Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes
Phase 2
Completed
- Conditions
- Diabetes Mellitus, Type 1Diabetes
- Registration Number
- NCT00567775
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic profile of two different methods of insulin administration in children with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Type 1 diabetes
- Treatment for at least 12 months
- HbA1c lesser or equal to 11.0%
- Body weight between 25 and 80 Kg
- Capable to use the device
Exclusion Criteria
- Any diseases other than diabetes requiring prescriptive medication
- Known or suspected allergy to trial product or related products
- Active proliferative retinopathy as judged by the Investigator
- Recurrent severe hypoglycaemia as judged by the Investigator
- The receipt of any investigational drug within 4 weeks prior to this trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Area under the serum insulin curve from 0 to 5 hours post-dosing
- Secondary Outcome Measures
Name Time Method Time to maximum serum insulin concentration in the interval from 0 to 5 hours post-dosing Maximum serum insulin concentration in the interval from 0 to 5 hours post-dosing
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇰Glostrup, Denmark