Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD

Study Overview
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Brief Summary
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Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month follow up period.

Official Title
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A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma

Conditions
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Asthma, Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Human Insulin Inhalation Powder
* Drug: injected insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 or type 2 diabetes asthma or COPD Exclusion Criteria: Current smoking habit

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, 12 months<br>* Other names: LY041001;|
| Active Comparator: 2<br> | Drug: injected insulin<br>* patient specific dose, injected, before meals, 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator. |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on the response to bronchodilator as measured by change between pre- and post- bronchodilator FEV1 and FVC |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco. |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by insulin antibody levels, adverse events, and episodes of hypoglycemia |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by chest x-rays. |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the St. George's Respiratory Questionnaire. |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the Six-Minute Walk Test with the Borg CR10 Scale. |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on proportion of patients who achieve or maintain HbA1c of less than or equal to 6.5% and who achieve or maintain HbA1c of < 7 %. |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and inj. insulin on proportion of pts with type 2 on oral agent(s) rand. to Human Insulin Inhalation Powder only or glargine only who do not reach an HbA1c <7.5 % after six months. |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on glycemic control as assessed by the 8-point-self monitored blood glucose profiles |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on insulin dose requirements ( including total, basal, and/or bolus insulin) |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on patient-reported outcomes questionnaires to assess general health status. |  | 12 months | 
| To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization. |  | 12 months | 
| To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder. |  | throughout the study | 
| To explore the impact of Human Insulin Inhalation Powder on peak flow and peak flow variability in the study with asthma patients. |  | 12 months |