Pen-Administered Dasiglucagon for Prevention and Treatment of Low Blood Glucose Levels in People with Type 1 Diabetes

Phase 1

• Conditions: Type 1 diabetes; MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2020-005745-16-DK
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-04
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

•Age = 18 years
•T1D = 2 years
•Use of insulin pump therapy (without sensor-augmented insulin suspension/adjustment functionality) = 6 months
•Use of CGM (real-time or intermittently scanned) = 3 months and = 70% during the previous 14 days
•HbA1c = 70 mmol/l (8.5%)
•Performs aerobic exercise on a regular basis (= 2 times per week; self-reported) and desires to exercise per American Diabetes Association guidelines (150 minutes per week) during the study.
•Use of carbohydrate counting and bolus calculator (self-reported)
•Sensor glucose level (SGL) < 3.9 mmol/l on = 4/14 previous days assessed by CGM data

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

•Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
•Know or suspected allergies to glucagon or related products
•History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients (refer to Table 1 in the Investigators brochure)
•Patients with pheochromocytoma or insulinoma
•Hypoglycemia unawareness
•Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception)
•Inability to understand the individual information and to give informed consent
•Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
•Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose (80 µg) dasiglucagon administered via an investigational trial device (a multi-dose reusable pen injector) in preventing and treating mild hypoglycemia in insulin pump-treated people type 1 diabetes;Secondary Objective: Not applicable;Primary end point(s): •Percentage of time in target glucose range [SGL = 3.9 mmol/l and = 10.0 mmol/l];Timepoint(s) of evaluation of this end point: From start (day 1) to end (day 14) of each intervention period.