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Clinical Trial Details

Trial ID: L6169
Source ID: NCT00308737
Associated Drug: Technosphere® Insulin Inhalation Powder
Title: Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00308737/results
Conditions: Diabetes, Type 1|Diabetes, Type 2
Interventions: DRUG: Technosphere® Insulin Inhalation Powder|DRUG: Usual Care
Outcome Measures: Primary: Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care, Change from Baseline to End of Study in FEV1 by MMRM, Baseline to Month 24|FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care, FEV1 decrease of ≥ 15% from Baseline value at last measurement, Baseline to Month 24 | Secondary: Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care, Change from Baseline to last measurement(Month 24) in FEV1, Baseline to Month 24|Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM, Change from Baseline to Month 24 in FVC by MMRM, Baseline to Month 24|Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM, Change from baseline to Month 24 in TLC by MMRM, Baseline to Month 24|Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM, Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM, Baseline to Month 24|Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement, FVC Decrease of ≥15% from Baseline Value at Last Measurement, Baseline to Month 24|Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement, TLC Decrease of ≥ 15% from Baseline Value at Last Measurement, Baseline to Month 24|Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement, Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement, Baseline to Month 24|Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement, Hemoglobin-corrected DLco decrease of \>3 ml/min/mmHg from baseline value at last measurement, Baseline to Month 24|Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care, Change from baseline in HbA1c at last measurement, Baseline to Month 24|Change in Weight From Baseline at Month 24, Change from baseline in weight at Month 24, Baseline to Month 24
Sponsor/Collaborators: Sponsor: Mannkind Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 2053
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2005-06
Completion Date: 2008-10
Results First Posted: 2014-10-16
Last Update Posted: 2014-10-16
Locations: Southwest Health Ltd Research Division, Phoenix, Arizona, 85016, United States|Lovelace Scientific Resources, Phoenix, Arizona, 85018, United States|Northwest Medical Center, Phoenix, Arizona, 85029, United States|Arizona Center for Clinical Research, Phoenix, Arizona, 85032, United States|Premiere Pharmaceutical Research LLC, Tempe, Arizona, 85282, United States|Canyon Clinical Research, Tucson, Arizona, 85712, United States|Arizona Research Associates, Tuscon, Arizona, 85712, United States|Private Practice, Burlingame, California, 94010, United States|Saint Agnes Medical Center, Fresno, California, 93720, United States|Valley Research, Fresno, California, 93720, United States|(Private Practice), Garden Grove, California, 92840, United States|Diabetes/Lipid Management Center, Huntington Beach, California, 92648, United States|Interlink Research Institute, Los Alamitos, California, 90720, United States|Diabetes Care Center, Salinas, California, 93901, United States|San Diego Sports Medicine and Family Health Center, San Diego, California, 92120, United States|Dorothy L & James E Frank Diabetes Research Institute, San Mateo, California, 94401, United States|Sansum Medical Research Institute, Santa Barbara, California, 93105, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Kaiser Permanente, Denver, Colorado, 80205, United States|Denver VA Medical Center, Denver, Colorado, 80220, United States|Alliance Medical Group of Greater Waterbury, Middlebury, Connecticut, 06762, United States|New Britain General Hosptal c?o Betsy Keller, New Britain, Connecticut, 06050, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Perimeter Institute for Clinical Research (PICR), Atlanta, Georgia, 30338, United States|Executive Health and Research Associates Inc, Atlanta, Georgia, 30342, United States|Rockdale Medical Research Associates, Conyers, Georgia, 30094, United States|Private Practice, Decatur, Georgia, 30035-4000, United States|Atlanta Pharmaceutical Research Center, Dunwoody, Georgia, 30338, United States|North Atlanta Endocrinology & Diabetes PC, Lawrenceville, Georgia, 30045, United States|Southeastern Endocrine & Diabetes, Roswell, Georgia, 30076, United States|Fox Valley Clinical Research Center LLC, Aurora, Illinois, 60504, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Deerbrook Medical Associates, Vernon Hills, Illinois, 60061, United States|Medical Research of Louisiana, Metairie, Louisiana, 70001, United States|Ochsner Clinic and Foundation, New Orleans, Louisiana, 70121, United States|Health Trends Research LLC, Baltimore, Maryland, 21208-6391, United States|Franklin Square Hospital, Baltimore, Maryland, 21237, United States|MODEL Clinical Research, Towson, Maryland, 21204, United States|East Coast Clinical Research Inc, Haverhill, Massachusetts, 01830, United States|Clinical Research, Waltham, Massachusetts, 02453, United States|Michigan Institute of Medicine, Livonia, Michigan, 48152, United States|PPS Clinical Research / Southwest Medical Center, Chesterfield, Missouri, 63017, United States|Healthcare Research, Florissant, Missouri, 63031, United States|MedEx Healthcare Research Inc, St Louis, Missouri, 63117, United States|Washington University School of Medicine, St. Louis, Missouri, 63110, United States|Mercy Health Research, St. Louis, Missouri, 63141, United States|Billings Clinic Research Division, Billings, Montana, 59101, United States|Your Doctors Care, Hillsborough, New Jersey, 08844, United States|Hopewell Valley Family Medicine PA, Trenton, New Jersey, 08618, United States|Umdnj-Som, Voorhees, New Jersey, 08084, United States|New Mexico Clinical Research & Osteoporosis Center, Albuquerque, New Mexico, 87106, United States|Lovelace Scientific Resources (Albuquerque), Albuquerque, New Mexico, 87108, United States|Southwest Endocrinology Associates, Albuquerque, New Mexico, 87109, United States|Physicians Associates of Park Place, Brooklyn, New York, 11216, United States|Diabetes Care & Information Center of New York, Flushing, New York, 11365, United States|Eastside Comprehensive Medical Center, New York, New York, 10021, United States|M.E.R.I., New York, New York, 10023, United States|Physicians Clinical Research Service (PCRS) (SMO), White Plains, New York, 10604, United States|Metrolina Medical Research, Charlotte, North Carolina, 28209, United States|Endocrine Research - Physician's East PA, Greenville, North Carolina, 27834, United States|Rapid Medical Research Inc, Cleveland, Ohio, 44122, United States|Your Diabetes Endocrine Nutrition Group, Mentor, Ohio, 44060, United States|New Hope Research of Oregon, Portland, Oregon, 97219, United States|Buckingham Family Medicine, Doyleston, Pennsylvania, 18912, United States|Bucks County Clinical Research, Morrisville, Pennsylvania, 19067, United States|Upstate Pharmaceutical Research, Greenville, South Carolina, 29615, United States|Texas Familicare Clinical Research, Colleyville, Texas, 76034, United States|Dallas Diabetes & Endocrine Center, Dallas, Texas, 75230, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States|Houston Medical Research Associates, Houston, Texas, 77030, United States|North Texas Medical Research, Plano, Texas, 75093, United States|Diabetes & Glandular Disease Research Assoc PA, San Antonio, Texas, 78229, United States|Scott & White Hospital and Clinic, Temple, Texas, 76508, United States|McLennan County Medical Education and Research Foundation, Waco, Texas, 76707, United States|Magna Center for Family Medicine, Magna, Utah, 84044, United States|Davis Family Practice, Salt Lake City, Utah, 84041, United States|Radiant