CompletedPhase 3Results posted

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

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)

Lead sponsor

Zealand Pharma

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

112

Study population

Prediabetes / glucose intolerance, Type 1 diabetes

Eligibility highlights

•HbA1c ≤10%

Primary endpoint

•ADA

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03216226

Org study IDZP4207-16136

Timeline

Milestones

Study start2017-06-28actual

Study first posted2017-07-13actual

Primary completion2018-02-13actual

Study completion2018-02-13actual

Results first posted2021-02-16actual

Last update posted2021-05-04actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intoleranceType 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (34)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

6 endpoints

Secondary/protocol endpoint

Pharmacodynamics - Change From Baseline Plasma Glucose

Time frame:90 minutes

change from baseline, improvement

Secondary/registry result

Pharmacodynamics - Change From Baseline Plasma Glucose

Time frame:90 minutes

change from baseline, improvement

Posted result

Group	Mean · mmol/L	95% CI
Dasiglucagon (ZP4207)Day 0	6.25	-
Day 14	6.88	-
GlucaGenDay 0	6	-
Day 14	6.21	-

Secondary/protocol endpoint

Pharmacodynamics - Time to Maximum Plasma Glucose Concentration

Time frame:90 minutes

time to event, event

Secondary/registry result

Pharmacodynamics - Time to Maximum Plasma Glucose Concentration

Time frame:90 minutes

time to event, event

Posted result

Group	Median · hours	95% CI
Dasiglucagon (ZP4207)Day 0	1.5	0.0833 - 1.57
Day 14	1.5	0.167 - 1.58
GlucaGenDay 0	1.5	0.483 - 1.6
Day 14	1.5	0.0833 - 1.52

Secondary/protocol endpoint

Pharmacodynamics - An Increase in the Plasma Glucose Concentration of ≥20 mg/dL Within 30 Minutes After Treatment

Time frame:30 minutes

threshold achievement, improvement

Secondary/registry result

Pharmacodynamics - An Increase in the Plasma Glucose Concentration of ≥20 mg/dL Within 30 Minutes After Treatment

Time frame:30 minutes

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Dasiglucagon (ZP4207)Day 0	54	-
Day 0	3	-
Day 14	51	-
Day 14	1	-
GlucaGenDay 0	51	-
Day 0	3	-
Day 14	47	-
Day 14	2	-