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)
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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.
Condition or disease
Chronic Obstructive Pulmonary Disease (COPD)
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).
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 [ Time Frame: 30 days ]
Secondary Outcome Measures :
Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I [ Time Frame: 30 days ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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