Trial Outcomes & Findings for A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus (NCT NCT03216226)

NCT ID: NCT03216226

Last Updated: 2021-05-04

Results Overview

Percentage of the combined results of treatment-induced ADA-positive patients and treatment-boosted ADA-positive patients out of the total number of evaluable patients. ADA = antidrug antibodies.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 112 participants
• Primary outcome timeframe: 104 days after the first dose
• Results posted on: 2021-05-04

Participant Flow

Participant milestones

Measure	Dasiglucagon (ZP4207) 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Overall Study STARTED	57	55
Overall Study Randomized and Treated	57	54
Overall Study COMPLETED	52	50
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Dasiglucagon (ZP4207) 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Overall Study Adverse Event	3	0
Overall Study Protocol Violation	1	3
Overall Study Patient unable to take time off work to come in for the third injection	1	0
Overall Study Deviation from protocol window during visit as patient had to leave for work	0	1
Overall Study Patient withdrawn prior to treatment. Patient veins unsuitable for blood draws	0	1

Baseline Characteristics

A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Dasiglucagon (ZP4207) n=57 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=5 Participants	52 Participants n=7 Participants	107 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	45.3 years STANDARD_DEVIATION 12.21 • n=5 Participants	38.8 years STANDARD_DEVIATION 13.65 • n=7 Participants	42.1 years STANDARD_DEVIATION 13.29 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	32 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	52 Participants n=7 Participants	102 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment Austria	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Germany	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Body weight	82.9 kg STANDARD_DEVIATION 18.44 • n=5 Participants	82.7 kg STANDARD_DEVIATION 16.25 • n=7 Participants	82.8 kg STANDARD_DEVIATION 17.33 • n=5 Participants
Body mass index	27.2 kg/m^2 STANDARD_DEVIATION 4.88 • n=5 Participants	27.4 kg/m^2 STANDARD_DEVIATION 4.70 • n=7 Participants	27.3 kg/m^2 STANDARD_DEVIATION 4.77 • n=5 Participants

PRIMARY outcome

Timeframe: 104 days after the first dose

Population: Full analysis set of all patients in the safety analysis set (those randomized who received at least 1 dose of trial product) with at least 1 measurement of ADA titres at baseline

Percentage of the combined results of treatment-induced ADA-positive patients and treatment-boosted ADA-positive patients out of the total number of evaluable patients. ADA = antidrug antibodies.

Outcome measures

Measure	Dasiglucagon (ZP4207) n=56 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Percentage of Patients With ADA Patients with ADA	0 Participants	0 Participants
Percentage of Patients With ADA Patients without ADA	56 Participants	54 Participants

SECONDARY outcome

Timeframe: 104 days after the first dose

Population: Full analysis set of all patients in the safety analysis set (those randomized who received at least 1 dose of trial product) with at least 1 measurement of ADA titres at baseline

Percentage of the total number of evaluable patients that were ADA negative at baseline and ADA positive after drug administration out of the total number of evaluable patients. ADA = antidrug antibodies

Outcome measures

Measure	Dasiglucagon (ZP4207) n=56 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Percentage of Patients With Treatment-induced ADA Patients with ADA	0 Participants	0 Participants
Percentage of Patients With Treatment-induced ADA Patients without ADA	56 Participants	54 Participants

SECONDARY outcome

Timeframe: 104 days after the first dose

Population: Full analysis set of all patients in the safety analysis set (those randomized who received at least 1 dose of trial product) with at least 1 measurement of ADA titres at baseline

Percentage of baseline ADA-positive patients with significant increases (≥5-fold) in ADA titre after drug administration out of the total number of evaluable patients. ADA = antidrug antibodies

Outcome measures

Measure	Dasiglucagon (ZP4207) n=56 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Percentage of Patients With Treatment-boosted ADA Patients with ADA	0 Participants	0 Participants
Percentage of Patients With Treatment-boosted ADA Patients without ADA	56 Participants	54 Participants

SECONDARY outcome

Timeframe: 104 days after the first dose

Population: No ADAs were recorded in this trial, therefore it was not possible to characterize the ADA response.

