Title: Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial

Kapitza, C et al.


What You Need to Know:

In patients with type 2 diabetes, 12-week treatment with semaglutide, a glucagon-like peptide-1 analog, improved both beta cell function as well as glycemic control.

Trial Design:

  • Double-blind, placebo-controlled, parallel-group study evaluated the effect of semaglutide on beta cell function and glycemic control in patients with type 2 diabetes
  • Included 18-64 year old type 2 diabetic patients with an HbA1c of 6.5-9.0% and a body mass index of 20.0-35.0 kg/m2, who were being treated with diet and exercise and/or metformin with no dose change 30 days before screening
  • Patients were randomized to receive semaglutide 1mg (0.25, 0.5, 1mg escalated) administered subcutaneously once weekly or placebo over 12 weeks
  • Coprimary endpoints: “changes from baseline to end of treatment in the first (AUC0-10min) and second (AUC10-120min) insulin secretion phases, as measured by the IVGTT”
  • Additional assessments: arginine stimulation test (AST), 24-hour meal stimulation test, insulin secretion rate (ISR) via a graded glucose infusion test (GGIT) conducted in both treated participants and untreated healthy participants, safety endpoints

Key Outcomes:

  • 37 patients received semaglutide, 38 patients received placebo
  • “Following IVGTT, for insulin, both AUC0-10min and AUC10-120min were significantly increased with semaglutide (estimated treatment ration [95% CI] 3.02 [2.53, 3.60] and 2.10 [1.86, 2.37], respectively; P<0.0001)”
  • 24-hour meal test: semaglutide patients had decreased fasting, postprandial, and overall (AUC0-24h) glucose and glucagon responses compared to placebo (P<0.0001)
  • AST: increased maximal insulin capacity after treatment with semaglutide
  • “During GGIT, semaglutide significantly increased ISR to levels similar to those in healthy participants”
  • Safety: semaglutide was well tolerated among patients