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)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Technosphere®/Insulin
- Registration Number
- NCT01021891
- Lead Sponsor
- Mannkind Corporation
- Brief 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.
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-Diabetic Subj. w/o COPD Technosphere®/Insulin Single dose, 30 units Non-Diabetic Subj. with COPD Technosphere®/Insulin Single dose, 30 units
- Primary Outcome Measures
Name Time Method 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
Name Time Method Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I 30 days
Trial Locations
- Locations (5)
Diabetes & Glandular Disease Research Assoc PA
🇺🇸San Antonio, Texas, United States
Medicines Evaluation Unit (MEU)
🇬🇧Manchester, England, United Kingdom
ICON Development Solutions
🇬🇧Manchester, United Kingdom
Medical University Graz
🇦🇹Graz, Austria
University Medical Centre Groningen
🇳🇱Zuidlaren, Netherlands