An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial

Study Overview
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Brief Summary
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Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005

Detailed Description
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This is an uncontrolled study without comparator. Subjects were followed up to 4 years on Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, & 2 for 48 mo.

Official Title
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A Four-year, Safety and Tolerability, Open-Label, Follow on Trial Evaluating Technosphere® Insulin in Subjects With Type 2 Diabetes Mellitus.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous completion of PDC-INS-0008 or MKC-TI-005 Subjects must be able to attend all scheduled visits and, in the opinion of the Investigator, be able to complete this safety trial Subjects must be able to understand English or have access to validated primary language trial documents Written informed consent Exclusion Criteria: Drug or alcohol dependency Smokers (subjects are expected to remain non-smokers throughout their participation in this trial) Known hypersensitivity to the trial drug or to drugs of similar chemical structures Anemia (hemoglobin level < 11 g/dL for females or < 12 g/dL for males) Evidence of moderate or greater ketones in urine Women of childbearing potential practicing inadequate birth control. (Adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, Depo-Provera, contraceptive patches or surgical sterilization) Women who are pregnant Clinically significant adverse events that remain unresolved from the previous trial and/or clinically significant abnormal laboratory values which are determined by the Investigator or the MKC Medical Monitor to be unsafe or confounding to continued participation

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group 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 and MedTone™ Inhaler<br>* Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual Rate of Change in FEV1 From Baseline to End of Study |  | Baseline to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual Rate of Change in FVC From Baseline to End of Study |  | Baseline to 48 months | 
| Annual Rate of Change in DLCo From Baseline to End of Study |  | Baseline to 48 months | 
| Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months) | Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months) | Baseline to last measurement on study drug (maximum of 48 months | 
| Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months) | Change from Baseline to last study measurement on treatment (maximum of 48 months) | Baseline to last study measurement on treatment (maximum of 48 months) | 
| Change in Weight in kg From Baseline to End of Study | Baseline to last measurement on study drug (maximum of 48 months) | Baseline to last measurement on study drug (maximum of 48 months) | 
| High Resolution Computerized Tomography Scans of the Chest |  | End of study |