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

• ClinicalTrials.gov Identifier: NCT03688711
• Recruitment Status: Completed
• First Posted: September 28, 2018
• Results First Posted: May 19, 2021
• Last Update Posted: May 19, 2021
• Sponsor: Zealand Pharma
• Information provided by (Responsible Party): Zealand Pharma

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Hypoglycemia; Diabetes Mellitus, Type 1
• Interventions: Drug: Dasiglucagon; Drug: Placebo
• Enrollment: 45

Participant Flow

Recruitment Details
Pre-assignment Details

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 [1]	34	11
Completed	34	10
Not Completed	0	1
Reason Not Completed
Withdrawal by Subject	0	1
[1] Randomized

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 Number of Baseline Participants		34	10	44
Baseline Analysis Population Description		The safety population of all randomized subjects who received at least one dose of trial drug
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	34 participants	10 participants	44 participants
		42.4 (13.49)	36.5 (12.80)	41.0 (13.42)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	10 participants	44 participants
	Female	18 52.9%	1 10.0%	19 43.2%
	Male	16 47.1%	9 90.0%	25 56.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	10 participants	44 participants
	Hispanic or Latino	4 11.8%	3 30.0%	7 15.9%
	Not Hispanic or Latino	30 88.2%	7 70.0%	37 84.1%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	10 participants	44 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	1 10.0%	1 2.3%
	Black or African American	0 0.0%	1 10.0%	1 2.3%
	White	34 100.0%	7 70.0%	41 93.2%
	More than one race	0 0.0%	1 10.0%	1 2.3%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	34 participants	10 participants	44 participants
		34 100.0%	10 100.0%	44 100.0%
Body weight; Mean (Standard Deviation); Unit of measure: Kg
	Number Analyzed	34 participants	10 participants	44 participants
		84.49 (20.102)	83.69 (10.812)	84.30 (18.295)
Body mass index; Mean (Standard Deviation); Unit of measure: Kg per square metre
	Number Analyzed	34 participants	10 participants	44 participants
		28.41 (5.802)	27.92 (3.975)	28.30 (5.402)
Duration of diabetes; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	34 participants	10 participants	44 participants
		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
Overall Number of Participants Analyzed	34	10
Median (95% Confidence Interval); Unit of Measure: minutes
	10.0; (8.0 to 12.0)	35.0 [1]; (20.0 to NA)

[1]

The upper limit was not estimable due to insufficient number of participants reaching recovery

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

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
Overall Number of Participants Analyzed	34	10
Measure Type: Count of Participants; Unit of Measure: Participants
Glucose recovery within 30 minutes	33 97.1%	5 50.0%
Glucose recovery within 20 minutes	32 94.1%	1 10.0%
Glucose recovery within 15 minutes	30 88.2%	0 0.0%
Glucose recovery within 10 minutes	21 61.8%	0 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	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0012
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0006
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

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
Overall Number of Participants Analyzed	34	10
Mean (Standard Deviation); Unit of Measure: mg/dL
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	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

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
Overall Number of Participants Analyzed	34	10
Median (95% Confidence Interval); Unit of Measure: minutes
	9.0; (8.0 to 10.0)	27.5; (12.0 to 40.0)

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

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
Overall Number of Participants Analyzed	34	10
Mean (Standard Deviation); Unit of Measure: 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	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.05
	Confidence Interval	(2-Sided) 95%; 2.71 to 6.05
	Estimation Comments	[Not Specified]

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
Overall Number of Participants Analyzed	34
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: 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
Overall Number of Participants Analyzed	34
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: 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
Overall Number of Participants Analyzed	34
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: 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
Overall Number of Participants Analyzed	34
Median (Full Range); Unit of Measure: minutes
	35; (15 to 60)

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
Overall Number of Participants Analyzed	34	10
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	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
Overall Number of Participants Analyzed	34	10
Measure Type: Count of Participants; Unit of Measure: Participants
	1 2.9%	1 10.0%

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
Overall Number of Participants Analyzed	1	1
Measure Type: Number; Unit of Measure: minutes
	10	14

Adverse Events

Time Frame	8 weeks
Adverse Event Reporting Description	[Not Specified]
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 (%)		Affected / at Risk (%)
Total	0/34 (0.00%)		0/10 (0.00%)
Serious Adverse Events
	Dasiglucagon 0.6 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0.00%)		0/10 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Dasiglucagon 0.6 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/34 (70.59%)		3/10 (30.00%)
Gastrointestinal disorders
Nausea † 1	21/34 (61.76%)	21	1/10 (10.00%)	1
Vomiting † 1	10/34 (29.41%)	11	0/10 (0.00%)	0
Diarrhea † 1	2/34 (5.88%)	2	0/10 (0.00%)	0
Dyspepsia † 1	0/34 (0.00%)	0	1/10 (10.00%)	1
General disorders
Injection site pain † 1	2/34 (5.88%)	2	0/10 (0.00%)	0
Infusion site extravasation † 1	1/34 (2.94%)	1	0/10 (0.00%)	0
Injection site erythema † 1	1/34 (2.94%)	1	0/10 (0.00%)	0
Infections and infestations
Upper respiratory tract infection † 1	0/34 (0.00%)	0	1/10 (10.00%)	1
Metabolism and nutrition disorders
Hypoglycemia † 1	6/34 (17.65%)	29	2/10 (20.00%)	3
Nervous system disorders
Headache † 1	4/34 (11.76%)	4	0/10 (0.00%)	0
Dizziness † 1	1/34 (2.94%)	1	0/10 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain † 1	1/34 (2.94%)	1	0/10 (0.00%)	0
Skin and subcutaneous tissue disorders
Hyperhidrosis † 1	1/34 (2.94%)	1	0/10 (0.00%)	0
Vascular disorders
Phlebitis † 1	1/34 (2.94%)	1	0/10 (0.00%)	0
1 Term from vocabulary, MedDRA 22.0; † Indicates events were collected by systematic assessment

Limitations and 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.

Results Point of Contact

• Name/Title: Dr Kim Mark Knudsen
• Organization: Zealand Pharma A/S
• Phone: +4550603780
• EMail: KMKnudsen@zealandpharma.com

• Responsible Party: Zealand Pharma
• ClinicalTrials.gov Identifier: NCT03688711
• Other Study ID Numbers: ZP4207-17145
• First Submitted: September 25, 2018
• First Posted: September 28, 2018
• Results First Submitted: March 26, 2021
• Results First Posted: May 19, 2021
• Last Update Posted: May 19, 2021