Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A 24-month Multicentre, Open-label, Randomised, Parallel Group, Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With Insulin Aspart Administered s.c., Both in Combination With NPH, in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725036
• Other study ID #: NN1998-1496
• Status: Completed
• Phase: Phase 3
• First received: July 29, 2008
• Last updated: February 28, 2017
• Start date: September 2, 2002
• Est. completion date: December 14, 2004

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 Oceania.

The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: December 14, 2004
• Est. primary completion date: December 14, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 1 diabetes

• Current treatment with any insulin in any regimen

• Body mass index (BMI) below 38.0 kg/m2

• HbA1c below or equal to 13.0%

Exclusion Criteria:

• Total daily insulin dosage more than 100 IU/day

• Current acute or chronic pulmonary disease (excluding asthma)

• Recurrent major hypoglycaemia

• Proliferative retinopathy or maculopathy requiring acute treatment

• Smoker

• Chest X-ray with clinically significant abnormalities

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• inhaled human insulin

• insulin aspart

• insulin NPH

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Ashford
Australia	Novo Nordisk Investigational Site	Auckland
Australia	Novo Nordisk Investigational Site	Box Hill
Australia	Novo Nordisk Investigational Site	Broadmeadow	New South Wales
Australia	Novo Nordisk Investigational Site	Camperdown	New South Wales
Australia	Novo Nordisk Investigational Site	Christchurch
Australia	Novo Nordisk Investigational Site	Clayton
Australia	Novo Nordisk Investigational Site	Fremantle	Western Australia
Australia	Novo Nordisk Investigational Site	Garran
Australia	Novo Nordisk Investigational Site	Heidelberg
Australia	Novo Nordisk Investigational Site	Keswick	South Australia
Australia	Novo Nordisk Investigational Site	Parkville
Australia	Novo Nordisk Investigational Site	Perth
Australia	Novo Nordisk Investigational Site	Randwick
Australia	Novo Nordisk Investigational Site	St Leonards	New South Wales
Australia	Novo Nordisk Investigational Site	Stones Corner
Australia	Novo Nordisk Investigational Site	Wollongong	New South Wales
Australia	Novo Nordisk Investigational Site	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term pulmonary safety profiles		during treatment
Secondary	Glycaemic control as measured by HbA1c
Secondary	Incidence of hypoglycaemic episodes
Secondary	Long-term safety profiles (laboratory, ECG, insulin antibodies)
Secondary	Physical examination and body weight and vital signs
Secondary	Adverse events
Secondary	Treatment satisfaction

External Links

•   Clinical Trials at Novo Nordisk