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Clinical Trial Details

Trial ID: L6273
Source ID: NCT00332488
Associated Drug: Technosphere Insulin
Title: Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00332488/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Technosphere Insulin|DRUG: Metformin & Secretagogues|DRUG: Technosphere Insulin & Metformin
Outcome Measures: Primary: Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue, Baseline to Week 12 | Secondary: Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue, (Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue), Baseline to Week 12|Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment), Week 24
Sponsor/Collaborators: Sponsor: Mannkind Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 547
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2004-12
Completion Date:
Results First Posted: 2014-10-16
Last Update Posted: 2014-10-16
Locations: Radiant Research-Birmingham, Birmingham, Alabama, 35209, United States|Parkway Medical Center, Birmingham, Alabama, 35215, United States|Redpoint Research, Phoenix, Arizona, 85029, United States|Arizona Center for Clinical Research, Phoenix, Arizona, 85032, United States|International Clinical Research Network, Chula Vista, California, 91911, United States|National Jewish Medical & Research Center, Denver, Colorado, 80206, United States|Creekside Endocrine Associates, Denver, Colorado, 80209, United States|Jennifer Hone MD, Denver, Colorado, 80220, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Center for Diabetes & Endocrine Care, Hollywood, Florida, 33021, United States|International Research Associates LLC, Miami, Florida, 33156, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|John H Stoger Jr Hospital of Cook County, Chicago, Illinois, 60612, United States|Clintell Inc, Skokie, Illinois, 60076, United States|James A Dicke MDPA, Towson, Maryland, 21204, United States|East Coast Clinical Research Inc, Haverhill, Massachusetts, 01830, United States|Wayne State University, Detroit, Michigan, 48201, United States|Michigan Institute of Medicine, Livonia, Michigan, 48152, United States|Clayton Medical Research, St Louis, Missouri, 63117, United States|Raidant Research-St Louis, St Louis, Missouri, 63141, United States|Washington University School of Medicine, St. Louis, Missouri, 63110, United States|Creighton Diabetes Center, Omaha, Nebraska, 68131, United States|Lovelace Scientific Resources (Albuquerque), Albuquerque, New Mexico, 87108, 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|Metrolina Internal Medicine, Charlotte, North Carolina, 28204, United States|Charlotte Clinical Research Inc, Charlotte, North Carolina, 28211, United States|Sensenbrenner Primary Care, Charlotte, North Carolina, 28277, United States|Duke Medical Center, Durham, North Carolina, 27710, United States|Dayton Clinical Research, Dayton, Ohio, 45406, United States|Providence Health Partners - Center of Clinical Research, Dayton, Ohio, 45439, United States|Radiant Research, Portland, Oregon, 97239, United States|Upstate Pharmaceutical Research, Greenville, South Carolina, 29615, United States|Collierville Medical Specialists, Collierville, Tennessee, 38017, United States|Memphis Internal Medicine (Kathawala), Memphis, Tennessee, 38119, United States|GoodLife Medical Center PLLC, Memphis, Tennessee, 38120, United States|Baylor Endocrine Center, Dallas, Texas, 75246, United States|Quality Assurance Research Center Inc, San Antonio, Texas, 78205, United States|Clinical Trials of Texas Inc, San Antonio, Texas, 78229, United States|Covenant Clinic Research, San Antonio, Texas, 78229, United States|Diabetes & Glandular Disease Research Assoc PA, San Antonio, Texas, 78229, United States|SAM Clinical Research Center, San Antonio, Texas, 78229, United States|Cedar Research, 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|Cons Asoc de Endocrinologia, Buenos Aires, C1425AGC, 