A Study to Evaluate Insulin in the Blood After Inhalation of a Dry Powder Insulin Formulation (Called Technosphere®/Insulin) in Non-diabetic Patients With & Without Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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Trial will include 40 subjects and consists of 3 visits: Screening, Treatment and Follow up. A euglycemic clamp procedure and Technosphere®/Insulin (T/I) administration will occur at Visit 2 for both COPD and non COPD subjects.

Detailed Description
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Trial objectives are to evaluate the impact of a defined lung disease (COPD) on pharmacokinetic parameters of insulin and fumaryl diketopiperazine (FDKP) after inhalation of Technosphere®/Insulin (T/I), the investigational medicinal product. 40 non diabetic subjects, 20 COPD and 20 age/gender/BMI-matched non COPD subjects will participate in 3 visits: Visit 1 (screening), Visit 2 (subjects will undergo a euglycemic clamp procedure and be dosed with T/I) and Visit 3 (follow up visit).

Official Title
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A Phase 1b, Single-Dose, Open-Label, Parallel, Controlled Pharmacology Trial of Inhaled Technosphere®/Insulin in Non-Diabetic Subjects With COPD Versus Matched Non-Diabetic Subjects Without COPD.

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Technosphere®/Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects minimum 18 and maximum 70 years of age Body Mass Index (BMI) = 36 kg/m2 Subjects with COPD: Diagnosis of COPD (emphysema and/or chronic bronchitis), smoking history =10 years, chronic cough present intermittently or daily with or without sputum and/or dyspnea upon exertion. Subjects with COPD: Pulmonary Function Tests - FEV1 =50% (NHANES) III Predicted; FEV1/FVC < 70 % (NHANES) III; TLC =80% of Predicted (ITS) and DLco(unc) =50% of Predicted (Miller) Subjects without COPD: PFTs: FEV1 = 70% NHANES III Predicted; TLC =80% of Predicted (ITS) and DLco(unc) =80% of Predicted (Miller) Exclusion Criteria: History of pre-diabetes or diabetes Previous or current treatment with any anti-diabetic drugs Serum creatinine > 2.0 mg/dL in males and > 1.8 mg/dL in females Active smokers defined as having smoked their last cigarette, pipe, and/or cigar without the previous 6 months Previous exposure to any inhaled insulin product or investigational medicines/devices within the previous 30 days prior to entry or participation Clinically significant major organ disease Female subjects of childbearing potential not practicing adequate birth control Subjects with COPD: Significant improvement in pre-to post-bronchodilator spirometry (defined as an increase of 12% AND 200 mL in either FVC or FEV1); Any clinically important pulmonary disease except mild or moderate COPD Subjects without COPD: Any important pulmonary disease confirmed by pulmonary function testing and/or radiologic findings

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Diabetic Subj. w/o COPD<br>Single dose, 30 units | Drug: Technosphere®/Insulin<br> <br> |
| Experimental: Non-Diabetic Subj. with COPD<br>Single dose, 30 units | Drug: Technosphere®/Insulin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetic disposition of serum insulin and serum fumaryl diketopiperazine following dosing with 30 U T/I, as measured via Area Under the Curve serum insulin and AUC 0-480 min serum FDKP |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Technosphere® Insulin Inhalation Powder