Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial.

Laugesen C, Ranjan AG, Schmidt S, Nørgaard K

Diabetologia11 Apr 2023Cited by 2 (Europe PMC)

PMID37037948PMCIDPMC10244275DOI10.1007/s00125-023-05909-4PepBankPUB-37037948

Summary

Aims/hypothesisConsumption of excess carbohydrates to manage hypoglycaemia can lead to rebound hyperglycaemia and promote weight gain. The objective of this trial was to evaluate the efficacy, safety and feasibility of pen-administered low-dose dasiglucagon for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions.MethodsTwenty-four adults with insulin pump-treated type 1 diabetes (HbA_1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods. During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively. Glycaemic control was evaluated using continuous glucose monitoring (Dexcom G6) and event registration of prevention and treatment episodes.ResultsCompared with usual care, the mean difference (95% CI) in the DASI period for time in (3.9-10.0 mmol/l) and below (<3.9 mmol/l) range was 2.4 %-points (-0.7, 5.5) and -0.5 %-points (-1.2, 0.2), respectively. In the DASI period, recovery rate (time from hypoglycaemia treatment to euglycaemia) was 44% (11, 87) faster while total daily carbohydrate intake was reduced by 11% (-18, -3). Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect. Among the participants, 96% (p<0.0001) were likely to include dasiglucagon in their future routine management of hypoglycaemia.Conclusions/interpretationUse of low-dose dasiglucagon to prevent and treat non-severe hypoglycaemia during free-living conditions was safe, fast and efficacious while significantly reducing the total daily carbohydrate intake and yielding high treatment satisfaction.Trial registrationClinicalTrials.gov NCT04764968 FUNDING: The study was an investigator-initiated trial. Zealand Pharma supplied the investigational drug and device and provided financial support for the conduct of the trial.

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.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, dasiglucagon changed time in range by 2.4 percentage points versus usual care, with a 95% CI of -0.7 to 5.5.
In plain wordsIn adults with type 1 diabetes, dasiglucagon did not significantly change time in glucose range compared with usual care.
Peptide
Dasiglucagon
Outcome
No significant changeTime in glucose range
Study
n = 24
Comparator
Usual care with carbohydrate consumption
Outcome group
Glycemic control · Metabolic and weight
Studied dose
80 μg · subcutaneous · 2 weeksAs given in this study (human).
Measurements
Time in range difference
2.4 percentage points
3.9-10.0 mmol/l
95% CI
−0.7 to 5.5 percentage points
time in range difference
Source sentences
Summary
Compared with usual care, the mean difference (95% CI) in the DASI period for time in (3.9-10.0 mmol/l) and below (<3.9 mmol/l) range was 2.4 %-points (-0.7, 5.5) and -0.5 %-points (-1.2, 0.2), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Twenty-four adults with insulin pump-treated type 1 diabetes (HbA_1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods.
Summary · context
During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively.
Show in the study text Report a problemFND-3703794801
02HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, dasiglucagon changed time below range by -0.5 percentage points versus usual care, with a 95% CI of -1.2 to 0.2.
In plain wordsIn adults with type 1 diabetes, dasiglucagon did not significantly change time below glucose range compared with usual care.
Peptide
Dasiglucagon
Outcome
No significant changeTime below glucose range
Study
n = 24
Comparator
Usual care with carbohydrate consumption
Outcome group
Glycemic control · Metabolic and weight
Studied dose
80 μg · subcutaneous · 2 weeksAs given in this study (human).
Measurements
Time below range difference
−0.5 percentage points
<3.9 mmol/l
95% CI
−1.2 to 0.2 percentage points
time below range difference
Source sentences
Summary
Compared with usual care, the mean difference (95% CI) in the DASI period for time in (3.9-10.0 mmol/l) and below (<3.9 mmol/l) range was 2.4 %-points (-0.7, 5.5) and -0.5 %-points (-1.2, 0.2), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Twenty-four adults with insulin pump-treated type 1 diabetes (HbA_1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods.
Summary · context
During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively.
Show in the study text Report a problemFND-3703794802
03HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, recovery from hypoglycemia was 44% faster with dasiglucagon than usual care, with a reported interval of 11 to 87.
In plain wordsIn adults with type 1 diabetes, recovery from hypoglycemia was 44% faster with dasiglucagon than usual care.
Peptide
Dasiglucagon
Outcome
IncreaseRecovery rate
Study
n = 24
Comparator
Usual care with carbohydrate consumption
Outcome group
Glycemic control · Metabolic and weight
Studied dose
80 μg · subcutaneous · 2 weeksAs given in this study (human).
Measurements
Faster recovery
44%
dasiglucagon versus usual care
Reported interval
11 to 87%
faster recovery
Source sentences
Summary
In the DASI period, recovery rate (time from hypoglycaemia treatment to euglycaemia) was 44% (11, 87) faster while total daily carbohydrate intake was reduced by 11% (-18, -3).
2 context sentences(design, population, supporting numbers)
Summary · context
Twenty-four adults with insulin pump-treated type 1 diabetes (HbA_1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods.
Summary · context
During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively.
Show in the study text Report a problemFND-3703794803
04HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, dasiglucagon reduced daily carbohydrate intake by 11% versus usual care, with a reported interval of -18 to -3.
In plain wordsIn adults with type 1 diabetes, dasiglucagon reduced daily carbohydrate intake by 11% compared with usual care.
Peptide
Dasiglucagon
Outcome
DecreaseDaily carbohydrate intake
Study
n = 24
Comparator
Usual care with carbohydrate consumption
Outcome group
Appetite and food intake · Metabolic and weight
Studied dose
80 μg · subcutaneous · 2 weeksAs given in this study (human).
Measurements
Carbohydrate intake reduction
11%
versus usual care
Reported interval
−18 to −3%
carbohydrate intake change
Source sentences
Summary
In the DASI period, recovery rate (time from hypoglycaemia treatment to euglycaemia) was 44% (11, 87) faster while total daily carbohydrate intake was reduced by 11% (-18, -3).
2 context sentences(design, population, supporting numbers)
Summary · context
Twenty-four adults with insulin pump-treated type 1 diabetes (HbA_1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods.
Summary · context
During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively.
Show in the study text Report a problemFND-3703794804
05HumanNon-randomized trialSafety outcome
In adults with type 1 diabetes, low-dose dasiglucagon was safe and well tolerated.
In plain wordsIn adults with type 1 diabetes, low-dose dasiglucagon was safe and well tolerated.
Peptide
Dasiglucagon
Outcome
Not applicableOverall safety and tolerability
Study
n = 24
Outcome group
Adverse events · Whole body
Studied dose
80 μg · subcutaneous · 2 weeksAs given in this study (human).
Source sentences
Summary
Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect.
2 context sentences(design, population, supporting numbers)
Summary · context
Twenty-four adults with insulin pump-treated type 1 diabetes (HbA_1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods.
Summary · context
During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively.
Show in the study text Report a problemFND-3703794805
06HumanNon-randomized trialSafety outcome
In adults with type 1 diabetes, mild nausea was the most frequent adverse effect of dasiglucagon.
In plain wordsIn adults with type 1 diabetes, mild nausea was the most frequent adverse effect of dasiglucagon.
Peptide
Dasiglucagon
Outcome
Not applicableMild nausea
Study
n = 24
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
80 μg · subcutaneous · 2 weeksAs given in this study (human).
Source sentences
Summary
Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect.
2 context sentences(design, population, supporting numbers)
Summary · context
Twenty-four adults with insulin pump-treated type 1 diabetes (HbA_1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods.
Summary · context
During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively.
Show in the study text Report a problemFND-3703794806
07HumanNon-randomized trialOther
Among adults with type 1 diabetes, 96% were likely to include dasiglucagon in future routine hypoglycemia management, p<0.0001.
In plain wordsAmong adults with type 1 diabetes, 96% were likely to use dasiglucagon for future routine hypoglycemia management.
Peptide
Dasiglucagon
Outcome
Not applicableIntention to use dasiglucagon
Study
n = 24
Outcome group
Treatment Acceptability · Whole body
Studied dose
80 μg · subcutaneous · 2 weeksAs given in this study (human).
Measurements
Likely future use
96%
participants
Source sentences
Summary
Among the participants, 96% (p<0.0001) were likely to include dasiglucagon in their future routine management of hypoglycaemia.
2 context sentences(design, population, supporting numbers)
Summary · context
Twenty-four adults with insulin pump-treated type 1 diabetes (HbA_1c ≤70 mmol/mol [8.5%]) completed a randomised, open-label, two-period crossover study with 2 week periods.
Summary · context
During the usual care and dasiglucagon intervention (DASI) periods, participants managed impending and manifested episodes of hypoglycaemia with regular carbohydrate consumption or pen-administered low-dose (80 μg) s.c. dasiglucagon, respectively.
Show in the study text Report a problemFND-3703794807

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 2NCT04764968

Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes

Steno Diabetes Center Copenhagenn = 2427 Apr 2021 to 28 Jan 2022

Type 1 Diabetes · Hypoglycemia

Trial page ClinicalTrials.govUpdated 7 Sept 2022

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 2Current
28 Oct 2026, 02:03 UTC
Study results updated
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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