Clinical trial

A Phase 3, Single-administration, Open-label Trial to Assess the Efficacy, Safety, PK, and PD of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Below 6 Years of Age With Type 1 Diabetes

Name

ZP4207-21052

Description

This research study will investigate whether dasiglucagon as a rescue therapy for participants between 1 and 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics). Participants will receive 1 single dose as an injection under the skin (subcutaneous, s.c.). Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.

Trial arms

Trial start

2023-05-09

Estimated PCD

2024-03-25

Trial end

2024-09-25

Status

Recruiting

Phase

Early phase I

Treatment

Dasiglucagon

Dasiglucagon, 0.6 mg/0.6 mL will be administered as an under the skin (subcutaneous, s.c.) injection by a prefilled syringe, into the abdominal region.

Arms:

Dasiglucagon 0.6 mg

Other names:

Zegalogue, ZP4207

Size

Primary endpoint

Plasma glucose change from baseline at 30 minutes after IMP injection or at the time of rescue by intravenous (IV) glucose

Measured pre-dose (baseline) and 30 minutes after dosing on Day 1

Eligibility criteria

Inclusion Criteria: * Participants who are confirmed as having T1D based on medical history and are receiving daily insulin therapy via insulin pump * Body weight greater than 8 kg * Further inclusion criteria apply Exclusion Criteria: * Known or suspected allergy to the IMP or related products * Any condition that in the investigators opinion may result in diminished hepatic glycogen stores (eg prolonged fasting (more than 24 hours) at Visit 2 * History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema) * History of hypoglycemia unawareness * History of hypoglycemic events associated with seizures * Further exclusion criteria apply

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ESTIMATED'}}

Updated at

2023-08-31

1 organization

1 product

1 indication

Product

Dasiglucagon

Indication

Hypoglycemia

Organization

Zealand Pharma