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



Status:Completed
Conditions:Endocrine, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:4/4/2019
Start Date:June 28, 2017
End Date:February 14, 2018

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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)

The trial's objective is to evaluate the immunogenicity of repeated single doses of
dasiglucagon* and GlucaGen following subcutaneous (s.c.) administration in T1DM patients and
further to evaluate the safety and tolerability of dasiglucagon and GlucaGen.

*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207


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
We found this trial at
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Orlando, FL
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Meridian, Idaho 83642
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Meridian, ID
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