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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: human insulin; Drug: inhaled human insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567775

NN1998-1274

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)