Skip to content

Study · Randomized controlled trial · n = 32 · 2024

7 results

Dasiglucagon for the Treatment of Congenital Hyperinsulinism: A Randomized Phase 3 Trial in Infants and Children.

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

The Journal of clinical endocrinology and metabolism1 Mar 2024Cited by 9 (Europe PMC)

PMID37930757 (opens in a new tab)PMCIDPMC10940263 (opens in a new tab)DOI10.1210/clinem/dgad648 (opens in a new tab)PepBankPUB-37930757
Download PDFPubMedAsk about this study
Jump to 7 results

Summary

ContextCongenital hyperinsulinism (CHI) is characterized by dysregulated insulin secretion causing hypoglycemia and consequent brain damage. Dasiglucagon is a glucagon analogue under investigation to treat CHI.ObjectiveTo evaluate the efficacy and safety of dasiglucagon delivered via continuous subcutaneous infusion to children with CHI and persistent hypoglycemia as add-on to standard of care (SoC).MethodsIn this open-label trial, patients were randomized 1:1 to SoC or SoC + dasiglucagon (10-70 µg/h) for 4 weeks. In the following 4 weeks, all patients received dasiglucagon + SoC. Hypoglycemia was assessed by self-monitored plasma glucose (SMPG) and blinded continuous glucose monitoring (CGM). Primary endpoint was average number of SMPG-detected hypoglycemia episodes/week (SMPG <3.9 mmol/L) during Weeks 2 to 4.ResultsThirty-two patients (0.6-10.9 years) were randomly assigned to dasiglucagon + SoC (n = 16) or SoC (n = 16). The rate of SMPG-detected hypoglycemia decreased from baseline in both groups, but with no statistically significant difference during Weeks 2 to 4 (event rate ratio: 0.85 [0.54; 1.36], P = .5028). However, dasiglucagon administration resulted in a 43% reduction in CGM-detected hypoglycemia (<3.9 mmol/L) vs SoC alone during Weeks 2 to 4 (post hoc analysis; event rate ratio: 0.57 [0.39; 0.83], P = .0029). Dasiglucagon enabled reductions (of 37% to 61%) in all other measures of hypoglycemia assessed by CGM vs SoC alone including extent and percent time in hypoglycemia (post hoc analyses). Dasiglucagon appeared safe and well tolerated. Skin and gastrointestinal events were more frequent with dasiglucagon + SoC than SoC only.ConclusionClinically meaningful reductions in all CGM-recorded measures of hypoglycemia support using dasiglucagon as a potential treatment for CHI.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In children with CHI, SMPG-detected hypoglycemia decreased from baseline in both groups, with no statistically significant difference between dasiglucagon plus standard care and standard care alone during Weeks 2 to 4.

    In plain wordsIn children with CHI, self-monitored hypoglycemia fell in both groups, with no statistically significant difference between dasiglucagon plus standard care and standard care alone.

    Peptide
    Dasiglucagon
    Outcome
    No significant changeSMPG-detected hypoglycemia episodes
    Study

    n = 32

    Comparator
    Standard of care alone
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    10-70 µg/h · continuous subcutaneous infusion · 4 weeksAs given in this study (human).

    Measurements

    Event rate ratio
    0.85 ratio
    dasiglucagon plus standard care versus standard care
    95% CI, event rate ratio
    0.54 to 1.36 ratio
    dasiglucagon plus standard care versus standard care
    P
    0.5028
    between groups

    Source sentences

    Summary
    The rate of SMPG-detected hypoglycemia decreased from baseline in both groups, but with no statistically significant difference during Weeks 2 to 4 (event rate ratio: 0.85 [0.54; 1.36], P = .5028).
    3 context sentences
    Summary · context
    Primary endpoint was average number of SMPG-detected hypoglycemia episodes/week (SMPG <3.9 mmol/L) during Weeks 2 to 4.
    Summary · context
    To evaluate the efficacy and safety of dasiglucagon delivered via continuous subcutaneous infusion to children with CHI and persistent hypoglycemia as add-on to standard of care (SoC).
    Summary · context
    In this open-label trial, patients were randomized 1:1 to SoC or SoC + dasiglucagon (10-70 µg/h) for 4 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In children with CHI, dasiglucagon reduced CGM-detected hypoglycemia by 43% versus standard care alone during Weeks 2 to 4 in a post hoc analysis.

    In plain wordsIn children with CHI, dasiglucagon reduced monitor-detected hypoglycemia compared with standard care alone in a post hoc analysis.

    Peptide
    Dasiglucagon
    Outcome
    DecreaseCGM-detected hypoglycemia
    Study

    n = 32

    Comparator
    Standard of care alone
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    10-70 µg/h · continuous subcutaneous infusion · 4 weeksAs given in this study (human).

    Measurements

    Reduction
    43%
    CGM-detected hypoglycemia
    Event rate ratio
    0.57 ratio
    versus standard care alone
    95% CI, event rate ratio
    0.39 to 0.83 ratio
    versus standard care alone
    P
    0.0029
    versus standard care alone

    Source sentences

    Summary
    However, dasiglucagon administration resulted in a 43% reduction in CGM-detected hypoglycemia (<3.9 mmol/L) vs SoC alone during Weeks 2 to 4 (post hoc analysis; event rate ratio: 0.57 [0.39; 0.83], P = .0029).
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dasiglucagon delivered via continuous subcutaneous infusion to children with CHI and persistent hypoglycemia as add-on to standard of care (SoC).
    Summary · context
    In this open-label trial, patients were randomized 1:1 to SoC or SoC + dasiglucagon (10-70 µg/h) for 4 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In children with CHI, dasiglucagon reduced CGM-assessed extent of hypoglycemia versus standard care alone in post hoc analyses reporting reductions of 37% to 61% across measures.

