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)

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

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