Overview

Comparison of Human Insulin to Insulin Inhalation Solution in Children With Type 1 Diabetes

Status:
Completed
Trial end date:
2002-11-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin, Globin Zinc
Criteria
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