Dasiglucagon Treatment for Postprandial Hypoglycemia After Gastric Bypass: A Randomized, Double-Blind, Placebo-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 −0.5Authors' 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
| Outcome | Difference (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 | |
| −1−0.500.5Difference, percentage points (linear scale) |
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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