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Study · Randomized controlled trial · 2022

8 results

Dasiglucagon Effects on QTc in Healthy Volunteers: A Randomized, Placebo-Controlled, Dose-Escalation, Double-Blind Study.

Tehranchi R, Pettersson J, Melgaard AE, Seitz F, Valeur A, Maarbjerg SJ

Current therapeutic research, clinical and experimental29 Mar 2022Cited by 2 (Europe PMC)

PMID35464292 (opens in a new tab)PMCIDPMC9026613 (opens in a new tab)DOI10.1016/j.curtheres.2022.100668 (opens in a new tab)PepBankPUB-35464292
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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-ND. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In healthy volunteers, dasiglucagon had no clinically relevant effect on heart rate at the doses studied.

    In plain wordsIn healthy volunteers, dasiglucagon had no clinically relevant effect on heart rate compared with placebo.

    Peptide
    Dasiglucagon
    Outcome
    Direction not reportedHeart rate
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    0.03-1.5 mg · intravenousAs given in this study (human).

    Source sentences

    Summary
    At the doses studied, dasiglucagon did not have any clinically relevant effect on heart rate, PR interval, or QRS duration.
    4 context sentences
    Summary · context
    This double-blind, placebo-controlled, dose-escalation Phase I trial was conducted at a single center in Germany between November 2018 and June 2019.
    Summary · context
    Sixty healthy volunteers aged 18 to 45 years were randomized within dose cohorts to receive intravenous dasiglucagon, intravenous placebo, or subcutaneous dasiglucagon.
    Summary · context
    In the intravenous administration cohorts, doses ranged from 0.03 mg to 1.5 mg.
    Summary · context
    The subcutaneous administration cohort received the approved 0.6 mg dose.
  2. 02HumanRandomized controlled trialSafety outcome

    In healthy volunteers, dasiglucagon had no clinically relevant effect on PR interval at the doses studied.

    In plain wordsIn healthy volunteers, dasiglucagon had no clinically relevant effect on the heart's PR interval compared with placebo.

    Peptide
    Dasiglucagon
    Outcome
    Direction not reportedPR interval
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    0.03-1.5 mg · intravenousAs given in this study (human).

    Source sentences

    Summary
    At the doses studied, dasiglucagon did not have any clinically relevant effect on heart rate, PR interval, or QRS duration.
    4 context sentences
    Summary · context
    This double-blind, placebo-controlled, dose-escalation Phase I trial was conducted at a single center in Germany between November 2018 and June 2019.
    Summary · context
    Sixty healthy volunteers aged 18 to 45 years were randomized within dose cohorts to receive intravenous dasiglucagon, intravenous placebo, or subcutaneous dasiglucagon.
    Summary · context
    In the intravenous administration cohorts, doses ranged from 0.03 mg to 1.5 mg.
    Summary · context
    The subcutaneous administration cohort received the approved 0.6 mg dose.
  3. 03HumanRandomized controlled trialSafety outcome

    In healthy volunteers, dasiglucagon had no clinically relevant effect on QRS duration at the doses studied.

    In plain wordsIn healthy volunteers, dasiglucagon had no clinically relevant effect on the heart's QRS duration compared with placebo.

    Peptide
    Dasiglucagon
    Outcome
    Direction not reportedQRS duration
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    0.03-1.5 mg · intravenousAs given in this study (human).

    Source sentences

    Summary
    At the doses studied, dasiglucagon did not have any clinically relevant effect on heart rate, PR interval, or QRS duration.
    4 context sentences
    Summary · context
    This double-blind, placebo-controlled, dose-escalation Phase I trial was conducted at a single center in Germany between November 2018 and June 2019.
    Summary · context
    Sixty healthy volunteers aged 18 to 45 years were randomized within dose cohorts to receive intravenous dasiglucagon, intravenous placebo, or subcutaneous dasiglucagon.
    Summary · context
    In the intravenous administration cohorts, doses ranged from 0.03 mg to 1.5 mg.
    Summary · context
    The subcutaneous administration cohort received the approved 0.6 mg dose.
  4. 04HumanRandomized controlled trialSafety outcome

    In healthy volunteers, dasiglucagon produced minor QTcF prolongation without clear dose or concentration dependency.

    In plain wordsIn healthy volunteers, dasiglucagon produced minor QTcF prolongation without clear dose or concentration dependency.

    Peptide
    Dasiglucagon
    Outcome
    IncreaseQTcF prolongation
    Study

    n: not reported in source

    Outcome group
    Heart function · Cardiovascular
    Studied dose
    0.03-1.5 mg · intravenousAs given in this study (human).

    Source sentences

    Summary
    A minor prolongation of the QTcF interval was observed without any clear dose or concentration dependency.
    4 context sentences
    Summary · context
    This double-blind, placebo-controlled, dose-escalation Phase I trial was conducted at a single center in Germany between November 2018 and June 2019.
    Summary · context
    Sixty healthy volunteers aged 18 to 45 years were randomized within dose cohorts to receive intravenous dasiglucagon, intravenous placebo, or subcutaneous dasiglucagon.
    Summary · context
    In the intravenous administration cohorts, doses ranged from 0.03 mg to 1.5 mg.
    Summary · context
    The subcutaneous administration cohort received the approved 0.6 mg dose.
  5. 05HumanRandomized controlled trialSafety outcome

    In healthy volunteers, both models placed mean placebo-corrected QTcF changes and 90% CIs below 10 ms; the linear model fit poorly at low concentrations.

    In plain wordsIn healthy volunteers, both models placed placebo-corrected QTcF changes below the regulatory threshold, although the linear model fit poorly at low concentrations.

