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

• Published in: Diabetes care Vol. 45; no. 6; pp. 1476 - 1481
• Main Authors: Nielsen, Casper K, Øhrstrøm, Caroline C, Kielgast, Urd L, Hansen, Dorte L, Hartmann, Bolette, Holst, Jens J, Lund, Asger, Vilsbøll, Tina, Knop, Filip K
• Format: Journal Article
• Language: English
• Published: United States American Diabetes Association 02-06-2022
• Subjects: Blood Glucose; Blood Glucose Self-Monitoring; Clinical outcomes; Cross-Over Studies; Diabetes; Double-Blind Method; Double-blind studies; Gastric bypass; Gastric Bypass - adverse effects; Gastrointestinal surgery; Glucagon; Glucagon - analogs & derivatives; Glucose; Glucose monitoring; Humans; Hypoglycemia; Hypoglycemia - drug therapy; Hypoglycemia - etiology; Hypoglycemia - prevention & control; Insulin - therapeutic use; Meals; Obesity; Patient safety; Placebos; Postoperative period; Research design
• ISSN: 0149-5992; 1935-5548
• DOI: 10.2337/dc21-2252

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 postbariatric hypoglycemia (PBH).
In a randomized, double-blind, placebo-controlled, crossover trial, 10 RYGB-operated participants with continuous glucose monitoring-verified PBH were randomly assigned to 3 trial days, each consisting of a 240-min standardized liquid mixed-meal test with the subcutaneous injection of placebo or 80 μg or 200 μg dasiglucagon.
Compared with placebo, treatment with both 80 and 200 μg dasiglucagon raised nadir plasma glucose (PG) (placebo: 3.0 ± 0.2 mmol/L [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 min (P = 0.030 and P = 0.008).
Single-dose administration of dasiglucagon effectively mitigated postprandial hypoglycemia.