Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM

• Sponsor: Zealand Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03688711
• Collaborator: (none)
• Enrollment: 45
• Locations: 3
• Arms: 2
• Actual Duration (Months): 4.3
• Patients Per Site: 15
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo

Condition or Disease	Intervention/Treatment	Phase
Hypoglycemia; Diabetes Mellitus, Type 1	Drug: Dasiglucagon; Drug: Placebo	Phase 3

Detailed Description

Subjects were randomized in a ratio of 3:1 to receive a single subcutaneous dose of dasiglucagon (0.6 mg) or matching placebo. Randomization also determined whether the subject was to be injected in the buttock or deltoid. During the dosing visit (Visit 2), hypoglycemia was induced by a fast-acting insulin glulisine (Apidra®) infusion, and trial drug was administered when the subject's plasma glucose level was 45-60 mg/dL (2.5-3.3 mmol/L). During the insulin-induced hypoglycemia, pharmacokinetic and pharmacodynamic samples were drawn, and plasma glucose levels were monitored closely at site for safety reasons. A rescue glucose infusion could be administered to ameliorate persistent hypoglycemia. Subjects were followed for at least 28 days after dosing to perform an adequate immunogenicity evaluation of treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Parallel-group Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Rescue Treatment of Hypoglycemia in Subjects With Type 1 Diabetes Mellitus (T1DM) Compared to Placebo
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: Mar 11, 2019
• Actual Study Completion Date: Mar 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dasiglucagon single fixed dose (subcutaneous injection) of dasiglucagon	Drug: Dasiglucagon; Glucagon analogue; Other Names: ZP4207
Placebo Comparator: Placebo single fixed dose (subcutaneous injection) of placebo	Drug: Placebo; Placebo for dasiglucagon; Other Names: Placebo for dasiglucagon

Outcome Measures

Primary Outcome Measures

1. Time to Plasma Glucose Recovery. [0-45 minutes after dosing]

   Plasma glucose recovery was defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous (IV) glucose. Patients who received rescue IV glucose before 45 minutes and patients not recovering within 45 minutes after dosing were censored at 45 minutes.

Secondary Outcome Measures

1. Plasma Glucose Recovery After Trial Drug Injection [0-30 minutes after dosing]

   Plasma glucose recovery (patient has achieved increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L)) within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after trial drug injection without administration of rescue intravenous (IV) glucose.

2. Plasma Glucose Changes From Baseline [0-30 minutes after dosing]

   Plasma glucose changes from baseline at 30 minutes, at 20 minutes, at 15 minutes, and at 10 minutes after trial drug injection or at the time of rescue (patient level).

3. Time to Target Plasma Glucose Concentration [0-45 minutes after dosing]

   Time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) without administration of rescue intravenous glucose

4. 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, AUE0-30min.

5. Pharmacokinetics - Area Under the Plasma Concentration Curve [0-90 minutes after dosing]

   Area under the drug concentration curve (AUC) from time zero to 90 minutes, AUC0-90min

6. Pharmacokinetics - Area Under the Plasma Concentration Curve [0-120 minutes after dosing]

   Area under the drug concentration curve (AUC) from time zero to 120 minutes, AUC0-120min

7. Pharmacokinetics - Maximum Plasma Concentration [0-120 minutes after dosing]

   Maximum plasma dasiglucagon concentration (Cmax)

8. Pharmacokinetics - Time to Maximum Plasma Concentration [0-120 minutes after dosing]

   Time to maximum plasma dasiglucagon concentration (tmax)

9. Immunogenicity - Occurrence of Anti-drug Antibodies [58 days]

   Occurrence of antibodies against dasiglucagon. Presented as percentage of patients with antibodies.

10. Rescue Infusions of IV Glucose After Trial Drug Administration [0-45 minutes after dosing]

    Presented as number of patients with rescue infusions of IV glucose after trial drug administration. This was a safety outcome measure. IV = intravenous

11. Time to First Rescue Infusion of IV Glucose After Trial Drug Administration [0-45 minutes after dosing]

    Safety outcome measure: time to first rescue infusion of IV glucose after trial drug administration. IV = intravenous

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined by the American Diabetes Association (3).

• Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening

• Hemoglobin A1c <10%.

• Aged between 18 and 75 years, both inclusive.

