Clinical trial NCT03407599: A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
Official title: A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 46
Sex: ALL
Minimum age (years): 6
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children \[6-11 years\], adolescents \[12-17 years\] and adults \[18-64 years\]) who have diabetes. The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink. The effects of faster aspart will be compared to the effects of NovoRapid®.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
* Diagnosed with type 1 diabetes greater than or equal to 12 months prior to the day of screening
* Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults less than or equal to 28.0 kg/sqm

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Primary outcomes:
measure: AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
timeFrame: 0-12 hours
Secondary outcomes:
measure: AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes
timeFrame: 0-15 minutes
measure: AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes
timeFrame: 0-30 minutes
measure: AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour
timeFrame: 0-1 hour
measure: AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour
timeFrame: 0-1½ hour
measure: AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours
timeFrame: 0-2 hours
measure: Cmax,IAsp, maximum observed serum insulin aspart concentration
timeFrame: 0-12 hours
measure: tmax,IAsp, time to maximum observed serum insulin aspart concentration
timeFrame: 0-12 hours
measure: 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)
timeFrame: 0-12 hours
measure: 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
timeFrame: 0-12 hours
measure: Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp
timeFrame: 0-12 hours
measure: Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp
timeFrame: 0-12 hours
measure: Mean change in plasma glucose concentration from 0-1 hour after administration
timeFrame: 0-1 hour
measure: Mean change in plasma glucose concentration from 0-2 hours after administration
timeFrame: 0-2 hours
measure: Mean change in plasma glucose concentration from 0-6 hours after administration
timeFrame: 0-6 hours
measure: Change from baseline in plasma glucose concentration 1 hour after administration
timeFrame: Pre-dose (0 hour), 1 hour
measure: Change from baseline in plasma glucose concentration 2 hours after administration
timeFrame: Pre-dose (0 hour), 2 hours
measure: Plasma glucose concentration 1 hour after administration
timeFrame: 1 hour after administration
measure: Plasma glucose concentration 2 hours after administration
timeFrame: 2 hours after administration
measure: Maximum plasma glucose excursion after administration
timeFrame: 0-6 hours
measure: Maximum plasma glucose concentration after administration
timeFrame: 0-6 hours
measure: Time to maximum plasma glucose concentration after administration
timeFrame: 0-6 hours
measure: Minimum plasma glucose concentration after administration
timeFrame: 0-6 hours
measure: Number of adverse events
timeFrame: From screening day 1 up to the study completion day 68
measure: Number of hypoglycaemic episodes
timeFrame: From screening day 1 up to the study completion day 68
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: