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

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ClinicalTrials.gov Identifier: NCT03378635
Recruitment Status : Completed
First Posted : December 20, 2017
Results First Posted : May 10, 2021
Last Update Posted : June 10, 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: GlucaGen
Drug: Placebo
Enrollment 170
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of placebo

Placebo: Placebo for dasiglucagon

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Period Title: Overall Study
Started [1] 84 43 43
Randomized and Exposed to Treatment 82 43 43
Completed 82 43 43
Not Completed 2 0 0
Reason Not Completed
Adverse Event             1             0             0
Withdrawal by Subject             1             0             0
[1]
Started is defined as randomized
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg Total
Hide Arm/Group Description

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of placebo

Placebo: Placebo for dasiglucagon

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Total of all reporting groups
Overall Number of Baseline Participants 82 43 43 168
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 43 participants 43 participants 168 participants
39.2  (12.1) 38.0  (13.1) 40.2  (11.5) 39.1  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 43 participants 43 participants 168 participants
Female
32
  39.0%
16
  37.2%
15
  34.9%
63
  37.5%
Male
50
  61.0%
27
  62.8%
28
  65.1%
105
  62.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 43 participants 43 participants 168 participants
Hispanic or Latino
2
   2.4%
2
   4.7%
3
   7.0%
7
   4.2%
Not Hispanic or Latino
80
  97.6%
41
  95.3%
40
  93.0%
161
  95.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 43 participants 43 participants 168 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   3.7%
2
   4.7%
0
   0.0%
5
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   2.3%
1
   0.6%
Black or African American
1
   1.2%
1
   2.3%
2
   4.7%
4
   2.4%
White
76
  92.7%
39
  90.7%
39
  90.7%
154
  91.7%
More than one race
1
   1.2%
0
   0.0%
1
   2.3%
2
   1.2%
Unknown or Not Reported
1
   1.2%
1
   2.3%
0
   0.0%
2
   1.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 43 participants 43 participants 168 participants
Canada 18 10 10 38
Austria 33 0 0 33
United States 12 6 6 24
Germany 19 27 27 73
1.Primary Outcome
Title Time to Plasma Glucose Recovery
Hide Description 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.
Time Frame 0-45 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of all randomized patients who received at least one dose of trial product
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of placebo

Placebo: Placebo for dasiglucagon

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 82 43 43
Median (95% Confidence Interval)
Unit of Measure: minutes
10
(10 to 10)
40
(30 to 40)
12
(10 to 12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dasiglucagon 0.6 mg, Placebo
Comments The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test. Kaplan-Meier estimate with 95% CI, p-value based on treatment group difference between dasiglucagon and placebo using a two-sided log-rank test stratified by injection site. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Plasma Glucose Recovery
Hide Description 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.
Time Frame 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of all randomized patients who received at least one dose of trial product
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of placebo

Placebo: Placebo for dasiglucagon

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 82 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
Glucose recovery at 30 minutes
82
 100.0%
20
  46.5%
43
 100.0%
Glucose recovery at 20 minutes
81
  98.8%
6
  14.0%
42
  97.7%
Glucose recovery at 15 minutes
81
  98.8%
1
   2.3%
41
  95.3%
Glucose recovery at 10 minutes
53
  64.6%
0
   0.0%
21
  48.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dasiglucagon 0.6 mg, Placebo
Comments Pairwise test of independent binomial proportions with Fisher's Exact test comparing dasiglucagon versus placebo. 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 <0.001
Comments p-value was <0.001 at all time points (10, 15, 20 and 30 minutes)
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, 20 minutes, 15 minutes and 10 minutes after study drug injection without administration of rescue intravenous glucose
Time Frame 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of all randomized patients who received at least one dose of trial product
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of placebo

Placebo: Placebo for dasiglucagon

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 82 43 43
Mean (Standard Deviation)
Unit of Measure: mg/dL
At 30 minutes 90.9  (18.2) 19.1  (13.0) 88.5  (19.2)
At 20 minutes 59.7  (15.0) 8.7  (10.8) 58.4  (15.6)
At 15 minutes 43.5  (12.51) 6.65  (6.82) 44.1  (14.0)
At 10 minutes 23.9  (9.84) -0.14  (5.65) 22.0  (10.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dasiglucagon 0.6 mg, Placebo
Comments Plasma glucose (PG) change from baseline at rescue was carried forward in patients who required rescue intravenous (IV) glucose before reaching PG recovery. Change from baseline was analyzed using an ANCOVA, with treatment group as fixed effect and baseline PG as covariate. Group difference was evaluated inferentially following an a priori defined hierarchical test order, proceeding until the first failure to reject the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value was <0.001 at all time points (10, 15, 20 and 30 minutes)
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Time to Target
Hide Description 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.
Time Frame 0-45 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of all randomized patients who received at least one dose of trial product
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of placebo

