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

Conditions: Diabetes Mellitus, Type 1
MedDRA version: 16.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-002104-32-DE

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the total exposure of FIAsp between children, adolescents and adult subjects with type 1 diabetes.;Secondary Objective: 1. To compare the maximum concentration of FIAsp between the three different age groups.<br>2. To compare the effects of age on FIAsp 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 Outcome Measures