Trial · NCT03378635

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

NCT03378635, Phase 3, Completed, Zealand Pharma; results first posted 2021-05-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects. Trials, record NCT03378635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03378635

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects
NCT number: NCT03378635
Status: Completed
Phases: Phase 3
Enrollment: 170 participants, actual
Lead sponsor: Zealand Pharma
Conditions: Hypoglycemia, Diabetes Mellitus, Type 1
Interventions: Dasiglucagon, GlucaGen, Placebo
First posted: 2017-12-20
Last updated: 2021-06-10
Results first posted: 2021-05-10

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Plasma Glucose Recovery	0-45 minutes after dosing	Plasma glucose recovery is defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose. The outcome measure used a Kaplan-Meier estimate with 95% confidence interval. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.
Secondary	Plasma Glucose Recovery	0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection	Plasma glucose recovery within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after study drug injection without administration of rescue IV glucose. Plasma glucose recovery was defined as the first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose.
Secondary	Plasma Glucose Changes From Baseline	0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection	Plasma glucose changes from baseline at 30 minutes, 20 minutes, 15 minutes and 10 minutes after study drug injection without administration of rescue intravenous glucose
Secondary	Time to Target	0-45 minutes after dosing	Time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) without administration of rescue intravenous glucose. The outcome measure used a Kaplan-Meier estimate with 95% confidence interval. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.
Secondary	Pharmacodynamics - Area Under the Effect Curve	0-30 minutes after dosing	Plasma glucose response as area under the effect curve (AUE) above baseline from time zero to 30 minutes. Samples were collected pre-dose, and at 4, 6, 8, 10, 12, 15, 17, 20, 25 and 30 minutes after dosing.
Secondary	Pharmacokinetics - Area Under the Plasma Concentration Curve	0-90 minutes after dosing	Area under the drug concentration curve from time zero to 90 minutes, AUC0-90min. To calculate the AUC the standard trapezoidal method was used, based on actual rather than nominal time points. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.
Secondary	Pharmacokinetics - Area Under the Plasma Concentration Curve	0-120 minutes after dosing	Area under the drug concentration curve from time zero to 120 minutes, AUC0-120min. To calculate the AUC the standard trapezoidal method was used, based on actual rather than nominal time points. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.
Secondary	Pharmacokinetics - Maximum Plasma Concentration	0-120 minutes after dosing	Maximum plasma drug concentration (Cmax). Maximum plasma drug concentration was determined as the maximum of all valid plasma dasiglucagon/glucagon concentrations. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.
Secondary	Pharmacokinetics - Time to Maximum Plasma Concentration	0-120 minutes after dosing	Time to maximum plasma drug concentration (tmax). Median Tmax was determined as the time point where the maximum of all valid plasma dasiglucagon/glucagon concentration measurements for each measurement series was observed. Samples were collected pre-dose, and at 15, 30, 35, 40, 50, 60, 90 and 120 minutes after dosing.
Secondary	Immunogenicity - Occurence of Anti-drug Antibodies	28 days	Occurence of antibodies against dasiglucagon/GlucaGen