Research Salt Lake City, Salt Lake City, Utah, 84107, United States|Southeastern PA Med Inst LLC (SMO), Salt Lake City, Utah, 84107, United States|Granger Medical Clinic, West Valley City, Utah, 84120, United States|Hampton Roads Center for Clinical Research Inc, Norfolk, Virginia, 23502, United States|Rainier Clinical Research Center Inc, Renton, Washington, 98055, United States|Clinical Research Department Wenatchee Valley Medical Center, Wenatchee, Washington, 98801, United States|Finchlea Medical Group, Brampton, Ontario, L6T 3J1, Canada|Courtice Health Centre, Courtice, Ontario, Ontario, L1E 3C3, Canada|Parkwood Hospital, London, Ontario, N6C 5J1, Canada|Quest Clinical Trials, Markham, Ontario, L6B 1A1, Canada|Sarnia Institute of Clinical Research, Sarnia, Ontario, N7T 4X3, Canada|The London Road Diagnostic Clinic and Medical Centre, Sarnia, Ontario, N7T 4X3, Canada|Lifestyle Metabolism Center, Thornhill, Ontario, L4J 8L7, Canada|Albany Medical Center, Toronto, Ontario, M4K 1N5, Canada|Lifestyle Metabolism Center (600-118 Eglinton Ave W), Toronto, Ontario, M4R 2G4, Canada|Manna Research, Toronto, Ontario, M9W 4L6, Canada|Diabetologicka ambulance, Litomerice, CZE, 41201, Czech Republic|Surgery of Diabetology, Melnik, CZE, 276 01, Czech Republic|Internal Clinic, Ostrava - Poruba, CZE, 708 52, Czech Republic|Diabetologicka a interni ambulance, Ostrava 1, CZE, 70200, Czech Republic|Diabetologicka a interni ambulance, Ostrava-Kuncice, CZE, 70702, Czech Republic|Surgery of Diabetology Petrovice, Prague 15, CZE, 109 00, Czech Republic|FN Motol Interni Klinika, Praha 6, CZE, 150 06, Czech Republic|Klinika Endocrinologii Diabetologii I, Bialystock, POL, 15-276, Poland|Oddzial Chorob Wewnetrznych, Bialystock, POL, 15-950, Poland|Dzial Badan Klinicznych Malopoiskie, Krakow, POL, 30 510, Poland|Endokrynologiczno Metaboliczne DIAB_ENDO_MET, Krakow, POL, 31-261, Poland|III Oddzial Chorob Wewnetrznych Szpital, Krakow, POL, 31121, Poland|Oddzial Internistyczny Specjalistyczna, Lask, POL, 98-100, Poland|Oddzial Wewnetrzny B, Lodz, POL, 092-003, Poland|Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi, Lodz, POL, 90 153, Poland|Oddzial Diabetologiczny Centrum, Lodz, POL, 93-338, Poland|Spzital Kolejowy imm Wlodzimierza Roeflera, Pruszkow, POL, 05-800, Poland|Katedra i Klinika Gastroentereologii i, Warsaw, POL, 02-097, Poland|Oddzial Chorob Wewnetznych i Diabetologii, Warsaw, POL, 02-507, Poland|ZPZOZ w Otwocku Szpital Miejski, Warsaw, POL, 05-400, Poland|Klinika Medycyny Rodzinnej i Chorob, Warszawa, POL, 00-416, Poland|Kemerovo State Medical Academy of Ministry of Health, Kemerovo, RUS, 650061, Russian Federation|NHI Kemerovo Regional Clinical Hospital, Kemerovo, RUS, 650061, Russian Federation|NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense, Moscow, RUS, 105229, Russian Federation|Russian State Medical University City Hospital # 4, Moscow, RUS, 113093, Russian Federation|NI Endrocrinological Research Centre of RAMS In patient replacing technologies department, Moscow, RUS, 115478, Russian Federation|Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes, Moscow, RUS, 117036, Russian Federation|Russian State Medical University Central Clinical Hospital Russian Science Academy, Moscow, RUS, 117593, Russian Federation|RAAMS Endocrinology and Diabetology Department, Moscow, RUS, 125315, Russian Federation|SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology, Moscow, RUS, 127644, Russian Federation|NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky, Moscow, RUS, 129110, Russian Federation|Municipal Clinical Hospital #13, Moscow, RUS, 150062, Russian Federation|Moscow State Medical-Stomatological University City Clinical Hospital # 23, Moscow, RUS, Russian Federation|Ryazan State Medical University na academician IP Pavlov, Ryazan, RUS, 390026, Russian Federation|NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital, Smolensk, RUS, 214018, Russian Federation|Krestovsky Island