Clinical trial NCT00725036: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Long term pulmonary safety profiles
timeFrame: during treatment
Secondary outcomes:
measure: Glycaemic control as measured by HbA1c
measure: Incidence of hypoglycaemic episodes
measure: Long-term safety profiles (laboratory, ECG, insulin antibodies)
measure: Physical examination and body weight and vital signs
measure: Adverse events
measure: Treatment satisfaction
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Camperdown
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: Keswick
country: Australia
facility: Novo Nordisk Investigational Site
state: South Australia
city: Fremantle
country: Australia
facility: Novo Nordisk Investigational Site
state: Western Australia
city: Ashford
country: Australia
facility: Novo Nordisk Investigational Site
city: Auckland
country: Australia
facility: Novo Nordisk Investigational Site
city: Box Hill
country: Australia
facility: Novo Nordisk Investigational Site
city: Christchurch
country: Australia
facility: Novo Nordisk Investigational Site
city: Clayton
country: Australia
facility: Novo Nordisk Investigational Site
city: Garran
country: Australia
facility: Novo Nordisk Investigational Site
city: Heidelberg
country: Australia
facility: Novo Nordisk Investigational Site
city: Parkville
country: Australia
facility: Novo Nordisk Investigational Site
city: Perth
country: Australia
facility: Novo Nordisk Investigational Site
city: Randwick
country: Australia
facility: Novo Nordisk Investigational Site
city: Stones Corner
country: Australia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: