Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder [also known as AIR® Inhaled Insulin][AIR® is a registered trademark of Alkermes,Inc.] in patients with Type 2 diabetes who are currently being treated with once daily insulin glargine injections. The present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily insulin glargine injections.

Official Title
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A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients With Type 2 Diabetes Treated With Once-Daily Insulin Glargine

Conditions
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Diabetes Mellitus, Type 2

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes mellitus one or more oral antihyperglycemic medications once-daily insulin glargine HbA1c greater than or equal to 7.5 and less than or equal to 10.5% Non-smoker Exclusion Criteria: taking a TZD dose greater than what is indicated more than two episodes of severe hypoglycemia during the 6 months prior Have had a lower respiratory infection in the 3 months prior systemic glucocorticoid therapy clinical signs or symptoms of liver disease, acute or chronic hepatitis history of renal transplantation Have an active or untreated malignancy Require more than 150 U/day of insulin glargine

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>Intensified Glargine | Drug: Insulin Glargine<br>* patient specific dose, injectable, before meals, 52 weeks<br>|
| Experimental: 2<br>HIIP | Drug: Human Insulin Inhalation Powder<br>* patient specific dose, inhaled, before meals, 52 weeks<br>* Other names: LY041001;|
| Experimental: 3<br>Intensified Glargine plus HIIP | Drug: Human Insulin Inhalation Powder<br>* patient specific dose, inhaled, before meals, 52 weeks<br>* Other names: LY041001;Drug: Insulin Glargine<br>* patient specific dose, injectable, before meals, 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure changes in HbA1c over time |  | 24 weeks | 
| To assess insulin dose requirements |  | 24 and 52 weeks | 
| To assess rate and incidence of hypoglycemia |  | 24 and 52 weeks |