Medical Institute, St Petersburg, RUS, 107110, Russian Federation|St Petersburg NHI City Polytclinic #77 City Diabetological Center #4, St Petersburg, RUS, 193012, Russian Federation|Central Medical Sanitary Unit #122, St Petersburg, RUS, 194291, Russian Federation|St Petersburg Medical Academy St Elizabeth Hospital, St Petersburg, RUS, 195257, Russian Federation|Pavlov State Medical Univ of St Petersburg, St Petersburg, RUS, 197022, Russian Federation|St Petersburg NHI Municipal Multi-Speciality Hospital # 2, St. Petersburg, RUS, 194354, Russian Federation|Clinical Pharm Dept of Yaroslavl Clin Hospital, Yaroslavl, RUS, 150003, Russian Federation|MHI Clinical Hospital for Emergency Care na NV Soloviev, Yaroslavl, RUS, 150003, Russian Federation|NHI Yaroslavl Regional Clinical Hospital, Yaroslavl, RUS, 150062, Russian Federation|Yaroslavl Regional Clinical Hospital, Yaroslavl, RUS, 150062, Russian Federation|Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD, Moscow, 105077, Russian Federation|Fundacio Sarda Farriol, Barcelona, ESP, 08017, Spain|Fundacion Jimenez Diaz Servicio Endocrinologia y Nutricion, Madrid, ESP, 28040, Spain|Hospital 12 de Octubre Consultas Extremas - Endocrinologia, Madrid, ESP, 28041, Spain|Hospital Universitario de la Paz, Madrid, ESP, 28046, Spain|Sevilla, ESP, 41009, Spain|Hospital Univ Virgen del Rocío Scio Endocrinología Centro de Diagnosticos Pl Baja, Sevilla, ESP, 41013, Spain|Hospital Clinic I Provincial, Barcelona, 08036, Spain|Bukovinian State Medical University Dept of Clinical Immun, Chernivtcy, UKR, 58022, Ukraine|Dniepropetrovsh State Medical Academy, Dniepropetrovsk, UKR, 49023, Ukraine|Donetsk State Medical University, Donetsk, UKR, 83003, Ukraine|Donetsk State Medical University, Donetsk, UKR, 83009, Ukraine|Railway Clinical Hospital on Donetsk Station, Donetsk, UKR, 83114, Ukraine|V Danilevsky Inst of Endocrinology Pathology, Kharkiv, UKR, 61070, Ukraine|Medical University at Kiev Center of Endocrinology and Metab, Kiev, UKR, 01004, Ukraine|Chair Family Med of National Med University, Kiev, UKR, 04050, Ukraine|Ukr Scientifically Practical Centre of Endocrine Surgery, Kiev, UKR, 2175, Ukraine|Lugansk State Medical University Chair of Hosp Therapy #2, Lugansk, UKR, 91045, Ukraine|Lugansk State Medical University Chair of Therapy #1, Lugansk, UKR, 91045, Ukraine|Chair of Endocrin & Clinical Pharmacology of Lvov State Medical University, Lvov, UKR, 79010, Ukraine|Odessa State Medical University Dept of Gen Practice and Med Rehab, Odessa, UKR, 65009, Ukraine|Odessa Reg. Clinical Hosp Outpatient Department, Odessa, UKR, 65025, Ukraine|Odessa State Med Dept of Family Med and Gen Practice, Odessa, UKR, 65039, Ukraine|Crimean State Medical University Dept of Therapy #1, Simferopol, UKR, 95017, Ukraine|Vinnitsa State Medical University, Vinnitsa, UKR, 21020, Ukraine|Outpatient Clinic of Family Physician "Rusanovka", Kiev, 02147, Ukraine|Public Institution City Policlinic #20 Odessa, Odessa, 65114, Ukraine|Barnsley Hospital, Barnsley, GBR, S75 2EP, United Kingdom|Kingthorne Group Practice, Doncaster, GBR, DN3 2LX, United Kingdom|Manny Cussins Centre, Leeds, GBR, LS9 7TF, United Kingdom|Royal liverpool University Hospital, Liverpool, GBR, L7 8XP, United Kingdom|Clinical Research Centre The Royal London Hospital, London, GBR, E1 2AT, United Kingdom|Medinova Research Mount Vernon Hospital, Middlesex, GBR, HA6 2RN, United Kingdom|Edith Cavel Hospital Diabetes Centre, Petersborough, GBR, PE3 9GZ, United Kingdom|Northern General Hospital, Sheffield, GBR, S5 7AU, United Kingdom|Woolpit Medical Practice, Suffolk, GBR, IP30 9QU, United Kingdom|West Suffolk Hospital, Suffolk, GBR, IP33 2QZ, United Kingdom|Birmingham Heartland Hospital, West Midlands, GBR, B9 5SS, United Kingdom|Bradford Hospital Dept of Diabetes & Endocrinology, West Yorkshire, GBR, BD9 6RJ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00308737

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress