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

NCT03216226 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ZP4207-16136
• Study Type: interventional
• Target: 112
• Locations: 4 countries
• Sites: 7

Brief 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

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Keywords

Glucagon; Dasiglucagon

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With ADA

  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.

  104 days after the first dose

Secondary Outcomes (16)

• Percentage of Patients With Treatment-induced ADA

  104 days after the first dose

• Percentage of Patients With Treatment-boosted ADA

  104 days after the first dose

• Characterization of ADA Response - Neutralizing Activity

  104 days after the first dose

• Characterization of ADA Response - Titer of Neutralizing Activity

  104 days after the first dose

• Characterization of ADA Response - Cross-reactivity

  104 days after the first dose

Study Arms (2)

dasiglucagon (ZP4207)

EXPERIMENTAL

Repeated single fixed doses (s.c.injection) of dasiglucagon

Drug: dasiglucagon

GlucaGen

EXPERIMENTAL

Repeated single fixed doses (s.c.injection) of GlucaGen

Drug: GlucaGen

Interventions

dasiglucagon DRUG

Glucagon Analog

Also known as: ZP4207

dasiglucagon (ZP4207)

GlucaGen DRUG

Native Glucagon

Also known as: GlucaGen HypoKit

GlucaGen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Zealand Pharma: lead
• SynteractHCR: collaborator

Study Sites (7)

Compass Research

Orlando, Florida, 32806, United States

Location

Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

CRC - Clinical Research Center, Medizinische Universität Graz

Graz, Austria

Location

LMC Manna Research

Barrie, Canada

Location

LMC Calgary

Calgary, Canada

Location

LMC Diabetes & Manna Research

Toronto, Canada

Location

Diabeteszentrum Hamburg West, Gemeinschaftspraxis für Innere Medizin

Hamburg, Germany

Location

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Interventions

dasiglucagon; Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Kim Mark Knudsen
• Organization: Zealand Pharma A/S

KMKnudsen@zealandpharma.com

+45 50603780

Study Officials

• Christina Sylvest, MSc Pharm

  Zealand Pharma A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 13, 2017
• Study Start: June 28, 2017
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: May 4, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-04

Locations

US (2); AU (1); DE (1); CA (3)