A Study for Patients With Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the blood sugar level.

Official Title
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A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Insulin glargine
* Drug: Human Insulin Inhalation Powder
* Drug: Injectable Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes mellitus for at least 24 months Injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months HbA1c equal or less than 11 % Nonsmokers, had not smoked for at least 6 months and agree not to smoke (cigars, cigarettes or pipes) or use smokeless tobacco for the duration of the study Satisfactory lung function results to meet the requirement of the study Exclusion Criteria: Previously received any form of inhaled insulin Require a daily total insulin dosage greater than 100 U Have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease History or presence of liver disease History or presence of kidney disease

Ages Eligible for Study
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Minimum Age: 20 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> | Drug: Insulin glargine<br>* Patient specific, injected, daily, 24 weeks<br>Drug: Human Insulin Inhalation Powder<br>* patient specific dose, inhaled, before meals,12 weeks<br>* Other names: LY041001;Drug: Injectable Insulin<br>* Patient specific dose,injected, before meals, 12 weeks<br>|
| Experimental: 2<br> | Drug: Insulin glargine<br>* Patient specific, injected, daily, 24 weeks<br>Drug: Human Insulin Inhalation Powder<br>* patient specific dose, inhaled, before meals,12 weeks<br>* Other names: LY041001;Drug: Injectable Insulin<br>* Patient specific dose,injected, before meals, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline |  | 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who achieve an HbA1c < 7% and <= 6.5% |  | 12 and 24 weeks | 
| Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses |  | at each visit | 
| 8-point self monitoring blood glucose profiles |  | 12 and 24 weeks | 
| Two hour glucose excursions for the morning, midday, and evening meals |  | 12 and 24 weeks | 
| Inhaler reliability |  | throughout the study | 
| Patient-reported treatment satisfaction and insulin delivery satisfaction |  | 12 and 24 weeks | 
| Preference for the study therapies |  | week 24 |