A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes
Phase 1
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT01030926
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial was conducted in Europe. The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
- Male or female aged 6-65 years (both inclusive)
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 kg/m^2
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
- Not able or willing to refrain from smoking during the inpatient period
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A1, first period insulin degludec - A2, second period insulin glargine - B1, first period insulin glargine - B2, second period insulin degludec -
- Primary Outcome Measures
Name Time Method Area under the NN1250 concentration-time curve after single dose 0-72 hours after dosing
- Secondary Outcome Measures
Name Time Method Maximum observed NN1250 concentration after single dose 0-72 hours after dosing Time to maximum observed NN1250 concentration after single dose 0-72 hours after dosing
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Hannover, Germany