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

Completed · Phase 3

Conditions studied: Hypoglycemia, Diabetes Mellitus, Type 1

In brief

The trial's objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon\* and GlucaGen following subcutaneous (SC) administration in patients with type 1 diabetes mellitus (T1DM) and further to evaluate the safety and tolerability of dasiglucagon and GlucaGen. \*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207

Key facts

Study ID

NCT03216226

Run by

Zealand Pharma

People needed

112

Starts

2017-06-28

Expected to finish

2018-02-13

Last updated by the study team

2021-05-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Compass Research — Orlando, Florida, United States
• Advanced Clinical Research — Meridian, Idaho, United States
• CRC - Clinical Research Center, Medizinische Universität Graz — Graz, Austria
• LMC Manna Research — Barrie, Canada
• LMC Calgary — Calgary, Canada
• LMC Diabetes & Manna Research — Toronto, Canada
• Diabeteszentrum Hamburg West, Gemeinschaftspraxis für Innere Medizin — Hamburg, Germany

Full record on ClinicalTrials.gov

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