Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups: Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day. Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.

Official Title
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A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder
* Drug: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus for at least 6 months Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening. Patients who have been treated with the following regimen: One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones [TZDs]), AND have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months, AND are candidates for insulin therapy, in the opinion of the investigator. Exclusion Criteria: Pregnancy Smoker History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry Diagnosed with pneumonia in the 3 months prior to screening Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry History of renal transplantation History of lung transplantation Active or untreated malignancy Treated with Incretin mimetics

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: simplified diabetes regimen starting with a fixed dose of Human Insulin Inhalation Powder<br>* patient specific dose, inhaled, before meals,6 months<br>* Other names: LY041001;|
| Experimental: 2<br> | Drug: intensive diabetes management starting with an adjusted dose of Human Insulin Inhalation Powder<br>* patient specific dose, inhaled, before meals, 6 months<br>* Other names: LY 041001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate that a simple approach for adding AIR® Inhaled Insulin to oral antihyperglycemic medication can achieve glycemic control similar to a more aggressive approach. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in HbA1c from baseline to various endpoints. |  | 6 months | 
| Patient safety |  | throughout the study | 
| Patient reported outcome from W-BQ12 |  | screening,baseline,month 6 | 
| Treatment satisfaction |  | 6 months | 
| Insulin dose |  | throughout the study | 
| Patient reported outcome from DSC-R |  | screening,baseline, month 6 | 
| Patient reported outcome from DTSQS |  | screening,baseline, month 6 | 
| Patient reported outcome from IDSQ |  | Month 1, 2 and 6 | 
| Patient reported outcome from Expectations About Insulin Therapy Questionnaire |  | baseline, screening, month 6 |