    In plain wordsIn children with CHI, dasiglucagon reduced the extent of hypoglycemia compared with standard care alone in post hoc analyses.

    Peptide
    Dasiglucagon
    Outcome
    DecreaseExtent of hypoglycemia
    Study

    n = 32

    Comparator
    Standard of care alone
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    10-70 µg/h · continuous subcutaneous infusion · 4 weeksAs given in this study (human).

    Measurements

    Reduction across CGM measures
    37 to 61%
    range across measures, not an outcome-specific estimate

    Source sentences

    Summary
    Dasiglucagon enabled reductions (of 37% to 61%) in all other measures of hypoglycemia assessed by CGM vs SoC alone including extent and percent time in hypoglycemia (post hoc analyses).
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dasiglucagon delivered via continuous subcutaneous infusion to children with CHI and persistent hypoglycemia as add-on to standard of care (SoC).
    Summary · context
    In this open-label trial, patients were randomized 1:1 to SoC or SoC + dasiglucagon (10-70 µg/h) for 4 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In children with CHI, dasiglucagon reduced CGM-assessed percent time in hypoglycemia versus standard care alone in post hoc analyses reporting reductions of 37% to 61% across measures.

    In plain wordsIn children with CHI, dasiglucagon reduced time in hypoglycemia compared with standard care alone in post hoc analyses.

    Peptide
    Dasiglucagon
    Outcome
    DecreasePercent time in hypoglycemia
    Study

    n = 32

    Comparator
    Standard of care alone
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    10-70 µg/h · continuous subcutaneous infusion · 4 weeksAs given in this study (human).

    Measurements

    Reduction across CGM measures
    37 to 61%
    range across measures, not an outcome-specific estimate

    Source sentences

    Summary
    Dasiglucagon enabled reductions (of 37% to 61%) in all other measures of hypoglycemia assessed by CGM vs SoC alone including extent and percent time in hypoglycemia (post hoc analyses).
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dasiglucagon delivered via continuous subcutaneous infusion to children with CHI and persistent hypoglycemia as add-on to standard of care (SoC).
    Summary · context
    In this open-label trial, patients were randomized 1:1 to SoC or SoC + dasiglucagon (10-70 µg/h) for 4 weeks.
  5. 05HumanRandomized controlled trialSafety outcome

    In children with CHI, skin events were more frequent with dasiglucagon plus standard care than standard care alone.

    In plain wordsIn children with CHI, skin events were more frequent with dasiglucagon plus standard care than standard care alone.

    Peptide
    Dasiglucagon
    Outcome
    IncreaseSkin events
    Study

    n = 32

    Comparator
    Standard of care alone
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    10-70 µg/h · continuous subcutaneous infusion · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Skin and gastrointestinal events were more frequent with dasiglucagon + SoC than SoC only.
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dasiglucagon delivered via continuous subcutaneous infusion to children with CHI and persistent hypoglycemia as add-on to standard of care (SoC).
    Summary · context
    In this open-label trial, patients were randomized 1:1 to SoC or SoC + dasiglucagon (10-70 µg/h) for 4 weeks.
  6. 06HumanRandomized controlled trialSafety outcome

    In children with CHI, gastrointestinal events were more frequent with dasiglucagon plus standard care than standard care alone.

    In plain wordsIn children with CHI, gastrointestinal events were more frequent with dasiglucagon plus standard care than standard care alone.

    Peptide
    Dasiglucagon
    Outcome
    IncreaseGastrointestinal events
    Study

    n = 32

    Comparator
    Standard of care alone
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    10-70 µg/h · continuous subcutaneous infusion · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Skin and gastrointestinal events were more frequent with dasiglucagon + SoC than SoC only.
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dasiglucagon delivered via continuous subcutaneous infusion to children with CHI and persistent hypoglycemia as add-on to standard of care (SoC).
    Summary · context
    In this open-label trial, patients were randomized 1:1 to SoC or SoC + dasiglucagon (10-70 µg/h) for 4 weeks.
  7. 07HumanNon-randomized trialSafety outcome

    In children with CHI, dasiglucagon appeared safe and well tolerated.

    In plain wordsIn children with CHI, dasiglucagon appeared safe and well tolerated.

    Peptide
    Dasiglucagon
    Outcome
    Not applicableOverall safety and tolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    10-70 µg/h · continuous subcutaneous infusionAs given in this study (human).

    Source sentences

    Summary
    Dasiglucagon appeared safe and well tolerated.
    2 context sentences
    Summary · context
    To evaluate the efficacy and safety of dasiglucagon delivered via continuous subcutaneous infusion to children with CHI and persistent hypoglycemia as add-on to standard of care (SoC).
    Summary · context
    In this open-label trial, patients were randomized 1:1 to SoC or SoC + dasiglucagon (10-70 µg/h) for 4 weeks.

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.