Diabetes Mellitus, Type 1 MedDRA version: 16.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cmax,IAsp, maximum observed serum insulin aspart concentration;Timepoint(s) of evaluation of this end point: - | — |
Countries
Germany
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed