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

Casper K Nielsen; Caroline C Øhrstrøm; Urd L. Kielgast; Dorte L. Hansen; Bolette Hartmann; Jens J Holst; Asger Lund; Tina Vilsbøll; Filip K Knop

doi:10.2337/dc21-2252

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

Casper K Nielsen, Caroline C Øhrstrøm, Urd L. Kielgast, Dorte L. Hansen, Bolette Hartmann, Jens J Holst, Asger Lund, Tina Vilsbøll, Filip K Knop

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Abstract

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 postbariatric hypoglycemia (PBH).

RESEARCH DESIGN AND METHODS: 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.

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 ± 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).

CONCLUSIONS: Single-dose administration of dasiglucagon effectively mitigated postprandial hypoglycemia.

Originalsprog	Engelsk
Tidsskrift	Diabetes Care
Vol/bind	45
Udgave nummer	6
Sider (fra-til)	1476–1481
ISSN	1935-5548
DOI	https://doi.org/10.2337/dc21-2252
Status	Udgivet - 2022

Bibliografisk note

Adgang til dokumentet

10.2337/dc21-2252

Citationsformater

Dasiglucagon Effectively Mitigates Postbariatric Postprandial Hypoglycemia : A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. / Nielsen, Casper K; Øhrstrøm, Caroline C; Kielgast, Urd L.; Hansen, Dorte L.; Hartmann, Bolette ; Holst, Jens J ; Lund, Asger ; Vilsbøll, Tina ; Knop, Filip K.

I: Diabetes Care, Bind 45, Nr. 6, 2022, s. 1476–1481.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Nielsen, Casper K ; Øhrstrøm, Caroline C ; Kielgast, Urd L. ; Hansen, Dorte L. ; Hartmann, Bolette ; Holst, Jens J ; Lund, Asger ; Vilsbøll, Tina ; Knop, Filip K. / Dasiglucagon Effectively Mitigates Postbariatric Postprandial Hypoglycemia : A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. I: Diabetes Care. 2022 ; Bind 45, Nr. 6. s. 1476–1481.

@article{8104d825b1324b03a20099823cc26605,

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

abstract = "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 postbariatric hypoglycemia (PBH).RESEARCH DESIGN AND METHODS: 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.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 ± 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).CONCLUSIONS: Single-dose administration of dasiglucagon effectively mitigated postprandial hypoglycemia.",

author = "Nielsen, {Casper K} and {\O}hrstr{\o}m, {Caroline C} and Kielgast, {Urd L.} and Hansen, {Dorte L.} and Bolette Hartmann and Holst, {Jens J} and Asger Lund and Tina Vilsb{\o}ll and Knop, {Filip K}",

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year = "2022",

doi = "10.2337/dc21-2252",

language = "English",

volume = "45",

pages = "1476–1481",

journal = "Diabetes Care",

issn = "1935-5548",

publisher = "American Diabetes Association",

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TY - JOUR

T1 - Dasiglucagon Effectively Mitigates Postbariatric Postprandial Hypoglycemia

T2 - A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial

AU - Nielsen, Casper K

AU - Øhrstrøm, Caroline C

AU - Kielgast, Urd L.

AU - Hansen, Dorte L.

AU - Hartmann, Bolette

AU - Holst, Jens J

AU - Lund, Asger

AU - Vilsbøll, Tina

AU - Knop, Filip K

PY - 2022

Y1 - 2022

N2 - 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 postbariatric hypoglycemia (PBH).RESEARCH DESIGN AND METHODS: 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.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 ± 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).CONCLUSIONS: Single-dose administration of dasiglucagon effectively mitigated postprandial hypoglycemia.

AB - 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 postbariatric hypoglycemia (PBH).RESEARCH DESIGN AND METHODS: 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.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 ± 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).CONCLUSIONS: Single-dose administration of dasiglucagon effectively mitigated postprandial hypoglycemia.

U2 - 10.2337/dc21-2252

DO - 10.2337/dc21-2252

M3 - Journal article

C2 - 35320361

VL - 45

SP - 1476

EP - 1481

JO - Diabetes Care

JF - Diabetes Care

SN - 1935-5548

IS - 6

ER -