Dasiglucagon Treatment for Postprandial Hypoglycemia After Gastric Bypass: A Randomized, Double-Blind, Placebo-Controlled Trial
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Dasiglucagon Treatment for Postprandial Hypoglycemia After Gastric Bypass : A Randomized, Double-Blind, Placebo-Controlled Trial. / Nielsen, Casper K.; Øhrstrøm, Caroline C.; Houji, Inas J.K.; Helsted, Mads M.; Krogh, Liva S.L.; Johansen, Nicklas J.; Hartmann, Bolette; Holst, Jens J.; Vilsbøll, Tina; Knop, Filip K.
In: Diabetes Care, Vol. 46, No. 12, 2023, p. 2208-2217.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Dasiglucagon Treatment for Postprandial Hypoglycemia After Gastric Bypass
T2 - A Randomized, Double-Blind, Placebo-Controlled Trial
AU - Nielsen, Casper K.
AU - Øhrstrøm, Caroline C.
AU - Houji, Inas J.K.
AU - Helsted, Mads M.
AU - Krogh, Liva S.L.
AU - Johansen, Nicklas J.
AU - Hartmann, Bolette
AU - Holst, Jens J.
AU - Vilsbøll, Tina
AU - Knop, Filip K.
N1 - Publisher Copyright: © 2023 by the American Diabetes Association.
PY - 2023
Y1 - 2023
N2 - OBJECTIVE Postbariatric hypoglycemia affects >50% of individuals who have undergone Roux-en-Y gastric bypass surgery. Despite the often debilitating nature of this complication, existing treatment options are limited and often inefficient. Dasiglucagon is a stable gluca-gon analog available in a ready-to-use formulation and was recently shown to mitigate postbariatric hypoglycemia in experimental settings. Here, we aimed to evaluate the hypoglycemic hindering potential of dasiglucagon in an outpatient trial. RESEARCH DESIGN AND METHODS We conducted a randomized, double-blind, placebo-controlled, crossover, proof-of-concept study at the Center for Clinical Metabolic Research at Gentofte Hospital in Denmark. The study included 24 individuals who had undergone Roux-en-Y gastric bypass surgery (n = 23 women) with continuous glucose monitor–verified postbariatric hypoglycemia ($15 min at <3.9 mmol/L three or more times per week) randomly assigned to two treatment periods of 4 weeks of self-administered subcutaneous dasi-glucagon at 120 lg or placebo. The primary and key secondary outcomes were continuous glucose monitor–captured percentage of time in level 1 and 2 hypoglycemia (<3.9 and <3.0 mmol/L), respectively. RESULTS Compared with placebo, treatment with dasiglucagon significantly reduced time in level 1 hypoglycemia by 33% (21.2 percentage points; 95% CI 22.0 to 20.5; P = 0.002) and time in level 2 hypoglycemia by 54% (20.4 percentage points; 95% CI 20.6 to 20.2; P < 0.0001). Furthermore, dasiglucagon corrected hypoglycemia within 15 min in 401 of 412 self-administrations, compared with 104 of 357 placebo self-administrations (97.3% vs. 29.1% correction of hypoglycemia rate; P < 0.001). Dasiglucagon was gener-ally well tolerated, with mostly mild to moderate adverse events of nausea. CONCLUSIONS 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.
AB - OBJECTIVE Postbariatric hypoglycemia affects >50% of individuals who have undergone Roux-en-Y gastric bypass surgery. Despite the often debilitating nature of this complication, existing treatment options are limited and often inefficient. Dasiglucagon is a stable gluca-gon analog available in a ready-to-use formulation and was recently shown to mitigate postbariatric hypoglycemia in experimental settings. Here, we aimed to evaluate the hypoglycemic hindering potential of dasiglucagon in an outpatient trial. RESEARCH DESIGN AND METHODS We conducted a randomized, double-blind, placebo-controlled, crossover, proof-of-concept study at the Center for Clinical Metabolic Research at Gentofte Hospital in Denmark. The study included 24 individuals who had undergone Roux-en-Y gastric bypass surgery (n = 23 women) with continuous glucose monitor–verified postbariatric hypoglycemia ($15 min at <3.9 mmol/L three or more times per week) randomly assigned to two treatment periods of 4 weeks of self-administered subcutaneous dasi-glucagon at 120 lg or placebo. The primary and key secondary outcomes were continuous glucose monitor–captured percentage of time in level 1 and 2 hypoglycemia (<3.9 and <3.0 mmol/L), respectively. RESULTS Compared with placebo, treatment with dasiglucagon significantly reduced time in level 1 hypoglycemia by 33% (21.2 percentage points; 95% CI 22.0 to 20.5; P = 0.002) and time in level 2 hypoglycemia by 54% (20.4 percentage points; 95% CI 20.6 to 20.2; P < 0.0001). Furthermore, dasiglucagon corrected hypoglycemia within 15 min in 401 of 412 self-administrations, compared with 104 of 357 placebo self-administrations (97.3% vs. 29.1% correction of hypoglycemia rate; P < 0.001). Dasiglucagon was gener-ally well tolerated, with mostly mild to moderate adverse events of nausea. CONCLUSIONS 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.
U2 - 10.2337/dc23-1193
DO - 10.2337/dc23-1193
M3 - Journal article
C2 - 37819999
AN - SCOPUS:85178346498
VL - 46
SP - 2208
EP - 2217
JO - Diabetes Care
JF - Diabetes Care
SN - 1935-5548
IS - 12
ER -
ID: 375796262