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 |
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
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
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