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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567775
• Other study ID #: NN1998-1274
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2007
• Last updated: February 28, 2017
• Start date: October 21, 2002
• Est. completion date: November 20, 2002

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 20, 2002
• Est. primary completion date: November 20, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• human insulin

• inhaled human insulin

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin curve		from 0 to 5 hours post-dosing
Secondary	Maximum serum insulin concentration		in the interval from 0 to 5 hours post-dosing
Secondary	Time to maximum serum insulin concentration		in the interval from 0 to 5 hours post-dosing

External Links

•   Clinical Trials at Novo Nordisk