Status:
TERMINATED
Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
30+ years
Phase:
PHASE3
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 dia...
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 signi...
Eligibility Criteria
Inclusion
- 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
- Recurrent severe hypoglycaemia
- Current smoking or smoking within the last 6 months
- Other pulmonary disease including asthma
- Proliferative retinopathy or maculopathy requiring acute treatment
Key Trial Info
Start Date :
May 15 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2008
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00472953
Start Date
May 15 2007
End Date
March 5 2008
Last Update
March 1 2017
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Buenos Aires, Argentina, B1636DSU
2
Novo Nordisk Investigational Site
Buenos Aires, Argentina, C1425AGC
3
Novo Nordisk Investigational Site
Ciudad de Buenos Aires, Argentina, 1280
4
Novo Nordisk Investigational Site
Chandigarh, Punjab, India, 160012