Primary outcomeCount of participants· 104 days after the first dose
Percentage of Patients With ADA
| Group | Value (Participants) |
|---|---|
| Dasiglucagon (ZP4207) | 0 |
| GlucaGen | 0 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus
NCTNCT03216226 (opens ClinicalTrials.gov in a new tab)Other idZP4207-16136
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 112 participants (actual)
- Sponsor
- Zealand Pharma · Industry
- Design
- Randomized · Quadruple masking
- Countries
4 countries
United States, Austria, Canada, Germany
- Start
- 28 Jun 2017
- Primary completion
- 13 Feb 2018
- Completion
- 13 Feb 2018
- First posted
- 13 Jul 2017
- Last update posted
- 4 May 2021
- Conditions
- Hypoglycemia · Diabetes Mellitus, Type 1
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201720182019
- Ph 3
A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus
NCT0321622628 Jun 2017 to 13 Feb 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Interventions
- dasiglucagonDrug
- GlucaGenDrug
Arms2
Experimental
dasiglucagon (ZP4207)
Repeated single fixed doses (s.c.injection) of dasiglucagon
Experimental
GlucaGen
Repeated single fixed doses (s.c.injection) of GlucaGen
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage of Patients With ADA
Time frame · 104 days after the first dose
Registry description
Percentage of the combined results of treatment-induced ADA-positive patients and treatment-boosted ADA-positive patients out of the total number of evaluable patients. ADA = antidrug antibodies.
Secondary outcomes(16)
Percentage of Patients With Treatment-induced ADA
Time frame · 104 days after the first dose
Registry description
Percentage of the total number of evaluable patients that were ADA negative at baseline and ADA positive after drug administration out of the total number of evaluable patients. ADA = antidrug antibodies
Percentage of Patients With Treatment-boosted ADA
Time frame · 104 days after the first dose
Registry description
Percentage of baseline ADA-positive patients with significant increases (≥5-fold) in ADA titre after drug administration out of the total number of evaluable patients. ADA = antidrug antibodies
Characterization of ADA Response - Neutralizing Activity
Time frame · 104 days after the first dose
Registry description
Percentage of ADA positive patients with ADA neutralizing activity. ADA = antidrug antibodies.
Characterization of ADA Response - Titer of Neutralizing Activity
Time frame · 104 days after the first dose
Registry description
Titre of neutralizing activity of ADA positive patients. ADA = antidrug antibodies.
Characterization of ADA Response - Cross-reactivity
Time frame · 104 days after the first dose
Registry description
Percentage of ADA positive patients with cross-reactivity towards endogenous glucagon. ADA = antidrug antibodies.
Characterization of ADA Response - Timing
Time frame · 104 days after the first dose
Registry description
The timing of detected ADA response. ADA = antidrug antibodies.
Characterization of ADA Response - Duration
Time frame · 104 days after the first dose
Registry description
The Duration of detected ADA response. ADA = antidrug antibodies.
Pharmacokinetics - Area Under the Plasma Concentration Curve
Time frame · 0-30 minutes
Registry description
Area under the plasma concentration curve (AUC) 0-30 minutes at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10 and 30 minutes after dosing.
Pharmacokinetics - Area Under the Plasma Concentration Curve
Time frame · 0-90 minutes
Registry description
Area under the plasma concentration curve (AUC) 0-90 minutes at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.
Pharmacokinetics - Maximum Plasma Concentration
Time frame · 90 minutes
Registry description
Maximum plasma concentration (Cmax) at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.
Pharmacokinetics - Time to Maximum Plasma Concentration
Time frame · 90 minutes
Registry description
Time to maximum plasma concentration (Tmax) at visit 2 and 4 (days 0 and 14). Plasma PK concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.
Pharmacodynamics - Area Under the Effect Curve
Time frame · 0-30 minutes
Registry description
Plasma glucose profiles, area under the effect curve (AUE) 0-30 minutes at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10 and 30 minutes after dosing.
Pharmacodynamics - Area Under the Effect Curve
Time frame · 0-90 minutes
Registry description
Plasma glucose profiles, area under the effect curve (AUE) 0-90 minutes at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.
Pharmacodynamics - Change From Baseline Plasma Glucose
Time frame · 90 minutes
Registry description
Change from baseline plasma glucose to maximum plasma glucose (CEmax) at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.
Pharmacodynamics - Time to Maximum Plasma Glucose Concentration
Time frame · 90 minutes
Registry description
Time to maximum plasma glucose concentration (Tmax) at visit 2 and 4 (days 0 and 14). Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.
Pharmacodynamics - An Increase in the Plasma Glucose Concentration of ≥20 mg/dL Within 30 Minutes After Treatment
Time frame · 30 minutes
Registry description
An increase in the plasma glucose concentration of ≥20 mg/dL within 30 minutes after treatment at visit 2 and visit 4. Plasma glucose concentrations were measured before dosing and at 5, 10, 30, 60 and 90 minutes after dosing.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeCount of participants· 104 days after the first dose
Percentage of Patients With Treatment-induced ADA
| Group | Value (Participants) |
|---|---|
| Dasiglucagon (ZP4207) | 0 |
| GlucaGen | 0 |
Secondary outcomeCount of participants· 104 days after the first dose
Percentage of Patients With Treatment-boosted ADA
| Group | Value (Participants) |
|---|---|
| Dasiglucagon (ZP4207) | 0 |
| GlucaGen | 0 |
Secondary outcome· 104 days after the first dose
Characterization of ADA Response - Neutralizing Activity
| Group | Value |
|---|---|
| Dasiglucagon (ZP4207) | not posted |
| GlucaGen | not posted |
Secondary outcome· 104 days after the first dose
Characterization of ADA Response - Titer of Neutralizing Activity
| Group | Value |
|---|---|
| Dasiglucagon (ZP4207) | not posted |
| GlucaGen | not posted |
Secondary outcome· 104 days after the first dose
Characterization of ADA Response - Cross-reactivity
| Group | Value |
|---|---|
| Dasiglucagon (ZP4207) | not posted |
| GlucaGen | not posted |
Secondary outcome· 104 days after the first dose
Characterization of ADA Response - Timing
| Group | Value |
|---|---|
| Dasiglucagon (ZP4207) | not posted |
| GlucaGen | not posted |
Secondary outcome· 104 days after the first dose
Characterization of ADA Response - Duration
| Group | Value |
|---|---|
| Dasiglucagon (ZP4207) | not posted |
| GlucaGen | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Dasiglucagon (ZP4207)3 repeated doses (s.c.injection) of 0.6 mg dasiglucagon, with 1 week between each dose. dasiglucagon: Glucagon Analog | 0 / 57 | 1 / 57 | 42 / 57 |
| GlucaGen3 repeated doses (s.c.injection) of 1.0 mg GlucaGen, with 1 week between each dose. GlucaGen: Native Glucagon | 0 / 54 | 0 / 54 | 43 / 54 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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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