Clinical trial NCT00523042: Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma
Official title: Inhaled Preprandial Human Insulin With the AERx® iMS Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Asthma: A 52-week, Open-label, Multinational, Randomised, Parallel Trial to Investigate Long-term Safety
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Asthma
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-08-30
Enrollment: 10
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 Europe, Asia, Oceania and the United States of America (USA).

This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.

Detailed description: The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes
* Treatment with insulin and/or oral anti-diabetic drugs
* Asthma for at least 6 months
* Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years
* HbA1C less than or equal to 11.0 %
* Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria:

* Current smoking or smoking within the last 6 months
* Other current acute or chronic pulmonary disease excluding asthma
* Recurrent severe hypoglycaemia
* Proliferative retinopathy or maculopathy

Primary outcomes:
measure: Changes in lung function, chest X-rays, or asthma exacerbation frequency
timeFrame: after 52 weeks of treatment
Secondary outcomes:
measure: Diabetes control measured by change in HbA1c
timeFrame: from baseline to end of treatment
measure: Laboratory assessments (biochemistry, insulin antibodies, blood count)
timeFrame: from baseline to end of treatment
measure: Preprandial insulin doses
timeFrame: for the duration of the trial
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: New Orleans
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Kansas City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Ogden
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Spokane
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
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: Keswick
country: Australia
facility: Novo Nordisk Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: East Ringwood
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Auchenflower
country: Australia
facility: Novo Nordisk Investigational Site
city: Kippa Ring
country: Australia
facility: Novo Nordisk Investigational Site
city: Belgrade
country: Former Serbia and Montenegro
facility: Novo Nordisk Investigational Site
city: Chandigarh
country: India
facility: Novo Nordisk Investigational Site
state: Punjab
city: Vellore
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
city: Pune
country: India
facility: Novo Nordisk Investigational Site
city: Cheras
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kota Bharu, Kelantan
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Pulau Pinang
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Lubochna
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Moldava nad Bodvou
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Zilina
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Zilina
country: Slovakia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: