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Dasiglucagon Effectively Mitigates Postbariatric Postprandial Hypoglycemia: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial

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posted on 24.03.2022, 12:55 authored by Casper 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.

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