Obesity

Dasiglucagon Treatment for Postprandial Hypoglycemia After Gastric Bypass: A Randomized, Double-Blind, Placebo-Controlled Trial

Diabetes CarePublished Randomised controlled trial

Primary result · Time in level 1 hypoglycemia (<3.9 mmol/L)Result — go to the resultDifference −1.2 percentage points 95% CI −2.0 to −0.5

Authors' conclusion

Compared with placebo, 4 weeks of self-administered dasiglucagon effectively reduced clinically relevant hypoglycemia in individuals who had undergone Roux-en-Y gastric bypass surgery.

Study context

Population
Individuals after RYGB with CGM-verified postbariatric hypoglycemia (≥15 min at <3.9 mmol/L three or more times per week), Gentofte Hospital, Denmark; 23 womencrossover
Participants
24 individuals
Comparison
Self-administered SC dasiglucagon 120 μg vs placebo, 4-week treatment periods
Primary endpoint
CGM-captured percentage of time in level 1 hypoglycemia (<3.9 mmol/L)
Follow-up
4 weeks
Methodological detailsdouble-blind, placebo-controlled, crossover, proof-of-concept, single-centre
  • Double-blind
  • Placebo-controlled
  • Crossover
  • Proof-of-concept
  • Single-centre

Primary result

Time in level 1 hypoglycemia (<3.9 mmol/L)

Difference

−1.2 percentage points

95% CI −2.0 to −0.5

P = 0.002

Dasiglucagonvs Placebo
difference −1.2 percentage points (95% CI −2.0 to −0.5); P = 0.002

As reported in the abstract

Secondary outcomes

OutcomeDifference (percentage points) (95% CI)P value
Key secondary: time in level 2 hypoglycemia (<3.0 mmol/L) · 4 weeksReduced by 54%−0.4 (−0.6 to −0.2)P < 0.0001

Hypoglycemia corrected within 15 min per self-administration

P < 0.001

Safety

Adverse events

Dasiglucagon generally well tolerated, with mostly mild to moderate AEs of nausea

Original publication

Dasiglucagon Treatment for Postprandial Hypoglycemia After Gastric Bypass: A Randomized, Double-Blind, Placebo-Controlled Trial. Diabetes Care. Published 11 October 2023. doi:10.2337/dc23-1193

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