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

Comparison of Pharmacokinetic Profiles of Human Soluble Insulin With Insulin Inhalation Solution in Paediatric Type 1 Diabetes Mellitus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00567775

Enrollment

Registered

2007-12-05

Start date

2002-10-21

Completion date

2002-11-20

Last updated

2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

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.

Interventions

DRUGhuman insulin

DRUGinhaled human insulin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame
Area under the serum insulin curve	from 0 to 5 hours post-dosing

Secondary

Measure	Time frame
Maximum serum insulin concentration	in the interval from 0 to 5 hours post-dosing
Time to maximum serum insulin concentration	in the interval from 0 to 5 hours post-dosing

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026