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

Phase 1

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 20.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-002014-31-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-05
• Study Completion: 2018-07-05
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 43

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

- 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.

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 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<br>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 Outcome Measures

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