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Clinical Trial Details

Trial ID: L3743
Source ID: NCT04764968
Associated Drug: Dasiglucagon
Title: Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes|Hypoglycemia
Interventions: DRUG: Dasiglucagon
Outcome Measures: Primary: Difference in percentage of time in range between the two study periods, Sensor glucose level ≥ 3.9 mmol/l and ≤ 10.0 mmol/l, 2-week 'usual care' period and 2-week 'dasiglucagon' period | Secondary: Difference in percentage of time in hypoglycemia between the two study periods, Sensor glucose level \< 3.9 mmol/l, 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, 2-week 'usual care' period and 2-week 'dasiglucagon' period|Difference in coefficient of variation (%) between the two study periods, 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, 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, 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, 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, 2-week 'usual care' period and 2-week 'dasiglucagon' period|Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration, 2-week 'dasiglucagon' period|Difference between the average daily carbohydrate intake between the two study periods, Registered on the insulin pump, 2-week 'usual care' period and 2-week 'dasiglucagon' period|Difference between the average total daily insulin dose between the two study periods, 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, 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, At the end-of-study visit (estimated week 6)|Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies, Measured 4 weeks after the 'dasiglucagon' period | Other: Number of device failures/malfunctions, 2-week 'dasiglucagon' period
Sponsor/Collaborators: Sponsor: Steno Diabetes Center Copenhagen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-04-27
Completion Date: 2022-01-28
Results First Posted:
Last Update Posted: 2022-09-07
Locations: Steno Diabetes Center Copenhagen, Gentofte, 2820, Denmark
URL: https://clinicaltrials.gov/show/NCT04764968