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Clinical Trial Details

Trial ID: L7255
Source ID: NCT00472953
Associated Drug: Inhaled Human Insulin
Title: Safety of Inhaled Human Insulin in Subjects With Diabetes Mellitus and Chronic Obstructive Pulmonary Disease (COPD)
Acronym: iINHALE 8
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2|Chronic Obstructive Pulmonary Disease
Interventions: DRUG: inhaled human insulin|DRUG: insulin aspart
Outcome Measures: Primary: To evaluate pulmonary safety comparing inhaled insulin to subcutaneous injections, After one year | Secondary: Patient Reported Outcomes, After one year|Diabetes control measured by change in HbA1c from baseline, After one year|Preprandial Insulin Doses, After one year
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 38
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-05-15
Completion Date: 2008-03-05
Results First Posted:
Last Update Posted: 2017-03-01
Locations: Novo Nordisk Investigational Site, Buenos Aires, B1636DSU, Argentina|Novo Nordisk Investigational Site, Buenos Aires, C1425AGC, Argentina|Novo Nordisk Investigational Site, Ciudad de Buenos Aires, 1280, Argentina|Novo Nordisk Investigational Site, Chandigarh, Punjab, 160012, India|Novo Nordisk Investigational Site, Vellore, Tamil Nadu, 632004, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700020, India|Novo Nordisk Investigational Site, Hyderabad, 600034, India|Novo Nordisk Investigational Site, Mumbai, 400 067, India|Novo Nordisk Investigational Site, Pune, 411011, India|Novo Nordisk Investigational Site, Bucharest, 020475, Romania|Novo Nordisk Investigational Site, Bucharest, 020992, Romania|Novo Nordisk Investigational Site, Kosice, 04190, Slovakia|Novo Nordisk Investigational Site, Lubochna, 03491, Slovakia|Novo Nordisk Investigational Site, Moldava nad Bodvou, 045 01, Slovakia|Novo Nordisk Investigational Site, Zilina, 01001, Slovakia|Novo Nordisk Investigational Site, Zilina, 01207, Slovakia|Novo Nordisk Investigational Site, Changhua, 500, Taiwan|Novo Nordisk Investigational Site, Chiayi City, 600, Taiwan|Novo Nordisk Investigational Site, Taipei, 231, Taiwan|Novo Nordisk Investigational Site, Bangkok, 10330, Thailand|Novo Nordisk Investigational Site, Bangkok, 10700, Thailand|Novo Nordisk Investigational Site, Erzurum, 25240, Turkey|Novo Nordisk Investigational Site, Gaziantep, 27070, Turkey|Novo Nordisk Investigational Site, Istanbul, 34400, Turkey|Novo Nordisk Investigational Site, Istanbul, 34722, Turkey|Novo Nordisk Investigational Site, Istanbul, 34890, Turkey|Novo Nordisk Investigational Site, Kocaeli, 41380, Turkey
URL: https://clinicaltrials.gov/show/NCT00472953