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Plasma Glucose Recovery	0-45 minutes after dosing	Full analysis set of all randomized patients who received at least one dose of trial product	minutes	MEDIAN
SECONDARY	Plasma Glucose Recovery	0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection	Full analysis set of all randomized patients who received at least one dose of trial product	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Plasma Glucose Changes From Baseline	0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection	Full analysis set of all randomized patients who received at least one dose of trial product	mg/dL	MEAN
SECONDARY	Time to Target	0-45 minutes after dosing	Full analysis set of all randomized patients who received at least one dose of trial product	minutes	MEDIAN
SECONDARY	Pharmacodynamics - Area Under the Effect Curve	0-30 minutes after dosing	Full analysis set of all randomized patients who received at least one dose of trial product	mg*h/dL	MEAN
SECONDARY	Pharmacokinetics - Area Under the Plasma Concentration Curve	0-90 minutes after dosing	Full analysis set of all randomized patients who received at least one dose of trial product. No results are presented for the placebo group, as no active drug was given in this group.	pmol*h/L	GEOMETRIC_MEAN
SECONDARY	Pharmacokinetics - Area Under the Plasma Concentration Curve	0-120 minutes after dosing	Full analysis set of all randomized patients who received at least one dose of trial product. No results are presented for the placebo group, as no active drug was given in this group.	pmol*h/L	GEOMETRIC_MEAN
SECONDARY	Pharmacokinetics - Maximum Plasma Concentration	0-120 minutes after dosing	Full analysis set of all randomized patients who received at least one dose of trial product. No results are presented for the placebo group, as no active drug was given in this group.	pmol/L	GEOMETRIC_MEAN
SECONDARY	Pharmacokinetics - Time to Maximum Plasma Concentration	0-120 minutes after dosing	Full analysis set of all randomized patients who received at least one dose of trial product. No results are presented for the placebo group, as no active drug was given in this group.	hours	MEDIAN
SECONDARY	Immunogenicity - Occurence of Anti-drug Antibodies	28 days	The safety analysis set of all randomized patients who received trial medication (which was the same as the full analysis set)	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Time to Plasma Glucose Recovery	Dasiglucagon 0.6 mg		10	95% Confidence Interval 10 to 10	minutes
Time to Plasma Glucose Recovery	Placebo		40	95% Confidence Interval 30 to 40	minutes
Time to Plasma Glucose Recovery	GlucaGen® 1.0 mg		12	95% Confidence Interval 10 to 12	minutes
Plasma Glucose Recovery	Dasiglucagon 0.6 mg	Glucose recovery at 30 minutes	82		Participants
Plasma Glucose Recovery	Placebo	Glucose recovery at 30 minutes	20		Participants
Plasma Glucose Recovery	GlucaGen® 1.0 mg	Glucose recovery at 30 minutes	43		Participants
Plasma Glucose Recovery	Dasiglucagon 0.6 mg	Glucose recovery at 20 minutes	81		Participants
Plasma Glucose Recovery	Placebo	Glucose recovery at 20 minutes	6		Participants
Plasma Glucose Recovery	GlucaGen® 1.0 mg	Glucose recovery at 20 minutes	42		Participants
Plasma Glucose Recovery	Dasiglucagon 0.6 mg	Glucose recovery at 15 minutes	81		Participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dasiglucagon 0.6 mg	84
Overall Study	STARTED	Placebo	43
Overall Study	STARTED	GlucaGen® 1.0 mg	43
Overall Study	Randomized and Exposed to Treatment	Dasiglucagon 0.6 mg	82
Overall Study	Randomized and Exposed to Treatment	Placebo	43
Overall Study	Randomized and Exposed to Treatment	GlucaGen® 1.0 mg	43
Overall Study	COMPLETED	Dasiglucagon 0.6 mg	82
Overall Study	COMPLETED	Placebo	43
Overall Study	COMPLETED	GlucaGen® 1.0 mg	43
Overall Study	NOT COMPLETED	Dasiglucagon 0.6 mg	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events120

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Dasiglucagon 0.6 mg	10	82	10
other	Headache	Nervous system disorders	Placebo	2	43	2
other	Headache	Nervous system disorders	GlucaGen® 1.0 mg	5	43	5
other	Nausea	Gastrointestinal disorders	Dasiglucagon 0.6 mg	45	82	46
other	Nausea	Gastrointestinal disorders	Placebo	1	43	1
other	Nausea	Gastrointestinal disorders	GlucaGen® 1.0 mg	23	43	24
other	Vomiting	Gastrointestinal disorders	Dasiglucagon 0.6 mg	19	82	25
other	Vomiting	Gastrointestinal disorders	Placebo	1	43	1
other	Vomiting	Gastrointestinal disorders	GlucaGen® 1.0 mg	9	43	11
other	Hypoglycemia	Metabolism and nutrition disorders	Dasiglucagon 0.6 mg	23	82	39

1 to 10 of 120Source ClinicalTrials.gov

See all 120 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dasiglucagon 0.6 mg	0	82
Total, all-cause mortality	Placebo	0	43
Total, all-cause mortality	GlucaGen® 1.0 mg	0	43
Total, other adverse events	Dasiglucagon 0.6 mg	66	82
Total, other adverse events	Placebo	14	43
Total, other adverse events	GlucaGen® 1.0 mg	32	43
Total, serious adverse events	Dasiglucagon 0.6 mg	0	82
Total, serious adverse events	Placebo	0	43
Total, serious adverse events	GlucaGen® 1.0 mg	0	43

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35239971	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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