A 2-Month Safety Follow-Up Trial

Study Overview
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Brief Summary
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The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up.

Detailed Description
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This was a 2-month safety follow-up study of subjects from MannKind protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030. No study medications were administered during this trial. The adverse event data included are for the combined Safety population irrespective of previous treatments in the parent trials.

Official Title
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A 2-Month Safety Follow-up Trial of Subjects From MannKind Protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030

Conditions
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Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Drug: Technosphere Insulin Inhalation Powder
* Drug: Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030) Urine cotinine test of less than or equal to 100 ng/mL Written informed consent Exclusion Criteria: Subjects who started smoking during the 4 week follow-up phase of the parent trial Subjects who began a new inhaled insulin regimen with an investigational drug during the 4 week follow-up phase of the parent trial and/or are participation in another clinical trial Female subjects who are pregnant, lactating or planning on becoming pregnant Subjects with a positive urine drug screening at Visit 1 Female subjects of child-bearing potential not practicing adequate birth control

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ex-TI<br>Ex-Technosphere® Insulin Inhalation Powder (subjects previously received TI Inhalation Powder) | Drug: Technosphere Insulin Inhalation Powder<br>* Subjects previously treated with Technosphere Insulin Inhalation Powder<br>|
| Non Ex-TI<br>Non Ex-Technosphere® Insulin Inhalation Powder (subjects previously received another anti-diabetic medication) | Drug: Comparator<br>* Subjects previously treated with other anti-diabetic medications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 |  | 9 to 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 |  | 9 to 27 months | 
| Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 |  | 9 to 27 months | 
| Change in Hemoglobin Corrected DLco (mL/min/mm Hg) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 |  | 9 to 27 months | 
| Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 |  | 3 Months | 
| Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 |  | 3 Months | 
| Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 |  | 3 Months | 
| Change in Hemoglobin Corrected DLco (mL/min/mmHg) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 |  | 3 Months |