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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03216226
• Date of registration: 07/07/2017
• Prospective Registration: No
• Primary sponsor: Zealand Pharma
• Public title: A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus
• Scientific title: A Phase 3, Randomized, Double-Blind, Parallel Group Safety Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen® Administered Subcutaneously in Patients With Type 1 Diabetes Mellitus (T1DM)
• Date of first enrolment: June 28, 2017
• Target sample size: 112
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03216226
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Austria, Canada, Germany, United States

Contacts

• Name: Dorte Skydsgaard
• Affiliation: Zealand Pharma A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Informed consent obtained before any trial-related activities (trial-related
activities are any procedure that would not have been performed during normal
management of the patient)

- Availability for the entire trial period

- Age between 18 and 70 years, both inclusive

- Male or female patients with T1DM for at least 1 year. Diagnostic criteria as defined
by the American Diabetes Association

- Hemoglobin A1c (HbA1c) <10%

- Stable anti-diabetic treatment for at least 1 month (e.g. within 10% insulin dose
adjustment)

Exclusion Criteria:

- Previous administration of dasiglucagon (previously referred to as ZP4207)

- Known or suspected allergy to trial medication(s) or related products

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

- Previous participation (randomization) in this trial

- Females who are pregnant according to a positive pregnancy test, actively attempting
to get pregnant, or are lactating

- Patients on a closed loop artificial pancreas

- Receipt of any investigational drug within 3 months prior to screening

- Active malignancy within the last 5 years

- Congestive heart failure, New York Heart Association class II-IV

- Inadequately treated blood pressure as defined as systolic blood pressure =160 mmHg or
diastolic blood pressure =90 mmHg at screening

- Current bleeding disorder, including use of anticoagulant treatment

- Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma
(i.e. insulin-secreting pancreas tumor)

- Known or suspected HIV infection

- Use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs
in the previous 28 days before Day 1 of this trial

- Use of systemic corticosteroids, anti-inflammatory biological agents, kinase
inhibitors or other immune modulating agents within the last 3 months prior to
screening

- Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks
prior to screening

- A positive result in the alcohol and/or urine drug screen at the screening visit.
Significant history of alcoholism or drug abuse as judged by the investigator or
consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day
for women.

- Surgery or trauma with significant blood loss within the last 2 months prior to
screening

- Use of prescription or non-prescription medications known to cause QT prolongation



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypoglycemia

Diabetes Mellitus, Type 1

Intervention(s)

Drug: dasiglucagon

Drug: GlucaGen

Primary Outcome(s)

Overall ADA incidence [Time Frame: 104 days]

Secondary Outcome(s)

Characterization of ADA response - incidence of neutralizing activity [Time Frame: 104 days]

Pharmacodynamics - Area under the effect curve [Time Frame: 0-30 minutes]

Characterization of ADA response - titer of neutralizing activity [Time Frame: 104 days]

Safety - Laboratory parameters [Time Frame: 104 days]

Treatment-induced ADA [Time Frame: 104 days]

Safety - Electrocardiogram [Time Frame: 104 days]

Characterization of ADA response - cross-reactivity [Time Frame: 104 days]

Characterization of ADA response - duration [Time Frame: 104 days]

Characterization of ADA response - timing [Time Frame: 104 days]

Pharmacodynamics - Area under the effect curve [Time Frame: 0-90 minutes]

Pharmacodynamics - Change from baseline plasma glucose [Time Frame: 90 minutes]

Pharmacodynamics - Time to maximum plasma glucose concentration [Time Frame: 90 minutes]

Treatment-boosted ADA [Time Frame: 104 days]

Safety - Adverse Events [Time Frame: 104 days]

Safety - Physical Examination [Time Frame: 104 days]

Pharmacokinetics - Area under the plasma concentration curve [Time Frame: 0-90 minutes]

Pharmacokinetics - Maximum plasma concentration [Time Frame: 90 minutes]

Pharmacokinetics - Area under the plasma concentration curve [Time Frame: 0-30 minutes]

Pharmacokinetics - Time to maximum plasma concentration [Time Frame: 90 minutes]

Safety - Vital Signs [Time Frame: 104 days]

Secondary ID(s)

ZP4207-16136

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

SynteractHCR