Status:
COMPLETED
Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Type 1 Diabetes
Hypoglycemia
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief 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...
Detailed Description
Near-normalization of blood glucose levels through intensive insulin therapy has shown to reduce the risk of diabetes late complications, but the approach is associated with two major side effects: hy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04449692
Start Date
July 2 2020
End Date
January 4 2021
Last Update
February 9 2021
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark, 2820