posted on 2022-03-24, 12:55authored byCasper K. Nielsen, Caroline C. Øhrstrøm, Urd L. Kielgast, Dorte L. Hansen, Bolette Hartmann, Jens J. Holst, Asger B. Lund, Tina Vilsbøll, Filip K. Knop
OBJECTIVE To
investigate the efficacy and safety of dasiglucagon, a novel stable glucagon analog
in a liquid formulation, in Roux-en-Y gastric bypass (RYGB)-operated individuals
suffering from post-bariatric hypoglycemia (PBH).
RESEARCH
DESIGN AND METHODS In a randomized, double-blind,
placebo-controlled crossover trial, 10 RYGB-operated participants with continuous
glucose monitoring (CGM)-verified PBH were randomized to three trial days, each
consisting of a 240-minute standardized liquid mixed meal test (MMT) with the subcutaneous
injection of either placebo, 80 µg, or 200 µg dasiglucagon.
RESULTS Compared
with placebo, treatment with both 80 and 200 µg dasiglucagon raised nadir plasma
glucose (PG) (placebo: 3.0 ± 0.2 mmol/L (mean ± standard error of the mean (SEM));
80 µg dasiglucagon: 3.9 ± 0.3 mmol/L, P = 0.002; 200 µg dasiglucagon:
4.5 ± 0.2 mmol/L, P = 0.0002) and reduced time in hypoglycemia (PG < 3.9 mmol/L) by 70.0 minutes (P = 0.030 and P = 0.008).
CONCLUSION Single-dose administration of dasiglucagon effectively
mitigated postprandial hypoglycemia.
Funding
This study was an independent investigator-initiated study. Zealand Pharma A/S funded the study and produced, packed, and delivered the trial drug. The funding and the trial drug were received as pure support without any kind of obligation to Zealand Pharma A/S. The investigators own all data.