Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
NCT ID: NCT00308308
Last Updated: 2014-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
589 participants
INTERVENTIONAL
2006-02-28
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Technosphere Insulin
Technosphere Insulin
Inhalation, 15U/30U
2
Rapid-acting analogue insulin plus basal insulin glargine
Active comparator
sc injectable insulin
Interventions
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Technosphere Insulin
Inhalation, 15U/30U
Active comparator
sc injectable insulin
Eligibility Criteria
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Inclusion Criteria
* Nonsmokers for prior 6 months
* BMI less than or equal to 35kg/m2
* HbA1c \> or = 7% and \< or = 11%
* Serum creatinine \< or = 1.8 mg/dL in female subjects and \< or = 2.0 mg/dL in male subjects
* FEV1 \> or = 70% of predicted, DLco \> or = 70% , TLC \> or = 80% predicted
* Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
* Urine cotinine \< or = 100 ng/mL
Exclusion Criteria
* Evidence of severe complications of diabetes
* Aminotransferase and/or alanine aminotransferase \> than 3 times the upper limit of normal
18 Years
80 Years
ALL
Yes
Sponsors
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Mannkind Corporation
INDUSTRY
Responsible Party
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Locations
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Coastal Clinical Research Inc
Mobile, Alabama, United States
Radiant Research (Phoenix)
Chandler, Arizona, United States
International Clinical Research Network
Chula Vista, California, United States
Family Medical Center
Foothill Ranch, California, United States
Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States
South Bay Clinical Research
Inglewood, California, United States
Radiant Research
San Diego, California, United States
Coastal Biomedical Research Inc
Santa Monica, California, United States
Diabetes Research Center
Tustin, California, United States
International Research Associates LLC
Miami, Florida, United States
Laureate Clinical Research Group
Atlanta, Georgia, United States
Atlanta Pharmaceutical Research Center
Dunwoody, Georgia, United States
North Atlanta Endocrinology & Diabetes PC
Lawrenceville, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
John H Stoger Jr Hospital of Cook County
Chicago, Illinois, United States
Clintell Inc
Skokie, Illinois, United States
Medical Research of Louisiana
Metairie, Louisiana, United States
Oschner Clinic Foundation
New Orleans, Louisiana, United States
James A Dicke MDPA
Towson, Maryland, United States
Wayne State University
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Michigan Institute of Medicine
Livonia, Michigan, United States
KMED Research
Saint Clair Shores, Michigan, United States
Radiant Research Inc (Minneapolis)
Edina, Minnesota, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Center for Urologic Clinical Trials University of Minnesota
Minneapolis, Minnesota, United States
Amin Radparvar's Private Practice
City of Saint Peters, Missouri, United States
Healthcare Research
Florissant, Missouri, United States
MedEx Healthcare Research Inc(009)
St Louis, Missouri, United States
Billings Clinic Research Division
Billings, Montana, United States
Creighton Diabetes Center
Omaha, Nebraska, United States
University of New Mexico HCS
Albuquerque, New Mexico, United States
Winthrop University Hospital
Mineola, New York, United States
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, United States
University of Physicians Group Endocrine Division
Staten Island, New York, United States
Endocrine Research - Physician's East PA
Greenville, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Providence Health Partners - Center of Clinical Research
Dayton, Ohio, United States
Portland Diabetes & Endocrinology Center
Portland, Oregon, United States
Legacy Clinical Research
Portland, Oregon, United States
Covance CRU Inc.
Portland, Oregon, United States
Pennsylvania Research Institute
Bensalem, Pennsylvania, United States
Southeastern Research Associates Inc
Williamston, South Carolina, United States
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, United States
The Endocrine Clinic
Memphis, Tennessee, United States
Israel Hartman MD
Arlington, Texas, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
Radiant Research Dallas-North
Dallas, Texas, United States
Baylor Endocrine Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Spuhler Medical Associates
Friendswood, Texas, United States
Quality Assurance Research Center (900)
San Antonio, Texas, United States
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, United States
SAM Clinical Research Center
San Antonio, Texas, United States
Edward Bali MD PA
Seguin, Texas, United States
Radiant Research Salt Lake City
Salt Lake City, Utah, United States
Salt Lake Research
Salt Lake City, Utah, United States
Sentara Medical Group
Virginia Beach, Virginia, United States
Larry D Stonesifer MD Inc PS
Federal Way, Washington, United States
Cedar Research
Tacoma, Washington, United States
Liberty Research Center
Tacoma, Washington, United States
Hospital Interzonal de Agudos Pedro Fiorito
Avellaneda, Buenos Aires, Argentina
Centro Endocrinologic Tiempo
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Hospital Durand /Buenos Aires
Buenos Aires, , Argentina
Hospital Gral De Agudos Dr. Teodoro Alvarez
Buenos Aires, , Argentina
Cons Asoc de Endocrinologia
Buenos Aires, , Argentina
Centro Medico Dra De Salvo
Buenos Aires, , Argentina
CIMeL
Buenos Aires, , Argentina
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
CPClin-Centro de Pesquisas Clinicas
São Paulo, São Paulo, Brazil
Universidade Estabual de Maringa
Maringa Parana, , Brazil
Nucleo de Medicina Integrada
Mogi das Cruzes, , Brazil
Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione
Rio de Janeiro, , Brazil
Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
Rio de Janeiro, , Brazil
Hospital Guilherme Alvaro
Santos, , Brazil
Centro de Diabetes/UNIFESP-EPM
São Paulo, , Brazil
Blumenau Servicos Medicos S/C Ltda
São Paulo, , Brazil
Instituto de Pesquisa Clinica e Medicina Avancada
São Paulo, , Brazil
Lifestyle Metabolism Center
Oakville, Ontario, Canada
Lifestyle Metabolism Center
Thornhill, Ontario, Canada
Lifestyle Metabolism Center
Toronto, Ontario, Canada
Windsor Professional Research
Windsor, Ontario, Canada
Hospital del Salvador
Santiago, Santiago Metropolitan, Chile
Hospital San Jose
Santiago, , 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, Mexico
Hospital Santa Engracia-CIMA
Garza García, , Mexico
Centro de Estudios en Diabetes
Mexico City, , Mexico
Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio
Mexico City, , Mexico
Hospital OCA-MIRC (009)
Monterrey, , Mexico
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, POL, Poland
Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego
Krakow, POL, Poland
Instytut Centrum Zdrowia (009) Matki Polki
Lodz, POL, Poland
Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii
Pruszków, POL, Poland
Oddzial Chorob Wewnetrznych (009 Endokrynologii I Diabetologii Szpitala Wojewodzkiego
Bialystok, , Poland
Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
Lodz, , Poland
NZOZ Diabetologiczna Poradnia Specjalistyczna
Warsaw, , Poland
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, Russia
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
Moscow, RUS, Russia
NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
Moscow, RUS, Russia
Moscow City Clinical Hospital # 13
Moscow, RUS, Russia
SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology
Moscow, RUS, Russia
SI Internal Affairs of Moscow- Clinical Hospital
Moscow, RUS, Russia
RAAMS Endocrinology and Diabetology Department
Moscow, RUS, Russia
SIH of Moscow City Clinical Hopsital #81Endocrinology and Diabetology
Moscow, RUS, Russia
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
Saint Petersburg, RUS, Russia
Central Medical Sanitary Unit #122
Saint Petersburg, RUS, Russia
St Petersburg NHI Municipal Multi-Speciality Hospital # 2
Saint Petersburg, RUS, Russia
Pavlov State Medical Univ of St Petersburg
Saint Petersburg, RUS, Russia
MHI Clinical Hospital for Emergency Care na NV Soloviev
Yaroslavl, RUS, Russia
MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant
Yaroslavl, RUS, Russia
NHI Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, Russia
City Clinical Hospital # 61
Moscow, , Russia
Russian Scientific Center of Restoration Medicine & Balneology
Moscow, , Russia
Complejo Hospitalario Nuestra Senora de Valme
Seville, Andalusia, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Complejo Hospitalario Virgen del Rocio
Seville, , Spain
Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion
Seville, , Spain
Birchwood Surgery
Letchworth Garden City, Herts, United Kingdom
Lister Hospital
Stevenage, Herts, United Kingdom
Sandwell General Hospital
Lyndon, West Bromwich, United Kingdom
Guy's & St Thomas Hospital
London, , United Kingdom
Yaxley Group Practice
Peterborough, , United Kingdom
Countries
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Other Identifiers
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MKC-TI-009
Identifier Type: -
Identifier Source: org_study_id
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