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

Study Overview
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Brief Summary
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A study to compare Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type 2 diabetes who are currently taking oral medications and have not previously taken insulin. Change in HbA1c levels will be reviewed to determine superiority or inferiority of the AIR Inhaled Insulin regimen.

Official Title
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A Phase 3, Open-Label, Crossover Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared With Once-Daily Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes Mellitus on Oral Agents

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 Insulin naive One or more oral antihyperglycemic medications HbA1c greater than or equal to 8.0% and less than or equal to 10.5% Non-smoker Exclusion Criteria: Taking a TZD dose greater than what is indicated Have not taken insulin within 6 months of entry into study Have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry Have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry Have had pneumonia in the 3 months prior to study entry Systemic glucocorticoid therapy Clinical signs or symptoms of liver disease, acute or chronic hepatitis History of renal transplantation Have an active or untreated malignancy Have a current diagnosis or past history of clinically relevant pulmonary disease Taking or have taken exenatide during the 6 weeks prior to study entry

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with insulin glargine and OAM continuation followed by 24 week treatment period with HIIP and OAM continuation 8 week follow up period | Drug: Human Insulin Inhalation Powder<br>* patient specific dose, inhaled, before meals, 24 weeks<br>* Other names: LY041001;Drug: Insulin Glargine<br>* patient specific dose, injectable, before meals, 24 weeks<br>|
| Experimental: 2<br>4 week pretreatment phase consists of continuation of usual OAM therapy 24 week treatment period with HIIP and OAM continuation followed by 24 week treatment period with insulin glargine and OAM continuation 8 week follow up period | Drug: Human Insulin Inhalation Powder<br>* patient specific dose, inhaled, before meals, 24 weeks<br>* Other names: LY041001;Drug: Insulin Glargine<br>* patient specific dose, injectable, before meals, 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint. |  | 56 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in HbA1c from baseline to various timepoints |  | 56 weeks | 
| Insulin dose requirements |  | 56 weeks | 
| Patient-reported outcomes of W-BQ12 |  | screening,baseline, week 12,24, and 48 | 
| Hypoglycemia rate |  | throughout the study | 
| Changes in body weight |  | every visit | 
| Adverse events |  | throughout the study | 
| Safety as assessed by total pulmonary function testing and fasting lipid profile |  | throughout the study | 
| Assess inhaler reliability. |  | throughout the study | 
| Patient Reported outcomes of DSC-R |  | screening,baseline, week 12,24, and 48 | 
| Patient reported outcomes of DTSQS |  | screening,baseline, week 12, 24 and 48 | 
| Patient reported outcome of IDSQ |  | week 12, 24, and 48 | 
| Patient reported outcome of preference questionnaire |  | week 48 | 
| Patient reported outcome of Expectations About Insulin Therapy Questionnaire |  | screening,baseline | 
| Patient reported outcome of Experience with Insulin Therapy Questionnaire |  | week 12, 24 and 48 |