A Phase 2 interventional study of Dasiglucagon in Type 1 Diabetes and Hypoglycemia, sponsored by Steno Diabetes Center Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by Steno Diabetes Center Copenhagen · Phase 2, Interventional, and Treatment
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.
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Steno Diabetes Center Copenhagen is the lead sponsor of 111 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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 (80 µg) dasiglucagon to treat or prevent episodes of hypoglycemia.
Drug: Dasiglucagon
Abdominal s.c. administration using a multi-dose reusable pen injector
Difference in percentage of time in range between the two study periods
Sensor glucose level ≥ 3.9 mmol/l and ≤ 10.0 mmol/l
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in percentage of time in hypoglycemia between the two study periods
Sensor glucose level \< 3.9 mmol/l
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in percentage of time in hyperglycemia between the two study periods
Sensor glucose level \> 10 mmol/l
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in coefficient of variation (%) between the two study periods
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference between successful cases (%) of hypoglycemia treatment between the two study periods
Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level \> 3.9 mmol/l 30 minutes post-treatment
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in successful cases (%) of hypoglycemia treatment without subsequent hyperglycemia [sensor glucose level > 10 mmol/l during the first two hours post-treatment] between the two study periods
Initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l AND sensor glucose level \> 3.9 mmol/l 30 minutes post-treatment AND sensor glucose level ≤ 10 mmol/l during the first two hours post-treatment
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in successful cases (%) of hypoglycemia prevention between the two study periods
Initial sensor glucose level \> 3.9 mmol/l AND sensor glucose level \< 3.9 for ≤ 15 consecutive minutes during the first two hours post-treatment
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in time from hypoglycemia treatment to euglycemia between the two study periods
Minutes from initial sensor glucose level ≥ 2.2 mmol/l and ≤ 3.9 mmol/l to sensor glucose level ≥ 3.9 mmol/l
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration
Time frame: 2-week 'dasiglucagon' period
Difference between the average daily carbohydrate intake between the two study periods
Registered on the insulin pump
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference between the average total daily insulin dose between the two study periods
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Difference in the number and intensity of episodes with nausea, headache, stomach-ache, palpitations and injection site pain between the two study periods
Intensity: mild/moderate/severe
Time frame: 2-week 'usual care' period and 2-week 'dasiglucagon' period
Percentage of participants scoring a favorable outcome on the patient-reported outcome questionnaire
Scoring likely OR very likely on a four-point Likert scale
Time frame: At the end-of-study visit (estimated week 6)
Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies
Time frame: Measured 4 weeks after the 'dasiglucagon' period
Number of device failures/malfunctions
Time frame: 2-week 'dasiglucagon' period
Plan to share: No
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Steno Diabetes Center Copenhagen