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)
Completed · Phase 1
Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)
In brief
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.
Key facts
- Study ID
- NCT01021891
- Run by
- Mannkind Corporation
- People needed
- 39
- Starts
- 2006-07-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2013-12-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Diabetes & Glandular Disease Research Assoc PA — San Antonio, Texas, United States
- Medical University Graz — Graz, Graz, Austria
- University Medical Centre Groningen — Zuidlaren, Netherlands
- Medicines Evaluation Unit (MEU) — Manchester, England, United Kingdom
- ICON Development Solutions — Manchester, United Kingdom
Full record on ClinicalTrials.gov
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