A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System; a Feasibility Study

NL76691.100.22

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.

2023-12-29

2023-12-29

2023-12-29

Withdrawn

Early phase I

Inclusion Criteria: * 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. Since subjects are treated with the Inreda AP, the following inclusion criteria will be met: * 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. Exclusion Criteria: * 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;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Three days treatment A, four days wash out period (standard treatment), three days treatment B.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2024-01-03