A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System

NCT05454709 | Withdrawn Phase 2

• 1 other identifier: NL76691.100.22
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to determine the feasibility of dasiglucagon in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. Safety parameters and pharmacodynamics are compared between Dasiglucagon and GlucaGen®. This study is a single-center, double-blinded, randomized, cross over trial in 12 subjects. The subjects will be randomized to receive either dasiglucagon or GlucaGen® for the first three day study period and switch to the alternate treatment after a wash-out treatment.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Time in range

  Time of glucose concentration in the range 3.9-10.0 mmol/L in %

  3 days

Secondary Outcomes (9)

• Side effects

  3 days

• Extra food intakes (food intake diary)

  3 days

• Pharmacodynamics - hypo/hyper

  3 days

• Pharmacodynamics - glucose value

  3 days

• Pharmacodynamics - glycemic variability

  3 days

Study Arms (2)

Dasiglucagon

EXPERIMENTAL

Dasiglucagon 1mg/ml solution for subcutaneous injection. Size and frequency of dosing will be determined by the AP algorithm. Duration: 3 days.

Drug: Dasiglucagon

GlucaGen

ACTIVE COMPARATOR

Glucagon 1mg/ml solution for subcutaneous injection. Size and frequency of dosing will be determined by the AP algorithm. Duration: 3 days.

Drug: GlucaGen

Interventions

Dasiglucagon DRUG

Use of dasiglucagon in the AP system.

Dasiglucagon

GlucaGen DRUG

Use of GlucaGen in the AP system.

GlucaGen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with diabetes mellitus type 1;
• Treated with the Inreda AP system for a minimum of 1 month;
• Age between 18 and 75 years;
• Adequate contraception is required (only applicable for female participants);
• Willing and able to sign informed consent.
• Treated with SAP or CSII for a minimum of 6 months;
• HbA1c \< 97 mmol/mol;
• BMI \< 35 kg/m2;
• No use of acetaminophen, as this may influence the sensor glucose measurements.

You may not qualify if:

• Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire \[3\], \[4\];
• Pregnancy and/or breastfeeding;
• Use of oral antidiabetic agents;
• Pheochromocytoma;
• Insulinoma;
• Severe liver/heart/renal failure;
• Alcohol abuse;
• Hypersensitivity reactions to dasiglucagon, glucagon or any of the excipients;

Sponsors & Collaborators

• Inreda Diabetic B.V.: lead

Study Sites (1)

ZGT hospital

Almelo, Overijssel, 7609 PP, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

dasiglucagon; Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• G Laverman, MD

  ZGT hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigational Medicinal Product dasiglucagon and control GlucaGen are masked as either treatment A or B. Only the assistant researcher who does the preparation and allocation of the drugs has this key.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three days treatment A, four days wash out period (standard treatment), three days treatment B.

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: July 12, 2022
• Study Start: December 29, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)