A research study of how fast-acting insulin aspart works in the body of children, young people and grown-ups with type 1 diabetes

A trial comparing the pharmacokinetic properties of fast-acting insulin aspart between children, adolescents and adults with type 1 diabetes

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002014-31-DE

Enrollment

Registered

2017-10-05

Start date

2017-10-26

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1 MedDRA version: 20.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861

Interventions

Trade Name: Fiasp® Pharmaceutical Form: Solution for injection INN or Proposed INN: Insulin Aspart CAS Number: 116094-23-6 Other descriptive name: INSULIN ASPART Concentration unit: U/ml unit(s)/milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female aged 6–64 years (both inclusive) at the time of signing informed consent. - Diagnosed with type 1 diabetes for 12 months or longer 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 equal to or below 28.0 kg/sqm. Are the trial subjects under 18? yes Number of subjects for this age range: 31 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the total exposure of faster aspart between children, adolescents and adult subjects with type 1 diabetes;Secondary Objective: 1. To compare the maximum concentration of faster aspart between the three different age groups 2. To compare the effects of age on faster aspart pharmacokinetic and pharmacodynamic properties with the effects of age on NovoRapid® pharmacokinetic and pharmacodynamic properties;Primary end point(s): AUCIAsp,0–12h, area under the serum insulin aspart concentration-time curve;Timepoint(s) of evaluation of this end point: From 0 to 12 hours	—

Measure

Time frame

Main Objective: To compare the total exposure of faster aspart between children, adolescents and adult subjects with type 1 diabetes;Secondary Objective: 1. To compare the maximum concentration of faster aspart between the three different age groups 2. To compare the effects of age on faster aspart pharmacokinetic and pharmacodynamic properties with the effects of age on NovoRapid® pharmacokinetic and pharmacodynamic properties;Primary end point(s): AUCIAsp,0–12h, area under the serum insulin aspart concentration-time curve;Timepoint(s) of evaluation of this end point: From 0 to 12 hours

—

Secondary

Measure	Time frame
Secondary end point(s): Cmax,IAsp, maximum observed serum insulin aspart concentration;Timepoint(s) of evaluation of this end point: NA	—

Countries

Germany

Contacts

Public ContactGlobal Clinical Registry (GCR,1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026