A Study for Patients With Type 2 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 oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication 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 Once-Daily NPH in Insulin-Naïve Patients With Type 2 Diabetes Mellitus on Oral Agents

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Human Insulin Inhalation Powder
* Drug: Neutral protamine hagedorn insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus for at least 6 months One or more oral antihyperglycemic medications for at least 12 weeks HbA1c equal to or greater than 7.0%, and equal to or less than 10.5% Nonsmokers, have 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 Have a current diagnosis 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: Human Insulin Inhalation Powder<br>* patient specific, inhaled, at meals, 76 weeks<br>* Other names: LY 041001;Drug: Neutral protamine hagedorn insulin<br>* patient specific dose, injected, daily, 76 weeks<br>|
| Experimental: 2<br> | Drug: Human Insulin Inhalation Powder<br>* patient specific, inhaled, at meals, 76 weeks<br>* Other names: LY 041001;Drug: Neutral protamine hagedorn insulin<br>* patient specific dose, injected, daily, 76 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase |  | 24, 48 and 76 weeks after Randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8-point SMBG profiles. |  | 24, 48 and 76 weeks after Randomization | 
| Mean change in HbA1c from baseline to the end. |  | 24, 48 and 76 weeks after Randomization | 
| Mean dosage of both preprandial and basal insulin. |  | 24, 48 and 76 weeks after Randomization | 
| Inhaler reliability. |  | 24, 48 and 76 weeks after Randomization | 
| Patient-reported outcomes questionnaires. |  | 24, 48 and 76 weeks after Randomization |