    Peptide
    Dasiglucagon
    Outcome
    Not applicableModeled placebo-corrected QTcF change
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    0.03-1.5 mg · intravenousAs given in this study (human).

    Measurements

    Mean and 90% CI QTcF change
    < 10 ms
    both models, placebo-corrected

    Source sentences

    Summary
    Both the linear and Emax models predicted mean and 90% CIs of placebo-corrected change in QTcF remained below 10 ms (the threshold of regulatory concern), although the linear model did not fit the data well at low dasiglucagon plasma concentrations.
    4 context sentences
    Summary · context
    This double-blind, placebo-controlled, dose-escalation Phase I trial was conducted at a single center in Germany between November 2018 and June 2019.
    Summary · context
    Sixty healthy volunteers aged 18 to 45 years were randomized within dose cohorts to receive intravenous dasiglucagon, intravenous placebo, or subcutaneous dasiglucagon.
    Summary · context
    In the intravenous administration cohorts, doses ranged from 0.03 mg to 1.5 mg.
    Summary · context
    The subcutaneous administration cohort received the approved 0.6 mg dose.
  6. 06HumanRandomized controlled trialSafety outcome

    In healthy volunteers, the modeled maximum dasiglucagon QTcF effect was 3.6 ms, with a 90% CI of 1.23-5.95 ms.

    In plain wordsIn healthy volunteers, the modeled maximum dasiglucagon QTcF effect was 3.6 ms compared with placebo.

    Peptide
    Dasiglucagon
    Outcome
    Not applicableMaximum QTcF effect
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    0.03-1.5 mg · intravenousAs given in this study (human).

    Measurements

    Maximum QTcF effect
    3.6 ms
    Emax model
    90% CI
    1.23 to 5.95 ms
    Emax

    Source sentences

    Summary
    In the Emax model, the Emax of dasiglucagon was 3.6 ms (90% CI, 1.23-5.95 ms), and the amount to produce half the effect of Emax) was 426.0 pmol/L (90% CI, -48.8 to 900.71 pmol/L).
    4 context sentences
    Summary · context
    This double-blind, placebo-controlled, dose-escalation Phase I trial was conducted at a single center in Germany between November 2018 and June 2019.
    Summary · context
    Sixty healthy volunteers aged 18 to 45 years were randomized within dose cohorts to receive intravenous dasiglucagon, intravenous placebo, or subcutaneous dasiglucagon.
    Summary · context
    In the intravenous administration cohorts, doses ranged from 0.03 mg to 1.5 mg.
    Summary · context
    The subcutaneous administration cohort received the approved 0.6 mg dose.
  7. 07HumanRandomized controlled trialActivity measurement

    In healthy volunteers, the modeled concentration for half-maximal QTcF effect was 426.0 pmol/L, with a 90% CI of -48.8 to 900.71 pmol/L.

    In plain wordsIn healthy volunteers, the modeled dasiglucagon concentration for half-maximal QTcF effect was 426.0 pmol/L.

    Peptide
    Dasiglucagon
    Outcome
    Not applicableConcentration for half-maximal QTcF effect
    Study

    n: not reported in source

    Outcome group
    Heart function · Cardiovascular
    Studied dose
    0.03-1.5 mg · intravenousAs given in this study (human).

    Measurements

    Half-maximal effect concentration
    426 pmol/L
    Emax model
    90% CI
    −48.8 to 900.71 pmol/L
    half-maximal effect concentration

    Source sentences

    Summary
    In the Emax model, the Emax of dasiglucagon was 3.6 ms (90% CI, 1.23-5.95 ms), and the amount to produce half the effect of Emax) was 426.0 pmol/L (90% CI, -48.8 to 900.71 pmol/L).
    4 context sentences
    Summary · context
    This double-blind, placebo-controlled, dose-escalation Phase I trial was conducted at a single center in Germany between November 2018 and June 2019.
    Summary · context
    Sixty healthy volunteers aged 18 to 45 years were randomized within dose cohorts to receive intravenous dasiglucagon, intravenous placebo, or subcutaneous dasiglucagon.
    Summary · context
    In the intravenous administration cohorts, doses ranged from 0.03 mg to 1.5 mg.
    Summary · context
    The subcutaneous administration cohort received the approved 0.6 mg dose.
  8. 08HumanRandomized controlled trialSafety outcome

    In healthy volunteers, the treatment effect-specific intercept was -0.44 ms, with a 90% CI of -2.37 to 1.49 ms.

    In plain wordsIn healthy volunteers, the dasiglucagon treatment effect-specific intercept was -0.44 ms.

    Peptide
    Dasiglucagon
    Outcome
    Not applicableTreatment effect-specific intercept
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    0.03-1.5 mg · intravenousAs given in this study (human).

    Measurements

    Treatment effect-specific intercept
    −0.44 ms
    QT model
    90% CI
    −2.37 to 1.49 ms
    intercept

    Source sentences

    Summary
    The treatment effect-specific intercept was -0.44 ms (90% CI, -2.37 to 1.49 ms).
    4 context sentences
    Summary · context
    This double-blind, placebo-controlled, dose-escalation Phase I trial was conducted at a single center in Germany between November 2018 and June 2019.
    Summary · context
    Sixty healthy volunteers aged 18 to 45 years were randomized within dose cohorts to receive intravenous dasiglucagon, intravenous placebo, or subcutaneous dasiglucagon.
    Summary · context
    In the intravenous administration cohorts, doses ranged from 0.03 mg to 1.5 mg.
    Summary · context
    The subcutaneous administration cohort received the approved 0.6 mg dose.

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT03735225

Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration

Zealand Pharman = 607 Nov 2018 to 24 Jun 2019

Hypoglycemia

Trial pageClinicalTrials.govUpdated 23 Mar 2021

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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