Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

Study Overview
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Brief Summary
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A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus. This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes. The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.

Official Title
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A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Human Insulin Inhalation Powder
* Drug: Injectable insulin
* Drug: Insulin Glargine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes for at least 24 months Have an HbA1c less than or equal to 11% Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months Non-smoker Exclusion Criteria: Require a daily total insulin dosage greater than 150 U at screening Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease Systemic glucocorticoid therapy Clinical signs or symptoms of liver disease, acute or chronic hepatitis History of lung transplantation and/or lung cancer Diagnosed with pneumonia in the 3 months prior to screening History of renal transplantation Active or untreated malignancy

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: 1<br> | Drug: Human Insulin Inhalation Powder<br>* patient specific dose, inhaled, before meals, 6 months<br>* Other names: LY041001;Drug: Insulin Glargine<br>* patient specific dose, injectable, before meals, 6 months<br>|
| Active Comparator: 2<br> | Drug: Injectable insulin<br>* patient specific dose, injected, before meals, 6 months<br>Drug: Insulin Glargine<br>* patient specific dose, injectable, before meals, 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin dose requirements |  | throughout the study | 
| Insulin antibody binding levels |  | baseline, 1 month, 6 months, follow-up | 
| To compare HbAlc change |  | 6 months | 
| To assess rate and incidence of hypoglycemia |  | 6 months |