Percentage of ADA positive patients with ADA neutralizing activity. ADA = antidrug antibodies.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 104 days after the first dose

Population: No ADAs were recorded in this trial, therefore it was not possible to characterize the ADA response in terms of titre of neutralizing activity.

Titre of neutralizing activity of ADA positive patients. ADA = antidrug antibodies.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 104 days after the first dose

Population: No ADAs were recorded in this trial, therefore it was not possible to characterize the ADA response in terms of cross-reactivity towards endogenous glucagon.

Percentage of ADA positive patients with cross-reactivity towards endogenous glucagon. ADA = antidrug antibodies.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 104 days after the first dose

Population: No ADAs were recorded in this trial, therefore it was not possible to characterize the ADA response in terms of timing.

The timing of detected ADA response. ADA = antidrug antibodies.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 104 days after the first dose

Population: No ADAs were recorded in this trial, therefore it was not possible to characterize the ADA response in terms of duration.

The Duration of detected ADA response. ADA = antidrug antibodies.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-30 minutes

Population: PK/PD set: all patients in the safety analysis set (patients who were randomized and received at least 1 dose of trial product) with at least 1 pre- and post-dose PK value at 1 visit. PK = pharmacokinetic. PD = pharmacodynamic.

Area under the plasma concentration curve (AUC) 0-30 minutes at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10 and 30 minutes after dosing.

Outcome measures

Measure	Dasiglucagon (ZP4207) n=57 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Pharmacokinetics - Area Under the Plasma Concentration Curve Day 0	425 h*pmol/L Standard Deviation 220	548 h*pmol/L Standard Deviation 226
Pharmacokinetics - Area Under the Plasma Concentration Curve Day 14	499 h*pmol/L Standard Deviation 371	546 h*pmol/L Standard Deviation 181

SECONDARY outcome

Timeframe: 0-90 minutes

Population: PK/PD set: all patients in the safety analysis set (patients who were randomized and received at least 1 dose of trial product) with at least 1 pre- and post-dose PK value at 1 visit. PK = pharmacokinetic. PD = pharmacodynamic.

Area under the plasma concentration curve (AUC) 0-90 minutes at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.

Outcome measures

Measure	Dasiglucagon (ZP4207) n=57 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Pharmacokinetics - Area Under the Plasma Concentration Curve Day 0	1560 h*pmol/L Standard Deviation 615	1290 h*pmol/L Standard Deviation 434
Pharmacokinetics - Area Under the Plasma Concentration Curve Day 14	1640 h*pmol/L Standard Deviation 611	1290 h*pmol/L Standard Deviation 379

SECONDARY outcome

Timeframe: 90 minutes

Population: PK/PD set: all patients in the safety analysis set (patients who were randomized and received at least 1 dose of trial product) with at least 1 pre- and post-dose PK value at 1 visit. PK = pharmacokinetic. PD = pharmacodynamic.

Maximum plasma concentration (Cmax) at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.

Outcome measures

Measure	Dasiglucagon (ZP4207) n=57 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Pharmacokinetics - Maximum Plasma Concentration Day 0	1390 pmol/L Standard Deviation 609	1490 pmol/L Standard Deviation 537
Pharmacokinetics - Maximum Plasma Concentration Day 14	1820 pmol/L Standard Deviation 2460	1430 pmol/L Standard Deviation 498

SECONDARY outcome

Timeframe: 90 minutes

Population: PK/PD set: all patients in the safety analysis set (patients who were randomized and received at least 1 dose of trial product) with at least 1 pre- and post-dose PK value at 1 visit. PK = pharmacokinetic. PD = pharmacodynamic.

Time to maximum plasma concentration (Tmax) at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.

