Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes

Study Overview
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Brief Summary
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To determine, in subjects with Type 2 Diabetes Mellitus: Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.

Official Title
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Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Inhaled human insulin (EXUBERA™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 Diabetes Stable insulin regimen of at least 2 injections per day Exclusion Criteria: Any smoking within the last 6 months. Smoking is not permitted at any time during this study. Subjects on insulin pump during 2 months prior to screening. Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Drug: Inhaled human insulin (EXUBERA™)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome is 24 week change in baseline in HbA1c. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoints include the following efficacy assessments: |  |  | 
| Incidence of hypoglycemia |  |  | 
| Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%) |  |  | 
| Change from baseline in fasting lipid profile |  |  | 
| Change from baseline in fasting plasma glucose level |  |  | 
| Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose) |  |  | 
| Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study). |  |  | 
| Change from baseline in body weight |  |  | 
| Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments). |  |  | 
| Patient satisfaction and preference. |  |  |