A trial investigating the pharmacokinetic properties of FIAsp in children, adolescents and adults with type 1 diabetes

• Register: EUCTR
• Last refreshed on: 2 February 2015
• Main ID: EUCTR2011-002104-32-DE
• Date of registration: 10/10/2013
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A trial investigating the pharmacokinetic properties of FIAsp in children, adolescents and adults with type 1 diabetes
• Scientific title: A trial investigating the pharmacokinetic properties of FIAsp in children, adolescents and adults with type 1 diabetes
• Date of first enrolment: 14/11/2014
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002104-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Germany

Contacts

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female aged 6–64 years (both inclusive) at the time of signing informed consent.
2. Type 1 diabetes mellitus (as diagnosed clinically) = 12 months.
3. Body mass index (BMI) for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults = 28.0 kg/m^2.
Are the trial subjects under 18? yes
Number of subjects for this age range: 26
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Diabetes Mellitus, Type 1
MedDRA version: 16.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861

Intervention(s)

Product Name: FIAsp 3ml PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: NovoRapid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: From 0 to 12 hours

Main Objective: To compare the total exposure of FIAsp between children, adolescents and adult subjects with type 1 diabetes.

Primary end point(s): AUCIAsp,0–12h, area under the serum insulin aspart concentration-time curve

Secondary Objective: 1. To compare the maximum concentration of FIAsp between the three different age groups.
2. To compare the effects of age on FIAsp pharmacokinetic and pharmacodynamic properties with the effects of age on NovoRapid® pharmacokinetic and pharmacodynamic properties.

Secondary Outcome(s)

Secondary end point(s): Cmax,IAsp, maximum observed serum insulin aspart concentration

Timepoint(s) of evaluation of this end point: -

Secondary ID(s)

NN1218-3888

Source(s) of Monetary Support

Novo Nordisk A/S