Outcome measures

Measure	Dasiglucagon (ZP4207) n=57 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Pharmacokinetics - Time to Maximum Plasma Concentration Day 0	0.5 hours Interval 0.167 to 1.5	0.483 hours Interval 0.0833 to 0.55
Pharmacokinetics - Time to Maximum Plasma Concentration Day 14	0.5 hours Interval 0.0833 to 1.5	0.5 hours Interval 0.0833 to 0.517

SECONDARY outcome

Timeframe: 0-30 minutes

Population: PK/PD set: all patients in the safety analysis set (patients who were randomized and received at least 1 dose of trial product) with at least 1 pre- and post-dose PK value at 1 visit. PK = pharmacokinetic. PD = pharmacodynamic.

Plasma glucose profiles, area under the effect curve (AUE) 0-30 minutes at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10 and 30 minutes after dosing.

Outcome measures

Measure	Dasiglucagon (ZP4207) n=57 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Pharmacodynamics - Area Under the Effect Curve Day 0	0.799 h*mmol/L Standard Deviation 0.449	0.886 h*mmol/L Standard Deviation 0.504
Pharmacodynamics - Area Under the Effect Curve Day 14	0.869 h*mmol/L Standard Deviation 0.375	0.895 h*mmol/L Standard Deviation 0.511

SECONDARY outcome

Timeframe: 0-90 minutes

Population: PK/PD set: all patients in the safety analysis set (patients who were randomized and received at least 1 dose of trial product) with at least 1 pre- and post-dose PK value at 1 visit. PK = pharmacokinetic. PD = pharmacodynamic.

Plasma glucose profiles, area under the effect curve (AUE) 0-90 minutes at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.

Outcome measures

Measure	Dasiglucagon (ZP4207) n=57 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Pharmacodynamics - Area Under the Effect Curve Day 0	5.9 h*mmol/L Standard Deviation 2.42	5.86 h*mmol/L Standard Deviation 3.14
Pharmacodynamics - Area Under the Effect Curve Day 14	6.47 h*mmol/L Standard Deviation 2.28	6.04 h*mmol/L Standard Deviation 2.63

SECONDARY outcome

Timeframe: 90 minutes

Population: PK/PD set: all patients in the safety analysis set (patients who were randomized and received at least 1 dose of trial product) with at least 1 pre- and post-dose PK value at 1 visit. PK = pharmacokinetic. PD = pharmacodynamic.

Change from baseline plasma glucose to maximum plasma glucose (CEmax) at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.

Outcome measures

Measure	Dasiglucagon (ZP4207) n=57 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Pharmacodynamics - Change From Baseline Plasma Glucose Day 0	6.25 mmol/L Standard Deviation 2.5	6 mmol/L Standard Deviation 3.01
Pharmacodynamics - Change From Baseline Plasma Glucose Day 14	6.88 mmol/L Standard Deviation 2.43	6.21 mmol/L Standard Deviation 2.65

SECONDARY outcome

Timeframe: 90 minutes

Population: PK/PD set: all patients in the safety analysis set (patients who were randomized and received at least 1 dose of trial product) with at least 1 pre- and post-dose PK value at 1 visit. PK = pharmacokinetic. PD = pharmacodynamic.

Time to maximum plasma glucose concentration (Tmax) at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.

Outcome measures

Measure	Dasiglucagon (ZP4207) n=57 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Pharmacodynamics - Time to Maximum Plasma Glucose Concentration Day 0	1.5 hours Interval 0.0833 to 1.57	1.5 hours Interval 0.483 to 1.6
Pharmacodynamics - Time to Maximum Plasma Glucose Concentration Day 14	1.5 hours Interval 0.167 to 1.58	1.5 hours Interval 0.0833 to 1.52

SECONDARY outcome

Timeframe: 30 minutes

Population: PK/PD set: all patients in the safety analysis set (patients who were randomized and received at least 1 dose of trial product) with at least 1 pre- and post-dose PK value at 1 visit. PK = pharmacokinetic. PD = pharmacodynamic.

