In patients with type 2 diabetes on basal insulin, adding semaglutide significantly improved glycaemic control (HbA1c reduction) and weight loss compared to placebo, though it was associated with more gastrointestinal side effects.
PICO Summary
Population:
Adults aged ≥18 years with type 2 diabetes, receiving stable basal insulin therapy, with HbA1c levels between 7.0% and 10.0%.
Intervention:
Once-weekly subcutaneous semaglutide (0.5 mg or 1.0 mg).
Comparison:
Placebo (volume-matched, subcutaneous).
Outcome:
- Efficacy: Semaglutide 0.5 mg and 1.0 mg reduced HbA1c by 1.4% and 1.8%, respectively, vs. 0.1% in placebo (p < 0.0001). Weight loss was also significantly greater with semaglutide.
- Safety and Tolerability: Gastrointestinal side effects (nausea, vomiting) were more common with semaglutide, leading to higher discontinuation rates.
Clinical Summary
Main Finding:
Adding semaglutide to basal insulin significantly improves glycaemic control and body weight outcomes compared to placebo in type 2 diabetes.
Clinical Relevance:
This trial supports semaglutide as an effective add-on therapy to basal insulin in managing type 2 diabetes, though gastrointestinal tolerability is a consideration for patient adherence.
Study Overview:
- Type of Study: Randomised, double-blind, placebo-controlled, 30-week trial.
- Sample Size & Population: 397 patients with uncontrolled type 2 diabetes on basal insulin.
- Intervention Duration & Doses: 30 weeks of weekly semaglutide (0.5 mg or 1.0 mg).
- Comparison: Placebo.
Outcomes:
- Primary Measure (HbA1c): Greater reduction in HbA1c with semaglutide compared to placebo.
- Secondary Measure (Body Weight): Semaglutide showed a significant reduction in body weight versus placebo.
- Safety Profile: Higher incidence of gastrointestinal side effects with semaglutide; no unexpected safety issues.
Considerations:
The study’s duration limits long-term efficacy and safety conclusions. The higher gastrointestinal side effects may limit broader applicability, particularly for patients sensitive to such effects.
Reference:
Rodbard, H. W., Lingvay, I., Reed, J., de la Rosa, R., Rose, L., Sugimoto, D., et al. (2018). Journal of Clinical Endocrinology & Metabolism, 103(6), 2291–2301. doi:10.1210/jc.2018-00070.
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.
