Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes

• Status: Completed
• Trial end date: 2021-01-04
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to compare the efficacy of low-dose dasiglucagon (Zealand Pharma, Denmark) to oral carbohydrate consumption for prevention of s.c. insulin-induced hypoglycemia in CSII- and MDI-treated people with type 1 diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center Copenhagen

Criteria

Inclusion Criteria:

• Age 18-64 years

• Duration of T1D ≥ 3 years

• Use of CSII or MDI therapy for ≥ 6 months

• Current use of Novorapid (change from another fast-acting insulin to Novorapid prior to study initiation is allowed)

• HbA1c ≤ 8.0%

• Regular use of carbohydrate counting in the judgement of the investigator

Exclusion Criteria:

• Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start

• History of allergy or intolerance to glucagon or glucagon-like products

• Patients with pheochromocytoma

• Clinically significant ECG abnormalities

• Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)

• Inability to understand the individual information and to give informed consent

• Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject

• Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the individual unsuitable for study participation