Status:
COMPLETED
A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
6-64 years
Phase:
PHASE1
Brief Summary
The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children \[6-11 years\], adolescents \[12-17 years\] and adults \[18-64 ...
Eligibility Criteria
Inclusion
- Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
- Diagnosed with type 1 diabetes greater than or equal to 12 months 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 less than or equal to 28.0 kg/sqm
Exclusion
- 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
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03407599
Start Date
January 8 2018
End Date
July 5 2018
Last Update
June 19 2019
Active Locations (1)
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1
Novo Nordisk Investigational Site
Hanover, Germany, 30173