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CompletedNCT00567775Updated Mar 1, 2017

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

A Phase 2 interventional study of human insulin and inhaled human insulin in Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Denmark. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 1 month after the study started (first participant enrolled Oct 2002, registered Nov 2007).
Phase
Phase 2
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
6 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 27 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Interventions

  • Drughuman insulin

    Also known as: Actrapid®, Novolin® R

  • Druginhaled human insulin
06

What researchers measure

Primary outcomes

  1. Area under the serum insulin curve

    Time frame: from 0 to 5 hours post-dosing

Secondary outcomes

  1. Maximum serum insulin concentration

    Time frame: in the interval from 0 to 5 hours post-dosing

  2. Time to maximum serum insulin concentration

    Time frame: in the interval from 0 to 5 hours post-dosing

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Glostrup, 2600, Denmark
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00567775
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 5, 2007
Start date
Oct 21, 2002
Primary completion
Nov 20, 2002
Completion
Nov 20, 2002
Last update
Mar 1, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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