Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus.

Study Overview
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Brief Summary
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This is a research study of a study drug known as LY041001 or human insulin inhalation powder (HIIP). HIIP is a powder form of insulin made to be inhaled through the mouth and into the lungs using a special handheld device.

Official Title
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Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: insulin
* Drug: human insulin inhalation powder (HIIP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: You are at least 18 years old. You have had type 1 diabetes for at least 2 years. You are injecting insulin lispro (Humalog), an insulin lispro mixture (Humalog Mixture), regular human insulin mixture (Humulin mixture) before meals using a syringe or injection pen, not an insulin pump. If you are female and could become pregnant, you test negative for pregnancy based on blood test at the beginning of the study, do not intend to become pregnant, and agree to use a form of birth control approved by the investigator during the study. You have not smoked for at least 1 year, and you agree not to smoke or use smokeless tobacco during the study. Exclusion Criteria: You have used an experimental drug during the last 30 days or have ever taken part in a study of any type of inhaled insulin. You have a history of asthma or allergies. You have a chronic cough. You have had a kidney transplant, are on dialysis, or have poor kidney function. You have a history of chest pain, heart attack, or you have a heart condition that limits your physical activity due to discomfort.

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: A<br> | Drug: insulin<br>* Administer subcutaneous regular human insulin 30 to 60 minutes before meals, or administer insulin lispro within 15 minutes before meals. Inject into abdomen only.<br>* Other names: LY041001;|
| Active Comparator: B<br> | Drug: human insulin inhalation powder (HIIP)<br>* Administer HIIP within 15 minutes before meals. Administer doses in one-capsule increments equivalent to approximately 2 IU or 6 IU of subcutaneous insulin. Target treatment goals during the treatment sequence are the same as for patients using preprandial injectable insulin<br>* Other names: LY041001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| test the hypothesis that preprandial HIIP plus insulin glargine is noninferior to preprandial injectable insulin (regular human insulin or insulin lispro) plus insulin glargine with respect to HbA1c |  | 12 weeks per therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the pharmacokinetics of test doses of preprandial HIIP and preprandial injectable insulin (regular human insulin or insulin lispro) administered to a subgroup of patients |  |  | 
| compare 7-point self-monitored blood glucose profiles (blood glucose measurements before & 2 hours after start of morning, midday, evening meals, and blood glucose measurement at bedtime) for preprandial HIIP and preprandial inject |  |  | 
| assess the safety of HIIP using pulmonary function tests, chest x rays, insulin antibody titers, adverse events (AEs), and episodes of hypoglycemia |  |  | 
| assess symptoms of diabetes, patient vitality, and patient satisfaction with the diabetes treatments |  |  | 
| compare insulin dose requirements (both preprandial and basal insulin [insulin glargine]) of patients administering preprandial HIIP and preprandial injectable insulin (regular human insulin or insulin lispro |  |  | 
| assess insulin inhaler reliability |  |  | 
| assess patient compliance with the HIIP delivery system Directions for Use (DFU) |  |  | 
| assess the impact of practice inhalations on inspiratory flow parameters (peak inspiratory flow rate [IFR] and total inspired volume [TIV]) achieved by patients using the insulin inhaler following training with the DFU |  |  |