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|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|UNIFRSP, Sao Paulo, 04020-050, Brazil|Hospital do Rim e Hipertensao, Sao Paulo, 04025-011, Brazil|Instituto de Pesquisa Clinica e Medicina Avancada, Sao Paulo, 05437-010, Brazil|Quest Clinical Trials, Markham, Ontario, L6B 1A1, Canada|Lifestyle Metabolism Center, Oakville, Ontario, L6H 3P1, Canada|Lifestyle Metabolism Center, Thornhill, Ontario, L4J 8L7, Canada|Lifestyle Metabolism Center, Toronto, Ontario, M4R 2G4, Canada|Trial Management Group Inc (Henein, Toronto, Ontario, M4T 1N5, Canada|Unimedico Management, Richmond Hill, L4C 9M7, Canada|Hospital Padre Alberto Hurtado, Santiago, Region Metropolitana, Chile|Hospital Clinico Pontificia Universidad Catolica de Chile, Santiago, Chile|Hospital del Salvador, Santiago, Chile|Instituto de Informacion de Tramiento y Educacion en Salud, Santiago, Chile|Diabetologicka a interni ambulance, Ostrava-Kuncice, CZE, 70702, Czech Republic|Institute for Clinical and Exp Medicine, Prague 4, CZE, 140 21, Czech Republic|University Hospital Na Bulovce, Prague 8, CZE, 180 81, Czech Republic|Diabetologicka ambulance (Chmura), Ostrava, 70200, Czech Republic|Interní a diabetologická Outpatient, Ostrava, 70900, Czech Republic|II interni klinika FN Kralovske Vinohrady, Praha 10, 10034, Czech Republic|Endokrinologicky ustav, Praha 1, 11694, Czech Republic|3rd Medical Department General Faculty Hospital, Praha 2, 12801, Czech Republic|Instituto Mexicano de Investigacion, Mexico City, Durango, 06700, Mexico|Hospital Universitario Dr Jose E Gonzalez, Monterrey, Nuevo Leon, 64460, 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|OCA-MIRC, Monterrey, 64020, Mexico|Klinika Endocrinologii Diabetologii I, Bialystock, POL, 15-276, Poland|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|Spzital Kolejowy imm Wlodzimierza Roeflera, Pruszkow, POL, 05-800, Poland|Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego, Lodz, 90-153, Poland|Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED, Warsaw, 03 580, Poland|Centrum Leczenia Chorob cywilizacyjnych, Warszawa, 02 777, 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|NI Endrocrinological Research Centre of RAMS In patient replacing technologies department, Moscow, RUS, 115478, Russian Federation|NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky, Moscow, RUS, 129110, Russian Federation|NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital, Smolensk, RUS, 214018, 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|TUV Medico-Military Academy, St Petersburg, RUS, 198013, 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|NHI Yaroslavl Regional Clinical Hospital, Yaroslavl, RUS, 150062, Russian Federation|NI Central Clinical Hospital of RAS, Moscow, 117 593, Russian Federation|Complejo Hospitalario Nuestra Senora de Valme, Sevilla, Andalucia, 41014, Spain|Hospital Clinic I Provincial, Barcelona, 08036, Spain|Hospital Universitario de la Princessa, Madrid, 28006, Spain|Hospital Ramon y Cajal, Madrid, 28034, Spain|Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia, Sabadell, 08208, Spain|Bukovinian State Medical University Dept of Clinical Immun, Chernivtsy, UKR, 58022, Ukraine|Dniepropetrovsh State Medical Academy, Dniepropetrovsk, UKR, 49023, Ukraine|Donetsk State Medical University, Donetsk, UKR, 83003, Ukraine|Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin), Donetsk, UKR, 83099, Ukraine|Railway Clinical Hospital on Donetsk Station, Donetsk, UKR, 83114, Ukraine|Chair Family Med of National Med University, Kiev, UKR, 04050, Ukraine|Institute of Endocrinology and Metabolism, Kiev, UKR, 04114, Ukraine|Ukr Scientifically Practical Centre of Endocrine Surgery, Kiev, UKR, 2175, 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|Vinnitsa State Medical University, Vinnitsa, UKR, 21010, Ukraine|Outpatient Clinic of Family Physician "Rusanovka", Kiev, 02147, Ukraine|Public Institution City Policlinic #20 Odessa, Odessa, 65114, Ukraine
URL: https://clinicaltrials.gov/show/NCT00332488