Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5527
Source ID: NCT03407599
Associated Drug: Faster Aspart
Title: A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 1
Interventions: DRUG: Faster aspart|DRUG: Insulin aspart (NovoRapid®)
Outcome Measures: Primary: AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours, Calculated based on insulin aspart measured in blood., 0-12 hours | Secondary: AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes, Calculated based on insulin aspart measured in blood., 0-15 minutes|AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes, Calculated based on insulin aspart measured in blood., 0-30 minutes|AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour, Calculated based on insulin aspart measured in blood., 0-1 hour|AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour, Calculated based on insulin aspart measured in blood., 0-1½ hour|AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours, Calculated based on insulin aspart measured in blood., 0-2 hours|Cmax,IAsp, maximum observed serum insulin aspart concentration, Calculated based on insulin aspart measured in blood., 0-12 hours|tmax,IAsp, time to maximum observed serum insulin aspart concentration, Calculated based on insulin aspart measured in blood., 0-12 hours|Onset of appearanceIAsp, time from trial product administration until the first time serum insulinaspart concentration greater than or equal to Lower Limit Of Quantitation (LLOQ), Calculated based on insulin aspart measured in blood., 0-12 hours|Duration of exposureIAsp, time from trial product administration until the first time serum insulin aspart concentration is equal to LLOQ in the terminal part of the curve, Calculated based on insulin aspart measured in blood., 0-12 hours|Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp, Calculated based on insulin aspart measured in blood., 0-12 hours|Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp, Calculated based on insulin aspart measured in blood., 0-12 hours|Mean change in plasma glucose concentration from 0-1 hour after administration, Calculated based on glucose concentration measured in plasma., 0-1 hour|Mean change in plasma glucose concentration from 0-2 hours after administration, Calculated based on glucose concentration measured in plasma., 0-2 hours|Mean change in plasma glucose concentration from 0-6 hours after administration, Calculated based on glucose concentration measured in plasma., 0-6 hours|Change from baseline in plasma glucose concentration 1 hour after administration, Calculated based on glucose concentration measured in plasma., Pre-dose (0 hour), 1 hour|Change from baseline in plasma glucose concentration 2 hours after administration, Calculated based on glucose concentration measured in plasma., Pre-dose (0 hour), 2 hours|Plasma glucose concentration 1 hour after administration, Calculated based on glucose concentration measured in plasma., 1 hour after administration|Plasma glucose concentration 2 hours after administration, Calculated based on glucose concentration measured in plasma., 2 hours after administration|Maximum plasma glucose excursion after administration, Calculated based on glucose concentration measured in plasma., 0-6 hours|Maximum plasma glucose concentration after administration, Calculated based on glucose concentration measured in plasma., 0-6 hours|Time to maximum plasma glucose concentration after administration, Calculated based on glucose concentration measured in plasma., 0-6 hours|Minimum plasma glucose concentration after administration, Calculated based on glucose concentration measured in plasma., 0-6 hours|Number of adverse events, Count of events, From screening day 1 up to the study completion day 68|Number of hypoglycaemic episodes, Count of hypoglycaemic episodes, From screening day 1 up to the study completion day 68
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE1
Enrollment: 46
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-01-08
Completion Date: 2018-07-05
Results First Posted:
Last Update Posted: 2019-06-19
Locations: Novo Nordisk Investigational Site, Hannover, 30173, Germany
URL: https://clinicaltrials.gov/show/NCT03407599