Phase 3
Completed N=112
A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus
Hypoglycemia · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03216226 ↗
Enrolled (actual)
112
Serious AEs
0.9%
Results posted
Feb 2021
Primary outcomePrimary: Percentage of Patients With ADA — 0; 0; 56; 54 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With ADA |
0; 0; 56; 54 | — |
| SECONDARY Percentage of Patients With Treatment-induced ADA |
0; 0; 56; 54 | — |
| SECONDARY Percentage of Patients With Treatment-boosted ADA |
0; 0; 56; 54 | — |
| SECONDARY Characterization of ADA Response - Neutralizing Activity |
— | — |
| SECONDARY Characterization of ADA Response - Titer of Neutralizing Activity |
— | — |
| SECONDARY Characterization of ADA Response - Cross-reactivity |
— | — |
| SECONDARY Characterization of ADA Response - Timing |
— | — |
| SECONDARY Characterization of ADA Response - Duration |
— | — |
| SECONDARY Pharmacokinetics - Area Under the Plasma Concentration Curve |
1560; 1290; 1640; 1290 | — |
| SECONDARY Pharmacokinetics - Area Under the Plasma Concentration Curve |
1560; 1290; 1640; 1290 | — |
| SECONDARY Pharmacokinetics - Maximum Plasma Concentration |
1390; 1490; 1820; 1430 | — |
| SECONDARY Pharmacokinetics - Time to Maximum Plasma Concentration |
0.5; 0.483; 0.5; 0.5 | — |
| SECONDARY Pharmacodynamics - Area Under the Effect Curve |
5.9; 5.86; 6.47; 6.04 | — |
| SECONDARY Pharmacodynamics - Area Under the Effect Curve |
5.9; 5.86; 6.47; 6.04 | — |
| SECONDARY Pharmacodynamics - Change From Baseline Plasma Glucose |
6.25; 6; 6.88; 6.21 | — |
| SECONDARY Pharmacodynamics - Time to Maximum Plasma Glucose Concentration |
1.5; 1.5; 1.5; 1.5 | — |
| SECONDARY Pharmacodynamics - An Increase in the Plasma Glucose Concentration of ≥20 mg/dL Within 30 Minutes After Treatment |
54; 51; 3; 3; 51; 47 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03216226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.