Exclusion Criteria:

• Previous participation in a clinical trial within the dasiglucagon in the rescue treatment of hypoglycemia program.

• Known or suspected allergy to trial drug(s) or related products.

• History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).

• Previous participation in this trial. Participation being defined by signing the informed consent document.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProSciento, Inc.	Chula Vista	California	United States	91911
2	AMCR Institute	Escondido	California	United States	92025
3	Rainier Clinical Research, Inc.	Renton	Washington	United States	98057

Sponsors and Collaborators

• Zealand Pharma

Investigators

• Study Director: Christina M Sylvest, MSc Pharm, Zealand Pharma A/S

Study Documents (Full-Text)

• Study Protocol - Jul 4, 2018
• Statistical Analysis Plan - Apr 24, 2019

More Information

Publications

None provided.

• Responsible Party: Zealand Pharma
• ClinicalTrials.gov Identifier: NCT03688711
• Other Study ID Numbers: ZP4207-17145
• First Posted: Sep 28, 2018
• Last Update Posted: May 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zealand Pharma: glucagon
• Additional relevant MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1

Study Results

Participant Flow

Arm/Group Title	Dasiglucagon 0.6 mg	Placebo
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue	single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon
Period Title: Overall Study
STARTED	34	11
COMPLETED	34	10
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Dasiglucagon 0.6 mg	Placebo	Total
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue	single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon	Total of all reporting groups
Overall Participants	34	10	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.4 (13.49)	36.5 (12.80)	41.0 (13.42)
Sex: Female, Male (Count of Participants)
Female	18 52.9%	1 10%	19 43.2%
Male	16 47.1%	9 90%	25 56.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 11.8%	3 30%	7 15.9%
Not Hispanic or Latino	30 88.2%	7 70%	37 84.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	1 10%	1 2.3%
Black or African American	0 0%	1 10%	1 2.3%
White	34 100%	7 70%	41 93.2%
More than one race	0 0%	1 10%	1 2.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	34 100%	10 100%	44 100%
Body weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	84.49 (20.102)	83.69 (10.812)	84.30 (18.295)
Body mass index (kg per square metre) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg per square metre]	28.41 (5.802)	27.92 (3.975)	28.30 (5.402)
Duration of diabetes (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.5 (13.82)	21.2 (13.42)	22.2 (13.59)

Outcome Measures

1. Primary Outcome

Title	Time to Plasma Glucose Recovery.
Description	Plasma glucose recovery was defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous (IV) glucose. Patients who received rescue IV glucose before 45 minutes and patients not recovering within 45 minutes after dosing were censored at 45 minutes.
Time Frame	0-45 minutes after dosing

Outcome Measure Data

Analysis Population Description

The full analysis set of all randomized subjects who received at least one dose of trial drug (same as the safety analysis set)

Arm/Group Title	Dasiglucagon 0.6 mg	Placebo
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue	single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon
Measure Participants	34	10
Median (95% Confidence Interval) [minutes]	10.0	35.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dasiglucagon 0.6 mg, Placebo
	Comments	The recovery rates of dasiglucagon and placebo were evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests stratified by injection site.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Log Rank
	Comments

2. Secondary Outcome

Title	Plasma Glucose Recovery After Trial Drug Injection
Description	Plasma glucose recovery (patient has achieved increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L)) within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after trial drug injection without administration of rescue intravenous (IV) glucose.
Time Frame	0-30 minutes after dosing

Outcome Measure Data

Analysis Population Description

The full analysis set of all randomized subjects who received at least one dose of trial drug (same as the safety analysis set)

Arm/Group Title	Dasiglucagon 0.6 mg	Placebo
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue	single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon
Measure Participants	34	10
Glucose recovery within 30 minutes	33 97.1%	5 50%
Glucose recovery within 20 minutes	32 94.1%	1 10%
Glucose recovery within 15 minutes	30 88.2%	0 0%
Glucose recovery within 10 minutes	21 61.8%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dasiglucagon 0.6 mg, Placebo
	Comments	Assessed at 30 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Dasiglucagon 0.6 mg, Placebo
	Comments	Assessed at 20 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Dasiglucagon 0.6 mg, Placebo
	Comments	Assessed at 15 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Fisher Exact
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Dasiglucagon 0.6 mg, Placebo
	Comments	Assessed at 10 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Plasma Glucose Changes From Baseline
Description	Plasma glucose changes from baseline at 30 minutes, at 20 minutes, at 15 minutes, and at 10 minutes after trial drug injection or at the time of rescue (patient level).
Time Frame	0-30 minutes after dosing

