Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dasiglucagon 0.6 mg Placebo
Hide 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
Arm/Group Title Dasiglucagon 0.6 mg Placebo Total
Hide 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
Hide 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)
1.Primary Outcome
Title Time to Plasma Glucose Recovery.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Description Area under the drug concentration curve (AUC) from time zero to 90 minutes, AUC0-90min
Time Frame 0-90 minutes after dosing
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Area under the drug concentration curve (AUC) from time zero to 120 minutes, AUC0-120min
Time Frame 0-120 minutes after dosing
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Maximum plasma dasiglucagon concentration (Cmax)
Time Frame 0-120 minutes after dosing
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Time to maximum plasma dasiglucagon concentration (tmax)
Time Frame 0-120 minutes after dosing
Hide Outcome Measure Data
Hide 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
Hide 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
Hide Description Occurrence of antibodies against dasiglucagon. Presented as percentage of patients with antibodies.
Time Frame 58 days
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only the patients who received IV glucose administration are included.
Arm/Group Title Dasiglucagon 0.6 mg Placebo
Hide 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
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dasiglucagon 0.6 mg Placebo
Hide 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%)    
Hide 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%)    
Hide 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
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Dr Kim Mark Knudsen
Organization: Zealand Pharma A/S
Phone: +4550603780
EMail: KMKnudsen@zealandpharma.com
Layout table for additonal information
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