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Study · Randomized controlled trial · 2021

4 results

Dasiglucagon, a next-generation ready-to-use glucagon analog, for treatment of severe hypoglycemia in children and adolescents with type 1 diabetes: Results of a phase 3, randomized controlled trial.

Battelino T, Tehranchi R, Bailey T, Dovc K, Melgaard A, Yager Stone J, Woerner S, von dem Berge T, DiMeglio L, Danne T

Pediatric diabetes9 Jun 2021Cited by 27 (Europe PMC)

PMID33934456 (opens in a new tab)PMCIDPMC8361970 (opens in a new tab)DOI10.1111/pedi.13220 (opens in a new tab)PepBankPUB-33934456
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In children and adolescents with type 1 diabetes, median recovery time was 10 min (95% CI 8-12) with dasiglucagon versus 30 min (20 to -) with placebo (P < .001).

    In plain wordsDasiglucagon restored glucose faster than placebo in children and adolescents with type 1 diabetes.

    Peptide
    Dasiglucagon
    Outcome
    DecreaseTime to glucose recovery
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.6 mg · subcutaneousAs given in this study (human).

    Measurements

    Median time to PG recovery
    10 min
    dasiglucagon 0.6 mg; 95% CI 8-12
    Median time to PG recovery
    30 min
    placebo; 95% CI 20 to -

    Source sentences

    Summary
    The median time (95% confidence interval) to PG recovery following SC injection was 10 min (8-12) for dasiglucagon vs. 30 min (20 to -) for placebo (P < .001); the median time for glucagon was 10 min (8-12), which did not include the time taken to reconstitute the lyophilized powder.
    2 context sentences
    Summary · context
    Participants were children and adolescents (6-17 years) with T1DM.
    Summary · context
    In this randomized double-blind trial, 42 participants were randomly allocated (2:1:1) to a single subcutaneous (SC) injection of dasiglucagon (0.6 mg), placebo, or reconstituted glucagon (GlucaGen; dosed per label) during insulin-induced hypoglycemia.
  2. 02HumanRandomized controlled trialEfficacy outcome

    All pediatric dasiglucagon recipients recovered within 20 min versus 2 of 11 placebo recipients (18%).

    In plain wordsAll children receiving dasiglucagon recovered within 20 minutes, compared with 18% receiving placebo.

    Peptide
    Dasiglucagon
    Outcome
    IncreaseRecovery within 20 minutes
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    0.6 mg · subcutaneousAs given in this study (human).

    Measurements

    Proportion with PG recovery within 20 min
    18%
    placebo (2 of 11)

    Source sentences

    Summary
    PG recovery was achieved in all participants in the dasiglucagon and glucagon groups within 20 min of dosing compared to 2 out of 11 patients (18%) with placebo.
    2 context sentences
    Summary · context
    Participants were children and adolescents (6-17 years) with T1DM.
    Summary · context
    In this randomized double-blind trial, 42 participants were randomly allocated (2:1:1) to a single subcutaneous (SC) injection of dasiglucagon (0.6 mg), placebo, or reconstituted glucagon (GlucaGen; dosed per label) during insulin-induced hypoglycemia.
  3. 03HumanRandomized controlled trialEfficacy outcome

    All pediatric glucagon recipients recovered within 20 min versus 2 of 11 placebo recipients (18%).

    In plain wordsAll children receiving glucagon recovered within 20 minutes, compared with 18% receiving placebo.

    Peptide
    Glucagon
    Outcome
    IncreaseRecovery within 20 minutes
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dosed per label · subcutaneousAs given in this study (human).

    Measurements

    Proportion with PG recovery within 20 min
    18%
    placebo (2 of 11)

    Source sentences

    Summary
    PG recovery was achieved in all participants in the dasiglucagon and glucagon groups within 20 min of dosing compared to 2 out of 11 patients (18%) with placebo.
    2 context sentences
    Summary · context
    Participants were children and adolescents (6-17 years) with T1DM.
    Summary · context
    In this randomized double-blind trial, 42 participants were randomly allocated (2:1:1) to a single subcutaneous (SC) injection of dasiglucagon (0.6 mg), placebo, or reconstituted glucagon (GlucaGen; dosed per label) during insulin-induced hypoglycemia.
  4. 04HumanNon-randomized trialEfficacy outcome

    In children and adolescents with type 1 diabetes, glucagon median recovery time was 10 min (95% CI 8-12), excluding reconstitution time.

    In plain wordsGlucagon restored glucose in a median 10 minutes, excluding preparation time.

    Peptide
    Glucagon
    Outcome
    Not applicableTime to glucose recovery
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    Dosed per label · subcutaneousAs given in this study (human).

    Measurements

    Median time to PG recovery
    10 min
    reconstituted glucagon (GlucaGen); 95% CI 8-12; excludes reconstitution time

    Source sentences

    Summary
    The median time (95% confidence interval) to PG recovery following SC injection was 10 min (8-12) for dasiglucagon vs. 30 min (20 to -) for placebo (P < .001); the median time for glucagon was 10 min (8-12), which did not include the time taken to reconstitute the lyophilized powder.
    2 context sentences
    Summary · context
    Participants were children and adolescents (6-17 years) with T1DM.
    Summary · context
    In this randomized double-blind trial, 42 participants were randomly allocated (2:1:1) to a single subcutaneous (SC) injection of dasiglucagon (0.6 mg), placebo, or reconstituted glucagon (GlucaGen; dosed per label) during insulin-induced hypoglycemia.

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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 3Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 2

    27 Oct 2026, 16:35 UTC

    Study data updated · source update from Europe PMC

  3. 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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