Outcome Measure Data

Analysis Population Description

The full analysis set of all randomized subjects who received at least one dose of trial drug (same as the safety analysis set)

Arm/Group Title	Dasiglucagon 0.6 mg	Placebo
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue	single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon
Measure Participants	34	10
At 30 minutes	85.29 (29.696)	15.14 (9.328)
At 20 minutes	52.95 (20.298)	9.67 (8.846)
At 15 minutes	41.62 (17.077)	5.23 (6.686)
At 10 minutes	24.54 (12.560)	0.62 (6.100)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dasiglucagon 0.6 mg, Placebo
	Comments	Change from baseline in plasma glucose at 30 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Dasiglucagon 0.6 mg, Placebo
	Comments	Change from baseline in plasma glucose at 20 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Dasiglucagon 0.6 mg, Placebo
	Comments	Change from baseline in plasma glucose at 15 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Dasiglucagon 0.6 mg, Placebo
	Comments	Change from baseline in plasma glucose at 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Time to Target Plasma Glucose Concentration
Description	Time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) without administration of rescue intravenous glucose
Time Frame	0-45 minutes after dosing

Outcome Measure Data

Analysis Population Description

The full analysis set of all randomized subjects who received at least one dose of trial drug (same as the safety analysis set)

Arm/Group Title	Dasiglucagon 0.6 mg	Placebo
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue	single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon
Measure Participants	34	10
Median (95% Confidence Interval) [minutes]	9.0	27.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dasiglucagon 0.6 mg, Placebo
	Comments	Evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor, analogous to that used for the primary endpoint analysis. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests. Subjects whose time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) was not met within 45 minutes post-dosing were censored, at the time of the last valid plasma glucose measurement up to 45 minutes.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Log Rank
	Comments

5. Secondary Outcome

Title	Pharmacodynamics - Area Under the Effect Curve
Description	Plasma glucose response as area under the effect curve (AUE) above baseline from time zero to 30 minutes, AUE0-30min.
Time Frame	0-30 minutes after dosing

Outcome Measure Data

Analysis Population Description

The full analysis set of all randomized subjects who received at least one dose of trial drug (same as the safety analysis set)

Arm/Group Title	Dasiglucagon 0.6 mg	Placebo
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue	single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon
Measure Participants	34	10
Mean (Standard Deviation) [hr*mg/dL]	19.9 (8.41)	2.67 (3.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dasiglucagon 0.6 mg, Placebo
	Comments	The analysis was an analysis of covariance (ANCOVA) model with treatment group as factor and the baseline of the dependent variable plasma glucose as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.05
	Confidence Interval	(2-Sided) 95%; 2.71 to 6.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Pharmacokinetics - Area Under the Plasma Concentration Curve
Description	Area under the drug concentration curve (AUC) from time zero to 90 minutes, AUC0-90min
Time Frame	0-90 minutes after dosing

Outcome Measure Data

Analysis Population Description

The full analysis set of all randomized subjects who received at least one dose of trial drug (same as the safety analysis set)

Arm/Group Title	Dasiglucagon 0.6 mg
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue
Measure Participants	34
Geometric Mean (Geometric Coefficient of Variation) [hr*pmol/L]	1480 (34.6)

7. Secondary Outcome

Title	Pharmacokinetics - Area Under the Plasma Concentration Curve
Description	Area under the drug concentration curve (AUC) from time zero to 120 minutes, AUC0-120min
Time Frame	0-120 minutes after dosing

Outcome Measure Data

Analysis Population Description

The full analysis set of all randomized subjects who received at least one dose of trial drug (same as the safety analysis set)

Arm/Group Title	Dasiglucagon 0.6 mg
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue
Measure Participants	34
Geometric Mean (Geometric Coefficient of Variation) [hr*pmol/L]	1780 (31.6)

8. Secondary Outcome

Title	Pharmacokinetics - Maximum Plasma Concentration
Description	Maximum plasma dasiglucagon concentration (Cmax)
Time Frame	0-120 minutes after dosing

