Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes

NCT ID: NCT04764968

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-27
• Study Completion Date: 2022-01-28

Brief Summary

The aim of the study is to evaluate the efficacy, safety and feasibility of outpatient-utilization of low-dose dasiglucagon administered via a multi-dose reusable pen injector in preventing and treating mild hypoglycemia in insulin pump-treated people with type 1 diabetes.

Detailed Description

A randomized, open-label, two-arm, two-week crossover study will be conducted to assess the study objectives. The study will enroll 24 participants with insulin pump-treated type 1 diabetes. Upon study enrollment, participants will complete two consecutive 2-week periods - a 'usual care' period and 'dasiglucagon' period. During the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension. During the 'dasiglucagon' period, participants will use pen-administered low-dose dasiglucagon to treat or prevent episodes of hypoglycemia.

Conditions

Type 1 Diabetes; Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual care

During the 'usual care' period, participants will manage episodes of manifest or impending hypoglycemia as usual, e.g. through carbohydrate consumption or manual insulin pump suspension.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Dasiglucagon

During the 'dasiglucagon' period, participants will use pen-administered low-dose (80 µg) dasiglucagon to treat or prevent episodes of hypoglycemia.

Group Type: EXPERIMENTAL

Dasiglucagon

Intervention Type: DRUG

Abdominal s.c. administration using a multi-dose reusable pen injector

Interventions

Dasiglucagon

Abdominal s.c. administration using a multi-dose reusable pen injector

Intervention Type: DRUG

Eligibility Criteria

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 < 3.9 mmol/l on ≥ 4/14 previous days assessed by CGM data

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
• Known or suspected allergies to glucagon or related products
• History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients
• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Laugesen, MD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Locations

Steno Diabetes Center Copenhagen

Gentofte Municipality, , Denmark

Countries

Denmark

References

Laugesen C, Ranjan AG, Schmidt S, Norgaard K. Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial. Diabetologia. 2023 Jul;66(7):1208-1217. doi: 10.1007/s00125-023-05909-4. Epub 2023 Apr 11.

Reference Type: DERIVED

PMID: 37037948 (View on PubMed)

Other Identifiers

H-21000002

Identifier Type: OTHER

Identifier Source: secondary_id

2020-005745-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

77119

Identifier Type: -

Identifier Source: org_study_id