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Study · Randomized controlled trial · n = 12 · 2025

2 results

Dasiglucagon in Children With Congenital Hyperinsulinism Up to 1 Year of Age: Results From a Randomized Clinical Trial.

De Leon DD, Banerjee I, Kummer S, Birch S, Bøge E, Ivkovic J, Kendall DM, Thornton PS

The Journal of clinical endocrinology and metabolism1 Jul 2025Cited by 2 (Europe PMC)

PMID39584500 (opens in a new tab)PMCIDPMC12261080 (opens in a new tab)DOI10.1210/clinem/dgae818 (opens in a new tab)PepBankPUB-39584500
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Summary

ContextCongenital hyperinsulinism (CHI) is a cause of persistent hypoglycemia in childhood with a considerable risk of lifelong neurological sequelae. Available pharmacological therapies are limited. Dasiglucagon is a glucagon analog for the treatment of hypoglycemia.ObjectiveTo assess the efficacy and safety of dasiglucagon in children with CHI up to 1 year of age.MethodsThis study included a randomized, crossover, double-blind, placebo-controlled part 1 and an open-label, single-arm part 2 at 4 centers in Germany, the United Kingdom, and the United States. Participants comprised children with CHI aged 7 days to 12 months who were dependent on IV glucose. In part 1, participants were randomized to dasiglucagon or placebo for 48 hours, then crossed over to the other treatment for 48 hours. In part 2, all participants received dasiglucagon for 21 days. The primary outcome was mean IV glucose infusion rate (GIR) in the last 12 hours of part 1.ResultsBetween June 19, 2020, and February 9, 2022, 12 eligible participants were randomized to dasiglucagon-placebo (n = 7) or placebo-dasiglucagon (n = 5). The IV GIR was significantly reduced with dasiglucagon compared with placebo (least-squares mean 4.3 mg/kg/min [95% confidence interval [CI], 1.04 to 7.60 mg/kg/min] and 9.5 mg/kg/min [95% CI, 6.24 to 12.81 mg/kg/min], respectively; P = .004). The most frequent adverse events in both treatment groups were gastrointestinal, dermatological, and metabolism and nutritional disorders.ConclusionIn infants with CHI, dasiglucagon significantly reduced the amount of IV glucose needed to maintain euglycemia compared with placebo. Dasiglucagon represents a promising treatment for the management of CHI.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In infants with congenital hyperinsulinism, dasiglucagon reduced IV glucose infusion rate versus placebo: 4.3 versus 9.5 mg/kg/min, P = .004.

    In plain wordsIn infants with congenital hyperinsulinism, dasiglucagon reduced the glucose infusion rate compared with placebo.

    Peptide
    Dasiglucagon
    Outcome
    DecreaseIV glucose infusion rate
    Study

    n = 12

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dose not stated · 48 hoursAs given in this study (human).

    Measurements

    Glucose infusion rate, least-squares mean
    4.3 mg/kg/min
    dasiglucagon
    95% CI, glucose infusion rate
    1.04 to 7.6 mg/kg/min
    dasiglucagon
    Glucose infusion rate, least-squares mean
    9.5 mg/kg/min
    placebo
    95% CI, glucose infusion rate
    6.24 to 12.81 mg/kg/min
    placebo
    P
    0.004
    dasiglucagon versus placebo

    Source sentences

    Summary
    The IV GIR was significantly reduced with dasiglucagon compared with placebo (least-squares mean 4.3 mg/kg/min [95% confidence interval [CI], 1.04 to 7.60 mg/kg/min] and 9.5 mg/kg/min [95% CI, 6.24 to 12.81 mg/kg/min], respectively; P = .004).
    4 context sentences
    Summary · context
    In part 1, participants were randomized to dasiglucagon or placebo for 48 hours, then crossed over to the other treatment for 48 hours.
    Summary · context
    The primary outcome was mean IV glucose infusion rate (GIR) in the last 12 hours of part 1.
    Summary · context
    This study included a randomized, crossover, double-blind, placebo-controlled part 1 and an open-label, single-arm part 2 at 4 centers in Germany, the United Kingdom, and the United States.
    Summary · context
    Participants comprised children with CHI aged 7 days to 12 months who were dependent on IV glucose.
  2. 02HumanNon-randomized trialSafety outcome

    In infants with congenital hyperinsulinism, frequent adverse events in both groups included gastrointestinal, dermatological, and metabolism and nutritional disorders.

    In plain wordsIn infants, frequent adverse events in both groups included gastrointestinal, skin, and metabolism and nutritional disorders.

    Peptide
    Dasiglucagon
    Outcome
    Direction not reportedFrequent adverse event categories
    Study

    n = 12

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    The most frequent adverse events in both treatment groups were gastrointestinal, dermatological, and metabolism and nutritional disorders.
    2 context sentences
    Summary · context
    This study included a randomized, crossover, double-blind, placebo-controlled part 1 and an open-label, single-arm part 2 at 4 centers in Germany, the United Kingdom, and the United States.
    Summary · context
    Participants comprised children with CHI aged 7 days to 12 months who were dependent on IV glucose.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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