Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial.

Pieber TR, Aronson R, Hövelmann U, Willard J, Plum-Mörschel L, Knudsen KM, Bandak B, Tehranchi R

Diabetes care1 Jun 2021Cited by 42 (Europe PMC)

PMID35239971PMCIDPMC8247529DOI10.2337/dc20-2995PepBankPUB-35239971

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, median recovery time was 10 (95% CI 10, 10) minutes with dasiglucagon versus 40 (30, 40) with placebo (P < 0.001).
In plain wordsDasiglucagon restored glucose faster than placebo.
Peptide
Dasiglucagon
Outcome
DecreaseRecovery time versus placebo
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 recovery
10 minutes
dasiglucagon 0.6 mg; 95% CI 10-10
Median time to recovery
40 minutes
placebo; 95% CI 30-40
Source sentences
Summary
Median (95% CI) time to recovery was 10 (10, 10) minutes for dasiglucagon compared with 40 (30, 40) minutes for placebo (P < 0.001); the corresponding result for reconstituted glucagon was 12 (10, 12) minutes.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, double-blind trial included 170 adult participants with type 1 diabetes, each randomly assigned to receive a single subcutaneous dose of 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon (2:1:1 randomization) during controlled insulin-induced hypoglycemia.
Report a problemFND-3523997101
02HumanRandomized controlled trialEfficacy outcome
Recovery within 15 min occurred in 99% with dasiglucagon versus 2% with placebo (P < 0.001).
In plain wordsMore participants recovered within 15 minutes with dasiglucagon than placebo.
Peptide
Dasiglucagon
Outcome
IncreaseRecovery within 15 minutes versus placebo
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
Recovery within 15 minutes
99%
dasiglucagon 0.6 mg
Recovery within 15 minutes
2%
placebo
Source sentences
Summary
In the dasiglucagon group, plasma glucose recovery was achieved within 15 min in all but one participant (99%), superior to placebo (2%; P < 0.001) and similar to glucagon (95%).
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, double-blind trial included 170 adult participants with type 1 diabetes, each randomly assigned to receive a single subcutaneous dose of 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon (2:1:1 randomization) during controlled insulin-induced hypoglycemia.
Report a problemFND-3523997103
03HumanRandomized controlled trialEfficacy outcome
Recovery within 15 min was similar with dasiglucagon (99%) and glucagon (95%).
In plain wordsRecovery within 15 minutes was similar with dasiglucagon and glucagon.
Peptide
Dasiglucagon
Outcome
Not applicableRecovery within 15 minutes versus glucagon
Study
n: not reported in source
Comparator
Glucagon
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.6 mg · subcutaneousAs given in this study (human).
Measurements
Recovery within 15 minutes
99%
dasiglucagon 0.6 mg
Recovery within 15 minutes
95%
reconstituted glucagon
Source sentences
Summary
In the dasiglucagon group, plasma glucose recovery was achieved within 15 min in all but one participant (99%), superior to placebo (2%; P < 0.001) and similar to glucagon (95%).
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, double-blind trial included 170 adult participants with type 1 diabetes, each randomly assigned to receive a single subcutaneous dose of 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon (2:1:1 randomization) during controlled insulin-induced hypoglycemia.
Report a problemFND-3523997104
04HumanRandomized controlled trialEfficacy outcome
Recovery within 15 min was similar with glucagon (95%) and dasiglucagon (99%).
In plain wordsRecovery within 15 minutes was similar with glucagon and dasiglucagon.
Peptide
Glucagon
Outcome
Not applicableRecovery within 15 minutes versus dasiglucagon
Study
n: not reported in source
Comparator
Dasiglucagon
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1 mg · subcutaneousAs given in this study (human).
Measurements
Recovery within 15 minutes
95%
reconstituted glucagon 1 mg
Recovery within 15 minutes
99%
dasiglucagon 0.6 mg
Source sentences
Summary
In the dasiglucagon group, plasma glucose recovery was achieved within 15 min in all but one participant (99%), superior to placebo (2%; P < 0.001) and similar to glucagon (95%).
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, double-blind trial included 170 adult participants with type 1 diabetes, each randomly assigned to receive a single subcutaneous dose of 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon (2:1:1 randomization) during controlled insulin-induced hypoglycemia.
Report a problemFND-3523997105
05HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, similar outcomes were observed for the other time points, 10, 20 and 30 minutes after dosing.
In plain wordsSimilar outcomes were seen at 10, 20 and 30 minutes after dosing.
Peptide
Dasiglucagon
Outcome
Direction not reportedRecovery at other time points
Study
n: not reported in source
Comparator
Placebo and reconstituted glucagon, separately
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.6 mg · subcutaneousAs given in this study (human).
Source sentences
Summary
Similar outcomes were observed for the other investigated time points at 10, 20, and 30 min after dosing.
2 context sentences(design, population, supporting numbers)
Summary · context
In the dasiglucagon group, plasma glucose recovery was achieved within 15 min in all but one participant (99%), superior to placebo (2%; P < 0.001) and similar to glucagon (95%).
Summary · context
This randomized, double-blind trial included 170 adult participants with type 1 diabetes, each randomly assigned to receive a single subcutaneous dose of 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon (2:1:1 randomization) during controlled insulin-induced hypoglycemia.
Report a problemFND-3523997106
06HumanNon-randomized trialEfficacy outcome
In adults with type 1 diabetes, reconstituted glucagon produced median recovery time of 12 (95% CI 10, 12) minutes.
In plain wordsGlucagon restored glucose in a median 12 minutes.
Peptide
Glucagon
Outcome
Not applicableRecovery time
Study
n: not reported in source
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1 mg · subcutaneousAs given in this study (human).
Measurements
Median time to recovery
12 minutes
reconstituted glucagon 1 mg; 95% CI 10-12
Source sentences
Summary
Median (95% CI) time to recovery was 10 (10, 10) minutes for dasiglucagon compared with 40 (30, 40) minutes for placebo (P < 0.001); the corresponding result for reconstituted glucagon was 12 (10, 12) minutes.
1 context sentence(design, population, supporting numbers)
Summary · context
This randomized, double-blind trial included 170 adult participants with type 1 diabetes, each randomly assigned to receive a single subcutaneous dose of 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon (2:1:1 randomization) during controlled insulin-induced hypoglycemia.
Report a problemFND-3523997102

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03378635

A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects

Zealand Pharman = 1707 Dec 2017 to 25 May 2018

Hypoglycemia · Diabetes Mellitus, Type 1

Trial page ClinicalTrials.govUpdated 10 Jun 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.

Version 3Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 2
27 Oct 2026, 16:35 UTC
Study data updated · source update from Europe PMC
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC