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)

MannKind

Status and phase

Completed

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Technosphere®/Insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01021891

MKC-TI-015

EudraCT Number: 2007-002818-19

Details and patient eligibility

About

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.

Full description

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).

Enrollment

39 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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