Clinical trial NCT00472953: Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)
Official title: Inhaled Pre-prandial Human Insulin Versus Subcutaneous Injected Insulin Aspart in Subjects With Diabetes and Chronic Obstructive Pulmonary Disease: A 52-week Open Label, Multicentre, Randomized, 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
Chronic Obstructive Pulmonary Disease
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-05-14
Enrollment: 38
Sex: ALL
Minimum age (years): 30
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 and South America. A one-year clinical trial to compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with type 1 or type 2 diabetes and chronic obstructive pulmonary disease (COPD).

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:

* Chronic Obstructive Pulmonary Disease
* Type 1 or type 2 diabetes
* HbA1c lower or equal to 11.0 %
* Body Mass Index (BMI) lower or equal to 40.0 kg/m2

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Current smoking or smoking within the last 6 months
* Other pulmonary disease including asthma
* Proliferative retinopathy or maculopathy requiring acute treatment

Primary outcomes:
measure: To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections
timeFrame: After one year
Secondary outcomes:
measure: Patient Reported Outcomes
timeFrame: After one year
measure: Diabetes control measured by change in HbA1c from baseline
timeFrame: After one year
measure: Preprandial Insulin Doses
timeFrame: After one year
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Ciudad de Buenos Aires
country: Argentina
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: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
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
city: Changhua
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Chiayi City
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Taipei
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Erzurum
country: Turkey
facility: Novo Nordisk Investigational Site
city: Gaziantep
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Kocaeli
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: