Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 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 Mealtime Insulin With the AERx® iDMS Versus Subcutaneous Injected Insulin Aspart Both in Combination With Insulin Detemir in Type 1 Diabetes: A 104 Week, Open-Label, Multicenter, Randomised, Parallel Trial (Followed by a Twelve-Week Re-Randomised Extension) To Investigate Safety and Efficacy

Conditions
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Diabetes, Diabetes Mellitus, Type 1

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes HbA1c less than or equal to 11% Body mass index (BMI) less than or equal to 40.0 kg/m2 Exclusion Criteria: Total daily insulin dosage more than 100 IU or U/day. Current smoking or smoking within the last 6 months Impaired hepatic or renal function Cardiac problems Uncontrolled hypertension Current proliferative retinopathy or maculopathy requiring acute treatment

Ages Eligible for Study
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Minimum Age: 18 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, NN304;|
| Active Comparator: B<br> | Drug: insulin detemir<br>* Injection s.c., 50% of daily dose<br>* Other names: Levemir, NN304;Drug: insulin aspart<br>* Treat-to-target dose titration scheme, injection s.c.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | After 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | after 52 weeks | 
| Antibodies |  | after 52 weeks | 
| Hypoglycemia |  | For the duration of the trial | 
| Insulin doses |  | For the duration of the trial | 
| Pulmonary Function |  | For the duration of the trial | 
| Fasting plasma glucose |  | after 52 weeks |