Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes

Study Overview
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Brief Summary
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To determine in subjects with Type 1 Diabetes Mellitus: Whether glycemic control can be achieved at least as effectively with a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens differ only by the route of delivery of the short acting insulin. The toleration and safety of inhaled insulin therapy and its effects after 6months, if any, on measures of pulmonary function.

Official Title
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Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin in an Intensive Insulin Regimen for Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Inhaled human insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 Diabetes for more than 1 year 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: 12 Years
Maximum Age: 65 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|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. |  |  |