Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)
Phase 3
Terminated
- Conditions
- Chronic Obstructive Pulmonary DiseaseDiabetes Mellitus, Type 2DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT00472953
- Lead Sponsor
- Novo Nordisk A/S
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 38
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A inhaled human insulin - B insulin aspart -
- Primary Outcome Measures
Name Time Method To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections After one year
- Secondary Outcome Measures
Name Time Method Preprandial Insulin Doses After one year Patient Reported Outcomes After one year Diabetes control measured by change in HbA1c from baseline After one year
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇹🇷Kocaeli, Turkey