:
This study highlights semaglutide’s potential as a monotherapy option, especially suitable for patients preferring non-daily administration and desiring weight management.
Study Overview:
- Type of Study: Randomised, double-blind, placebo-controlled phase 3a trial.
- Sample Size & Population: 388 adults with type 2 diabetes.
- Intervention Duration & Doses: 30-week treatment with semaglutide (0.5 mg or 1.0 mg weekly).
- Comparison: Placebo.
Outcomes:
- Primary Measure (HbA1c): Achieved up to a 1.6% reduction, markedly better than placebo.
- Secondary Measure (Body Weight): Weight loss of up to 4.5 kg with semaglutide, surpassing placebo.
- Safety Profile: Mostly mild to moderate gastrointestinal events, with low discontinuation rates.
Considerations:
Short-term trial duration limits insight into long-term effects; larger studies are needed to confirm findings and refine dosing for optimal efficacy and tolerability.
Reference:
Sorli, C., et al. (2017). The Lancet. Click here.
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.