An increase in the plasma glucose concentration of ≥20 mg/dL within 30 minutes after treatment at visit 2 and visit 4. Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.

Outcome measures

Measure	Dasiglucagon (ZP4207) n=57 Participants 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 Participants 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Pharmacodynamics - An Increase in the Plasma Glucose Concentration of ≥20 mg/dL Within 30 Minutes After Treatment Day 0 · Yes	54 Participants	51 Participants
Pharmacodynamics - An Increase in the Plasma Glucose Concentration of ≥20 mg/dL Within 30 Minutes After Treatment Day 0 · No	3 Participants	3 Participants
Pharmacodynamics - An Increase in the Plasma Glucose Concentration of ≥20 mg/dL Within 30 Minutes After Treatment Day 14 · Yes	51 Participants	47 Participants
Pharmacodynamics - An Increase in the Plasma Glucose Concentration of ≥20 mg/dL Within 30 Minutes After Treatment Day 14 · No	1 Participants	2 Participants

Adverse Events

Dasiglucagon (ZP4207)

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

GlucaGen

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dasiglucagon (ZP4207) n=57 participants at risk 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 participants at risk 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Metabolism and nutrition disorders Hypoglycemia	1.8% 1/57 • Number of events 1 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	0.00% 0/54 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.

Other adverse events

Measure	Dasiglucagon (ZP4207) n=57 participants at risk 3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog	GlucaGen n=54 participants at risk 3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon
Metabolism and nutrition disorders Hypoglycemia	47.4% 27/57 • Number of events 580 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	53.7% 29/54 • Number of events 447 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Metabolism and nutrition disorders Hyperglycemia	5.3% 3/57 • Number of events 3 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	3.7% 2/54 • Number of events 8 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Gastrointestinal disorders Nausea	45.6% 26/57 • Number of events 43 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	42.6% 23/54 • Number of events 33 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Gastrointestinal disorders Vomiting	21.1% 12/57 • Number of events 18 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	14.8% 8/54 • Number of events 9 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Gastrointestinal disorders Diarrhea	7.0% 4/57 • Number of events 4 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	3.7% 2/54 • Number of events 2 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Infections and infestations Viral upper respiratory tract infection	10.5% 6/57 • Number of events 7 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	14.8% 8/54 • Number of events 9 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Infections and infestations Upper respiratory tract infection	3.5% 2/57 • Number of events 2 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	7.4% 4/54 • Number of events 4 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Nervous system disorders Headache	14.0% 8/57 • Number of events 14 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	5.6% 3/54 • Number of events 4 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Nervous system disorders Dizziness	3.5% 2/57 • Number of events 2 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	5.6% 3/54 • Number of events 3 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
General disorders Fatigue	1.8% 1/57 • Number of events 1 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	1.9% 1/54 • Number of events 1 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
General disorders Injection site erythema	0.00% 0/57 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	3.7% 2/54 • Number of events 3 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Vascular disorders Hypotension	3.5% 2/57 • Number of events 2 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	3.7% 2/54 • Number of events 3 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Vascular disorders Hypertension	1.8% 1/57 • Number of events 1 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	3.7% 2/54 • Number of events 3 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/57 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	3.7% 2/54 • Number of events 2 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Blood and lymphatic system disorders Leukocytosis	3.5% 2/57 • Number of events 2 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	7.4% 4/54 • Number of events 5 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/57 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	5.6% 3/54 • Number of events 4 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.
Eye disorders Retinopathy	0.00% 0/57 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.	3.7% 2/54 • Number of events 2 • 104 days Adverse events were recorded at each trial visit by the investigator or other designated trial personnel.

Additional Information

Kim Mark Knudsen

Zealand Pharma A/S

Phone: +45 50603780

Email: KMKnudsen@zealandpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place