Placebo: Placebo for dasiglucagon

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 82 43 43
Median (95% Confidence Interval)
Unit of Measure: minutes
8
(8 to 8)
25
(20 to 30)
8
(8 to 10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dasiglucagon 0.6 mg, Placebo
Comments The treatment group difference between dasiglucagon and placebo was evaluated using a Kaplan-Meier estimate with 95% confidence interval, p-value based on a pairwise two-sided log-rank test versus placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
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. Samples were collected pre-dose, and at 4, 6, 8, 10, 12, 15, 17, 20, 25 and 30 minutes after dosing.
Time Frame 0-30 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of all randomized patients who received at least one dose of trial product
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of placebo

Placebo: Placebo for dasiglucagon

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 82 43 43
Mean (Standard Deviation)
Unit of Measure: mg*h/dL
21.0  (5.26) 3.57  (2.86) 20.4  (5.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dasiglucagon 0.6 mg, Placebo
Comments The log-transformed AUC endpoint was analyzed using an analysis of covariance model with treatment as fixed effect and baseline plasma glucose modeled as a covariate. The least squares means treatment group differences were back-transformed (anti-logged) for presentation as a ratio of the treatment group geometric means, with their corresponding 95% confidence interval.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.131
Confidence Interval (2-Sided) 95%
0.1 to 0.171
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Pharmacokinetics - Area Under the Plasma Concentration Curve
Hide Description 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.
Time Frame 0-90 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 82 43
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pmol*h/L
1430
(34.2%)
1300
(27.5%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dasiglucagon 0.6 mg, GlucaGen® 1.0 mg
Comments Least square mean ratio for GlucaGen: dasiglucagon
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.144
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.801 to 1.033
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Pharmacokinetics - Area Under the Plasma Concentration Curve
Hide Description 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.
Time Frame 0-120 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 82 43
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pmol*h/L
1770
(31.2%)
1490
(27.2%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dasiglucagon 0.6 mg, GlucaGen® 1.0 mg
Comments Least square mean ratio for GlucaGen: dasiglucagon
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.844
Confidence Interval (2-Sided) 95%
0.749 to 0.951
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Pharmacokinetics - Maximum Plasma Concentration
Hide Description 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.
Time Frame 0-120 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 82 43
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pmol/L
1280
(37.7%)
1490
(34.5%)
9.Secondary Outcome
Title Pharmacokinetics - Time to Maximum Plasma Concentration
Hide Description 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.
Time Frame 0-120 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 82 43
Median (Full Range)
Unit of Measure: hours
0.670
(0.250 to 1.00)
0.250
(0.230 to 0.670)
10.Secondary Outcome
Title Immunogenicity - Occurence of Anti-drug Antibodies
Hide Description Occurence of antibodies against dasiglucagon/GlucaGen
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set of all randomized patients who received trial medication (which was the same as the full analysis set)
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 82 43
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-drug antibodies at follow-up day 28
1
   1.2%
0
   0.0%
Anti-drug antibodies at second follow up
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Rescue Infusion of IV Glucose During the Hypoglycemic Clamp Procedure
Hide Description Number of patients receiving administration of rescue infusion of IV glucose during the hypoglycemic clamp procedure. IV = intravenous
Time Frame 0-45 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set of all randomized patients who received trial medication (which was the same as the full analysis set)
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of placebo

Placebo: Placebo for dasiglucagon

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 82 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Time to First Rescue Infusion of IV Glucose
Hide Description Time to first rescue administration of rescue infusion of IV glucose. IV = intravenous
Time Frame 0-45 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
No patients received IV glucose infusions therefore there are no data available for this outcome measure
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of placebo

Placebo: Placebo for dasiglucagon

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events (AEs) were collected from the first trial-related activity after the patient had signed the informed consent to the end of the follow-up period, i.e. over 28 days
Adverse Event Reporting Description All AEs, either observed by the investigator or reported by the patient, were recorded by the investigator and evaluated, including diagnosis, if possible. If no diagnosis was made, the investigator was to record each sign and symptom as individual AEs. Information included date and time of onset and resolution, date and time of investigator's first information on the AE, seriousness, severity, casual relationship with investigational product, interruption/withdrawal of treatment and outcome.
 