Outcome Measure Data

Analysis Population Description

The full analysis set of all randomized subjects who received at least one dose of trial drug (same as the safety analysis set)

Arm/Group Title	Dasiglucagon 0.6 mg
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue
Measure Participants	34
Geometric Mean (Geometric Coefficient of Variation) [pmol/L]	1350 (38.2)

9. Secondary Outcome

Title	Pharmacokinetics - Time to Maximum Plasma Concentration
Description	Time to maximum plasma dasiglucagon concentration (tmax)
Time Frame	0-120 minutes after dosing

Outcome Measure Data

Analysis Population Description

The full analysis set of all randomized subjects who received at least one dose of trial drug (same as the safety analysis set)

Arm/Group Title	Dasiglucagon 0.6 mg
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue
Measure Participants	34
Median (Full Range) [minutes]	35

10. Secondary Outcome

Title	Immunogenicity - Occurrence of Anti-drug Antibodies
Description	Occurrence of antibodies against dasiglucagon. Presented as percentage of patients with antibodies.
Time Frame	58 days

Outcome Measure Data

Analysis Population Description

The safety analysis set of all randomized subjects who received at least one dose of trial drug (same as the full analysis set)

Arm/Group Title	Dasiglucagon 0.6 mg	Placebo
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue	single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon
Measure Participants	34	10
Count of Participants [Participants]	0 0%	0 0%

11. Secondary Outcome

Title	Rescue Infusions of IV Glucose After Trial Drug Administration
Description	Presented as number of patients with rescue infusions of IV glucose after trial drug administration. This was a safety outcome measure. IV = intravenous
Time Frame	0-45 minutes after dosing

Outcome Measure Data

Analysis Population Description

The full analysis set of all randomized subjects who received at least one dose of trial drug (same as the safety analysis set)

Arm/Group Title	Dasiglucagon 0.6 mg	Placebo
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue	single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon
Measure Participants	34	10
Count of Participants [Participants]	1 2.9%	1 10%

12. Secondary Outcome

Title	Time to First Rescue Infusion of IV Glucose After Trial Drug Administration
Description	Safety outcome measure: time to first rescue infusion of IV glucose after trial drug administration. IV = intravenous
Time Frame	0-45 minutes after dosing

Outcome Measure Data

Analysis Population Description

Only the patients who received IV glucose administration are included.

Arm/Group Title	Dasiglucagon 0.6 mg	Placebo
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue	single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon
Measure Participants	1	1
Number [minutes]	10	14

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Dasiglucagon 0.6 mg		Placebo
Arm/Group Description	single fixed dose (subcutaneous injection) of dasiglucagon Dasiglucagon: Glucagon analogue		single fixed dose (subcutaneous injection) of placebo Placebo: Placebo for dasiglucagon
All Cause Mortality
	Dasiglucagon 0.6 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/10 (0%)
Serious Adverse Events
	Dasiglucagon 0.6 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Dasiglucagon 0.6 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/34 (70.6%)		3/10 (30%)
Gastrointestinal disorders
Nausea	21/34 (61.8%)	21	1/10 (10%)	1
Vomiting	10/34 (29.4%)	11	0/10 (0%)	0
Diarrhea	2/34 (5.9%)	2	0/10 (0%)	0
Dyspepsia	0/34 (0%)	0	1/10 (10%)	1
General disorders
Injection site pain	2/34 (5.9%)	2	0/10 (0%)	0
Infusion site extravasation	1/34 (2.9%)	1	0/10 (0%)	0
Injection site erythema	1/34 (2.9%)	1	0/10 (0%)	0
Infections and infestations
Upper respiratory tract infection	0/34 (0%)	0	1/10 (10%)	1
Metabolism and nutrition disorders
Hypoglycemia	6/34 (17.6%)	29	2/10 (20%)	3
Nervous system disorders
Headache	4/34 (11.8%)	4	0/10 (0%)	0
Dizziness	1/34 (2.9%)	1	0/10 (0%)	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/34 (2.9%)	1	0/10 (0%)	0
Skin and subcutaneous tissue disorders
Hyperhidrosis	1/34 (2.9%)	1	0/10 (0%)	0
Vascular disorders
Phlebitis	1/34 (2.9%)	1	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.