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Clinical Trial Details

Trial ID: L2661
Source ID: NCT04449692
Associated Drug: Dasiglucagon
Title: Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes|Hypoglycemia
Interventions: DRUG: Dasiglucagon|OTHER: Carbohydrate (dextrose tablets)
Outcome Measures: Primary: Difference between study visits in time (min) in hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7) | Secondary: Difference between study visits in incidence rate of hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in incidence rate of level 2 hypoglycemia (plasma glucose < 3.0 mmol/l) from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in incidence rate of rebound hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in nadir plasma glucose concentration from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in peak plasma glucose concentration from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in incremental peak in plasma glucose concentration from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in mean plasma glucose concentration from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in time (min) from intervention to first increase in plasma glucose concentration of 1.1 mmol/l, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in plasma glucose Area Under the Curve (AUC) from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in time (min) to peak plasma glucose concentration from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in time (min) in range (plasma glucose ≥ 3.9 mmol/l and 10.0 mmol/l) from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in time (min) in hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in time (%) in hypoglycemia (plasma glucose < 3.9 mmol/l) (per protocol) from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in incidence rate of rescue carbohydrate administration from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in time (min) to rescue carbohydrate administration from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in plasma dasiglucagon Area Under the Curve (AUC) from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in peak plasma dasiglucagon concentration from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in time to peak plasma dasiglucagon concentration from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in serum insulin concentration at visit start (t = 0) and immediately before administration of the intervention (t-intervention = 0), Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in serum insulin AUC from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in dose (units) of insulin bolus at study start (t = 0), Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in change in Edinburgh Hypoglycemia Symptoms Scale (EHSS) from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in change in visual analogue scale (VAS) for nausea, headache, stomach ache, injection site pain, palpitations and hunger from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)|Difference between study visits in incidence rate of vomiting from 0-180 minutes post-intervention, Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)
Sponsor/Collaborators: Sponsor: Steno Diabetes Center Copenhagen
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2020-07-02
Completion Date: 2021-01-04
Results First Posted:
Last Update Posted: 2021-02-09
Locations: Steno Diabetes Center Copenhagen, Gentofte, 2820, Denmark
URL: https://clinicaltrials.gov/show/NCT04449692