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description

Single fixed dose (s.c.injection) of dasiglucagon

Dasiglucagon: Glucagon analog

Single fixed dose (s.c.injection) of placebo

Placebo: Placebo for dasiglucagon

Single fixed dose (s.c.injection) of GlucaGen®

GlucaGen: Native glucagon

All-Cause Mortality
Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/82 (0.00%)      0/43 (0.00%)      0/43 (0.00%)    
Hide Serious Adverse Events
Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/82 (0.00%)      0/43 (0.00%)      0/43 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   66/82 (80.49%)      14/43 (32.56%)      32/43 (74.42%)    
Blood and lymphatic system disorders       
Anemia  1  0/82 (0.00%)  0 0/43 (0.00%)  0 1/43 (2.33%)  1
Lymphadenopathy  1  0/82 (0.00%)  0 1/43 (2.33%)  1 0/43 (0.00%)  0
Cardiac disorders       
Bradycardia  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  0/82 (0.00%)  0 0/43 (0.00%)  0 1/43 (2.33%)  1
Eye disorders       
Asthenopia  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Gastrointestinal disorders       
Nausea  1  45/82 (54.88%)  46 1/43 (2.33%)  1 23/43 (53.49%)  24
Vomiting  1  19/82 (23.17%)  25 1/43 (2.33%)  1 9/43 (20.93%)  11
Diarrhea  1  4/82 (4.88%)  4 0/43 (0.00%)  0 1/43 (2.33%)  1
Abdominal tenderness  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Hypoesthesia oral  1  0/82 (0.00%)  0 1/43 (2.33%)  1 0/43 (0.00%)  0
General disorders       
Infusion site rash  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Injection site erythema  1  1/82 (1.22%)  1 2/43 (4.65%)  2 2/43 (4.65%)  2
Injection site edema  1  0/82 (0.00%)  0 0/43 (0.00%)  0 1/43 (2.33%)  1
Injection site pain  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Pyrexia  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Immune system disorders       
Seasonal allergy  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Infections and infestations       
Nasopharyngitis  1  5/82 (6.10%)  5 1/43 (2.33%)  1 0/43 (0.00%)  0
Ear infection  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Gastroenteritis  1  0/82 (0.00%)  0 1/43 (2.33%)  1 0/43 (0.00%)  0
Pharyngitis  1  2/82 (2.44%)  2 0/43 (0.00%)  0 0/43 (0.00%)  0
Sinusitis  1  0/82 (0.00%)  0 1/43 (2.33%)  1 0/43 (0.00%)  0
Metabolism and nutrition disorders       
Hypoglycemia  1  23/82 (28.05%)  39 5/43 (11.63%)  6 9/43 (20.93%)  10
Hyperglycaemia  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Ketosis  1  1/82 (1.22%)  1 0/43 (0.00%)  0 1/43 (2.33%)  1
Vitamin D deficiency  1  0/82 (0.00%)  0 0/43 (0.00%)  0 1/43 (2.33%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/82 (0.00%)  0 1/43 (2.33%)  1 0/43 (0.00%)  0
Back pain  1  2/82 (2.44%)  2 0/43 (0.00%)  0 0/43 (0.00%)  0
Myalgia  1  0/82 (0.00%)  0 0/43 (0.00%)  0 1/43 (2.33%)  1
Pain in extremity  1  1/82 (1.22%)  1 1/43 (2.33%)  1 0/43 (0.00%)  0
Nervous system disorders       
Headache  1  10/82 (12.20%)  10 2/43 (4.65%)  2 5/43 (11.63%)  5
Burning sensation  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Dizziness  1  0/82 (0.00%)  0 0/43 (0.00%)  0 2/43 (4.65%)  2
Presyncope  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Renal and urinary disorders       
Pollakiuria  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Reproductive system and breast disorders       
Dysmenorrhea  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Oropharyngeal pain  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Vascular disorders       
Hot flush  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
Orthostatic hypotension  1  0/82 (0.00%)  0 0/43 (0.00%)  0 1/43 (2.33%)  1
Thrombophlebitis  1  1/82 (1.22%)  1 0/43 (0.00%)  0 0/43 (0.00%)  0
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
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: NCT03378635    
Other Study ID Numbers: ZP4207-16137
First Submitted: December 8, 2017
First Posted: December 20, 2017
Results First Submitted: April 13, 2021
Results First Posted: May 10, 2021
Last Update Posted: June 10, 2021