Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

Official Title
-----------------
A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.

Conditions
-----------------
Diabetes Mellitus, Type 2

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Non smoker Normal lung function Exclusion Criteria: Pulmonary, hepatic, or renal disease Congestive heart failure Active malignancy Systemic glucocorticoid therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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, 24 months<br>* Other names: LY041001;|
| Active Comparator: 2<br> | Drug: Injectable insulin<br>* patient specific dose, injectable, before meals, 24 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin |  | 24 months | 
| To compare inhaled human insulin to injectable insulin over time with respect to change on body weight |  | baseline and every visit | 
| To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction |  | baseline, 6 months, 12 months, 18 months, 24 months | 
| To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c |  | baseline and every visit | 
| To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia |  | throughout the study | 
| To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements |  | 24 months | 
| To test dose titration methods |  | 6 months | 
| To assess inhaler reliability |  | throughout the study | 
| To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients |  | 3 months, 6 months |