Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

Study Overview
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Brief Summary
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Pulmonary Safety in Diabetics with T/I

Official Title
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Pulmonary Outcomes Within a 2-Year Period in Subjects With Diabetes Mellitus Treated With Technosphere /Insulin or Usual Antidiabetic Treatment and in Subjects Without Abnormalities in Glucose Control.

Conditions
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Diabetes, Type 1, Diabetes, Type 2

Intervention / Treatment
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* Drug: Technosphere® Insulin Inhalation Powder
* Drug: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For All Subjects: Nonsmoking Body mass index <42 kg/m2 FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening, No abnormalities in screening pulmonary radiology For Subjects with diabetes mellitus: Type 1 or type 2 diabetes for at least 2 years HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 % For Subjects without abnormalities in glucose control: No history of diabetes Normal results from a formal glucose tolerance test Exclusion Criteria: History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease Significant renal, hepatic, or cardiac disease Women who are pregnant, lactating, or planning on becoming pregnant Subjects who have participated in studies of other investigational drugs within the previous 3 months Evidence of severe complications of diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TI Inhalation Powder<br>Technosphere® Insulin Inhalation Powder | Drug: Technosphere® Insulin Inhalation Powder<br>* Inhalation, 15U/30U<br>|
| Other: Usual care<br>Usual care | Drug: Usual Care<br>* Subjects will receive antidiabetes treatment at the discretion of their physicians<br>|
| No Intervention: Non-diabetes<br>Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care | Change from Baseline to End of Study in FEV1 by MMRM | Baseline to Month 24 | 
| FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care | FEV1 decrease of ≥ 15% from Baseline value at last measurement | Baseline to Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care | Change from Baseline to last measurement(Month 24) in FEV1 | Baseline to Month 24 | 
| Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM | Change from Baseline to Month 24 in FVC by MMRM | Baseline to Month 24 | 
| Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM | Change from baseline to Month 24 in TLC by MMRM | Baseline to Month 24 | 
| Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM | Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM | Baseline to Month 24 | 
| Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement | FVC Decrease of ≥15% from Baseline Value at Last Measurement | Baseline to Month 24 | 
| Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement | TLC Decrease of ≥ 15% from Baseline Value at Last Measurement | Baseline to Month 24 | 
| Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement | Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement | Baseline to Month 24 | 
| Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement | Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement | Baseline to Month 24 | 
| Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care | Change from baseline in HbA1c at last measurement | Baseline to Month 24 | 
| Change in Weight From Baseline at Month 24 | Change from baseline in weight at Month 24 | Baseline to Month 24 |