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Clinical Trial Details

Trial ID: L4874
Source ID: NCT00308308
Associated Drug: Technosphere Insulin
Title: Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00308308/results
Conditions: Diabetes, Type I
Interventions: DRUG: Technosphere Insulin|DRUG: Active comparator
Outcome Measures: Primary: Compare the Mean Change From Baseline to Week 52 in HbA1c, Baseline to Week 52 | Secondary: Change From Baseline in Weight to Week 52, Change from baseline in weight at Week 52, Baseline to Week 52|Change From Baseline in Fasting Plasma Glucose to Week 52, Change from baseline in fasting plasma glucose at Week 52, Baseline to Week 52|Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%, Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%, Baseline to Week 52|Incidence of Total Hypoglycemia, Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement \<= 63 mg/dL, regardless of symptoms., Baseline to Week 52|Incidence of Severe Hypoglycemia, Severe hypoglycemia occurs when all 3 of the following occur simultaneously: * Subject requires the assistance of another person; * Subject exhibits at least 1 cognitive neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, seizure, loss of consciousness); * Measured BG is ≤ 49 mg/dL (2.7 mmol/L), or, in the absence of a BG measurement, clinical symptoms are reversed by oral carbohydrates, sc glucagon or intravenous glucose administration; OR, * Measured BG is ≤ 36 mg/dL (2.0 mmol/L) with or without symptoms., Baseline to Week 52|Total Hypoglycemia Event Rate, Number of Hypoglycemic Events/Total Subject Exposure Time (in months), Baseline to Week 52|Severe Hypoglycemia Event Rate, Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months), Baseline to Week 52
Sponsor/Collaborators: Sponsor: Mannkind Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 589
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-02
Completion Date: 2008-08
Results First Posted: 2014-10-16
Last Update Posted: 2014-10-16
Locations: Coastal Clinical Research Inc, Mobile, Alabama, 36608, United States|Radiant Research (Phoenix), Chandler, Arizona, 85225, United States|International Clinical Research Network, Chula Vista, California, 91911, United States|Family Medical Center, Foothill Ranch, California, 92610, United States|Diabetes/Lipid Management and Research Center, Huntington Beach, California, 92648, United States|South Bay Clinical Research, Inglewood, California, 90301, United States|Radiant Research, San Diego, California, 92123, United States|Coastal Biomedical Research Inc, Santa Monica, California, 90404, United States|Diabetes Research Center, Tustin, California, 92780, United States|International Research Associates LLC, Miami, Florida, 33156, United States|Laureate Clinical Research Group, Atlanta, Georgia, 30308, United States|Atlanta Pharmaceutical Research Center, Dunwoody, Georgia, 30338, United States|North Atlanta Endocrinology & Diabetes PC, Lawrenceville, Georgia, 30045, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|John H Stoger Jr Hospital of Cook County, Chicago, Illinois, 60612, United States|Clintell Inc, Skokie, Illinois, 60076, United States|Medical Research of Louisiana, Metairie, Louisiana, 70002, United States|Oschner Clinic Foundation, New Orleans, Louisiana, 70121, United States|James A Dicke MDPA, Towson, Maryland, 21204, United States|Wayne State University, Detroit, Michigan, 48201, United States|Hurley Medical Center, Flint, Michigan, 48503, United States|Michigan Institute of Medicine, Livonia, Michigan, 48152, United States|KMED Research, St Clair Shores, Michigan, 48081, United States|Radiant Research Inc (Minneapolis), Edina, Minnesota, 55435, United States|International Diabetes Center, Minneapolis, Minnesota, 55416, United States|Center for Urologic Clinical Trials University of Minnesota, Minneapolis, Minnesota, 55455, United States|Healthcare Research, Florissant, Missouri, 63031, United States|MedEx Healthcare Research Inc(009), St Louis, Missouri, 63117, United States|Amin Radparvar's Private Practice, St Peters, Missouri, 63376, United States|Billings Clinic Research Division, Billings, Montana, 59101, United States|Creighton Diabetes Center, Omaha, Nebraska, 68131, United States|University of New Mexico HCS, Albuquerque, New Mexico, 87131, United States|Winthrop University Hospital, Mineola, New York, 11501, United States|North Shore Diabetes and Endocrine Associates, New Hyde Park, New York, 11042, United States|University of Physicians Group Endocrine Division, Staten Island, New York, 10301, United States|Endocrine Research - Physician's East PA, Greenville, North Carolina, 27834, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Providence Health Partners - Center of Clinical Research, Dayton, Ohio, 45439, United States|Portland Diabetes & Endocrinology Center, Portland, Oregon, 97210, United States|Legacy Clinical Research, Portland, Oregon, 97232, United States|Covance CRU Inc., Portland, Oregon, 97239, United States|Pennsylvania Research Institute, Bensalem, Pennsylvania, 19020, United States|Southeastern Research Associates Inc, Williamston, South Carolina, 29697, United States|AM Diabetes and Endocrinology Center, Bartlett, Tennessee, 38133, United States|The Endocrine Clinic, Memphis, Tennessee, 38119, United States|Israel Hartman MD, Arlington, Texas, 76014, United States|Dallas Diabetes & Endocrine Center, Dallas, Texas, 75230, United States|Radiant Research Dallas-North, Dallas, Texas, 75231, United States|Baylor Endocrine Center, Dallas, Texas, 75246, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States|Spuhler Medical Associates, Friendswood, Texas, 77546, United States|Quality Assurance Research Center (900), San Antonio, Texas, 78205, United States|Diabetes & Glandular Disease Research Assoc PA, San Antonio, Texas, 78229, United States|SAM Clinical Research Center, San Antonio, Texas, 78229, United States|Edward Bali MD PA, Seguin, Texas, 78155, United States|Radiant Research Salt Lake City, Salt Lake City, Utah, 84107, United States|Salt Lake Research, Salt Lake City, Utah, 84107, United States|Sentara Medical Group, Virginia Beach, Virginia, 23462, United States|Larry D Stonesifer MD Inc PS, Federal Way, Washington, 98003, United States|Cedar Research, Tacoma, Washington, 98405, United States|Liberty Research Center, Tacoma, Washington, 98405, United States|Hospital Interzonal de Agudos Pedro Fiorito, Avellaneda, Buenos Aires, B1870ARG, Argentina|Centro Endocrinologic Tiempo, Buenos Aires, C1117ABH, Argentina|Hospital Italiano de Buenos Aires, Buenos Aires, C1181ACH, Argentina|Hospital Durand /Buenos Aires, Buenos Aires, C1405CWB, Argentina|Hospital Gral De Agudos Dr. Teodoro Alvarez, Buenos Aires, C1406FWY, Argentina|Cons Asoc de Endocrinologia, Buenos Aires, C1425AGC, Argentina|Centro Medico Dra De Salvo, Buenos Aires, C1426ABP, Argentina|CIMeL, Buenos Aires, Argentina|Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, 90035-903, Brazil|Hospital Sao Lucas da PUCRS, Porto Alegre, Rio Grande do Sul, 90610-000, Brazil|Universidade Estabual de Maringa, Maringa Parana, 87020-900, Brazil|Nucleo de Medicina Integrada, Mogi das Cruzes, 08780-090, Brazil|Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione, Rio de Janeiro, 20211-340, Brazil|Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda, Rio de Janeiro, 22271-100, Brazil|Hospital Guilherme Alvaro, Santos, 11045-904, Brazil|CPClin-Centro de Pesquisas Clinicas, Sao Paulo, 01244-030, Brazil|Centro de Diabetes/UNIFESP-EPM, Sao Paulo, 04020-041, Brazil|Blumenau Servicos Medicos S/C Ltda, Sao Paulo, 05302-001, Brazil|Instituto de Pesquisa Clinica e Medicina Avancada, Sao Paulo, 05437-010, Brazil|Lifestyle Metabolism Center, Oakville, Ontario, L6H 3P1, Canada|Lifestyle Metabolism Center, Thornhill, Ontario, L4J 8L7, Canada|Lifestyle Metabolism Center, Toronto, Ontario, M4R 2G4, Canada|Windsor Professional Research, Windsor, Ontario, N8X 3V6, Canada|Hospital del Salvador, Santiago, Region Metropolitana, Chile|Hospital San Jose, Santiago, 1196, Chile|Hospital Clinico Pontificia Universidad (009)Catolica de Chile, Santiago, Chile|Hospital Padre Alberto Hurtado, Santiago, Chile|Hospital San Borja ArriaranUniversidad de Chile, Santiago, Chile|Instituto de Informacion de Tramiento y Educacion en Salud, Santiago, Chile|Instituto Mexicano de Investigacion, Mexico City, Durango, 06700, Mexico|Hospital Santa Engracia-CIMA, Garza Garcia, 66260, Mexico|Centro de Estudios en Diabetes, Mexico City, 01120, Mexico|Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio, Mexico City, 06726, Mexico|Hospital OCA-MIRC (009), Monterrey, 64000, Mexico|NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny, Bialystok, POL, 15-435, Poland|Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego, Krakow, POL, 31 501, Poland|Instytut Centrum Zdrowia (009) Matki Polki, Lodz, POL, 93-338, Poland|Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii, Pruszkow, POL, 05 800, Poland|Oddzial Chorob Wewnetrznych (009 Endokrynologii I Diabetologii Szpitala Wojewodzkiego, Bialystok, 15-950, Poland|Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego, Lodz, 90-153, Poland|NZOZ Diabetologiczna Poradnia Specjalistyczna, Warszawa, 01-911, Poland|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|NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70, Moscow, RUS, 111399, Russian Federation|Moscow City Clinical Hospital # 13, Moscow, RUS, 115280, Russian Federation|SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology, Moscow, RUS, 119435, Russian Federation|SI Internal Affairs of Moscow- Clinical Hospital, Moscow, RUS, 125299, Russian Federation|RAAMS Endocrinology and Diabetology Department, Moscow, RUS, 125315, Russian Federation|SIH of Moscow City Clinical Hopsital #81Endocrinology and Diabetology, Moscow, RUS, 127644, 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|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|MHI Clinical Hospital for Emergency Care na NV Soloviev, Yaroslavl, RUS, 150003, Russian Federation|MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant, Yaroslavl, RUS, 150023, Russian Federation|NHI Yaroslavl Regional Clinical Hospital, Yaroslavl, RUS, 150062, Russian Federation|City Clinical Hospital # 61, Moscow, 119 048, Russian Federation|Russian Scientific Center of Restoration Medicine & Balneology, Moscow, 121069, Russian Federation|Complejo Hospitalario Nuestra Senora de Valme, Sevilla, Andalucia, 41014, Spain|Hospital del Mar, Barcelona, 08003, Spain|Hospital Ramon y Cajal, Madrid, 28034, Spain|Complejo Hospitalario Virgen del Rocio, Sevilla, 41013, Spain|Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion, Sevilla, 41071, Spain|Birchwood Surgery, Letchworth, Herts, SG6 4UB, United Kingdom|Lister Hospital, Stevenage, Herts, SG1 4AB, United Kingdom|Sandwell General Hospital, Lyndon, West Bromwich, B71 4HJ, United Kingdom|Guy's & St Thomas Hospital, London, SE1 9RT, United Kingdom|Yaxley Group Practice, Peterborough, PE7 3JL, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00308308

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress