Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 Diabetes.

Detailed Description
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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.

Official Title
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Inhaled Pre-prandial Human Insulin With the AERx® iDMS Versus s.c. Insulin Aspart in Type 2 Diabetes: A 104 Week, Open-label, Multicenter, Randomised, Trial Followed by a 12 Week Re-randomised Extension to Investigate Safety and Efficacy

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: inhaled human insulin
* Drug: insulin detemir
* Drug: insulin aspart
* Drug: insulin aspart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Currently treated with insulin Body mass index of (BMI) less than or equal to 40.0 kg/m2 HbA1c less than or equal to 11.0% Exclusion Criteria: Total daily insulin dosage less than or equal to 100 IU or U/day Current smoking or smoking within the last 6 months Cardiac problems Uncontrolled hypertension Current proliferative retinopathy or maculopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: inhaled human insulin<br>* Treat-to-target dose titration scheme, inhalation.<br>Drug: insulin detemir<br>* Injection s.c., 50% of daily dose.<br>* Other names: Levemir;|
| Active Comparator: B<br> | Drug: insulin detemir<br>* Injection s.c., 50% of daily dose.<br>* Other names: Levemir;Drug: insulin aspart<br>* Treat-to-target dose titration scheme, injection s.c.<br>|
| Active Comparator: C<br> | Drug: insulin detemir<br>* Injection s.c., 50% of daily dose.<br>* Other names: Levemir;Drug: insulin aspart<br>* Treat-to-target dose titration scheme, injection s.c.<br>Drug: insulin aspart<br>* Treat-to-target dose titration scheme, injection s.c. After 2 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment difference in HbA1c |  | After 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | For the duration of the trial | 
| Blood glucose |  | After 52, 104 and 116 weeks of treatment | 
| Body weight |  | During treatment | 
| Lung function |  | After 52, 104 and 116 weeks of treatment | 
| Hypoglycaemia |  | From 12 weeks of treatment |