Eveluation of the safety of Technosphere® Insulin Inhalation Powder on Diabetic Subjects with Obstructive Pulmonary Disease

• Conditions: Type 1 or type 2 diabetes mellitus and underlying asthma or COPD.; MedDRA version: 16.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2008-000564-16-DE
• Lead Sponsor: MannKind Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-03
• Last Update Posted: 17 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

Key inclusion criteria include:
• Male and female subjects with clinical diagnoses of type 1 or 2 diabetes mellitus for = 12 months and no change in their antidiabetic regimen for at least 90 days prior to screening
• Body mass index (BMI) of < 39 kg/m2
• HbA1c > 6.5% and = 11.5%
• Urine cotinine level = 100 ng/dL

For subjects diagnosed with asthma:
• Physician diagnosis of asthma with history of any or all of the following: recurrent wheezing, recurrent chest tightness, recurrent difficulty breathing, or cough, particularly worse at nighttime
• Never smoked or former smokers (= 6 months since cessation)
• = 18 years of age
• Prebronchodilator FEV1 = 60% Third National Health and Nutrition Examination Survey (NHANES III) predicted, prebronchodilator total lung capacity (TLC) = 80% predicted Intermountain Thoracic Society (ITS), and prebronchodilator single-breath carbon monoxide diffusing capacity of the lung (DLco) (unc) = 70% predicted (Miller)
• < 30% day-to-day variability in daily morning PEF during the 2-week run-in period
• Significant improvement in pre- to postbronchodilator spirometry (defined as an increase from baseline of = 12% and = 200 mL in FEV1 or forced vital capacity [FVC]) at Screening/Visit 1 or documented significant improvement in pre- to postbronchodilator spirometry (as defined above) within past 12 months in subject’s medical records (This test must be performed only after a short-acting bronchodilator medication(s) is withheld for 6 hours and a long-acting bronchodilator medication(s) is withheld for 24 hours) or a documented positive methacholine challenge test within the past 12 months

For subjects diagnosed with COPD:
• Physician diagnosis of COPD (including emphysema and/or chronic bronchitis), history of dyspnea and/or intermittent or daily chronic cough with or without sputum production, not attributable to any other known cause
• Former smoker (= 6 months since cessation) with smoking history of = 10 pack years
• = 40 years of age
• Postbronchodilator FEV1/FVC ratio < 70%
• Postbronchodilator FEV1 = 50% NHANES III predicted, total lung capacity (TLC) = 80% predicted ITS, and DLco (unc) = 50% predicted (Miller)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 459
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 51

Exclusion Criteria

• History of a pulmonary exacerbation within 8 weeks of Screening/Visit 1 (Week -4)
• Use of systemic corticosteroids or antibiotics for a respiratory illness within 8 weeks of Screening/Visit 1 (Week -4)
• Treatment with supplemental oxygen therapy for a respiratory illness for ? 2 days within the 12 months prior to Screening/Visit 1 (Week -4)
• History of intubation or intensive care unit admission for a respiratory illness within the past 5 years
• Greater than 2 hospitalizations or emergency room (ER) or urgent care visits requiring systemic corticosteroid treatment, or required = 3 courses of systemic corticosteroids in the past 12 months for a respiratory illness
• Clinically significant abnormal chest x-ray (in the opinion of PI or the sub-investigator) at Screening/Visit 1 (Week 4)
• Any other clinically important pulmonary disease (eg, interstitial lung disease, cystic fibrosis, bronchiectasis, etc) confirmed by pulmonary function tests (PFTs) and/or radiological findings
• Inability to perform pulmonary function testing that meets American Thoracic Society/European Respiratory Society (ATS/ERS) quality recommendations for acceptability or repeatability
• Respiratory tract infection within 30 days prior to screening (subject may return 30 days after resolution of the infection for re-screening). If a subject has symptoms of a respiratory tract infection upon arrival at the clinical site for Baseline/Visit 2, the subject should be rescheduled for Visit 2, 30 days after the resolution of respiratory tract infection symptoms
• Requires significant change (defined as initiation of a new medication or change in the dose or frequency of the controller medication) in the asthma or COPD therapeutic regimen within 8 weeks of Screening/Visit 1 or between Visit 1 and Baseline/Visit 2
• Known allergy to insulin or any of the drugs to be used in the clinical trial
• Serum creatinine > 2.0 mg/dL (176.80 mmol/L) in males and > 1.8 mg/dL (159.12 mmol/L) in females. In subjects taking metformin, serum creatinine > 1.5 mg/dL (132.60 mmol/L) in males and > 1.4 mg/dL (123.8 mmol/L) in females
• Evidence of serious complications of diabetes mellitus (eg, symptomatic autonomic neuropathy, advanced nephropathy, active proliferative retinopathy, severe peripheral vasculopathy)
• Females who are pregnant or lactating or who plan to become pregnant during the clinical trial period
• Exposure to any investigational product(s) in the past 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified