Clinical trial NCT00308308: Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
Official title: A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Basal and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes, Type I
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2006-03-29
Enrollment: 589
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 1 diabetes for at least 1 year
* 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:

* History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings
* Evidence of severe complications of diabetes
* Aminotransferase and/or alanine aminotransferase \> than 3 times the upper limit of normal

Primary outcomes:
measure: Compare the Mean Change From Baseline to Week 52 in HbA1c
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Change From Baseline in Weight to Week 52
timeFrame: Baseline to Week 52
measure: Change From Baseline in Fasting Plasma Glucose to Week 52
timeFrame: Baseline to Week 52
measure: Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%
timeFrame: Baseline to Week 52
measure: Incidence of Total Hypoglycemia
timeFrame: Baseline to Week 52
measure: Incidence of Severe Hypoglycemia
timeFrame: Baseline to Week 52
measure: Total Hypoglycemia Event Rate
timeFrame: Baseline to Week 52
measure: Severe Hypoglycemia Event Rate
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research Inc
state: Alabama
city: Chandler
country: United States
facility: Radiant Research (Phoenix)
state: Arizona
city: Chula Vista
country: United States
facility: International Clinical Research Network
state: California
city: Foothill Ranch
country: United States
facility: Family Medical Center
state: California
city: Huntington Beach
country: United States
facility: Diabetes/Lipid Management and Research Center
state: California
city: Inglewood
country: United States
facility: South Bay Clinical Research
state: California
city: San Diego
country: United States
facility: Radiant Research
state: California
city: Santa Monica
country: United States
facility: Coastal Biomedical Research Inc
state: California
city: Tustin
country: United States
facility: Diabetes Research Center
state: California
city: Miami
country: United States
facility: International Research Associates LLC
state: Florida
city: Atlanta
country: United States
facility: Laureate Clinical Research Group
state: Georgia
city: Dunwoody
country: United States
facility: Atlanta Pharmaceutical Research Center
state: Georgia
city: Lawrenceville
country: United States
facility: North Atlanta Endocrinology & Diabetes PC
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Chicago
country: United States
facility: John H Stoger Jr Hospital of Cook County
state: Illinois
city: Skokie
country: United States
facility: Clintell Inc
state: Illinois
city: Metairie
country: United States
facility: Medical Research of Louisiana
state: Louisiana
city: New Orleans
country: United States
facility: Oschner Clinic Foundation
state: Louisiana
city: Towson
country: United States
facility: James A Dicke MDPA
state: Maryland
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Livonia
country: United States
facility: Michigan Institute of Medicine
state: Michigan
city: St Clair Shores
country: United States
facility: KMED Research
state: Michigan
city: Edina
country: United States
facility: Radiant Research Inc (Minneapolis)
state: Minnesota
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Minneapolis
country: United States
facility: Center for Urologic Clinical Trials University of Minnesota
state: Minnesota
city: Florissant
country: United States
facility: Healthcare Research
state: Missouri
city: St Louis
country: United States
facility: MedEx Healthcare Research Inc(009)
state: Missouri
city: St Peters
country: United States
facility: Amin Radparvar's Private Practice
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Research Division
state: Montana
city: Omaha
country: United States
facility: Creighton Diabetes Center
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico HCS
state: New Mexico
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New Hyde Park
country: United States
facility: North Shore Diabetes and Endocrine Associates
state: New York
city: Staten Island
country: United States
facility: University of Physicians Group Endocrine Division
state: New York
city: Greenville
country: United States
facility: Endocrine Research - Physician's East PA
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners - Center of Clinical Research
state: Ohio
city: Portland
country: United States
facility: Portland Diabetes & Endocrinology Center
state: Oregon
city: Portland
country: United States
facility: Legacy Clinical Research
state: Oregon
city: Portland
country: United States
facility: Covance CRU Inc.
state: Oregon
city: Bensalem
country: United States
facility: Pennsylvania Research Institute
state: Pennsylvania
city: Williamston
country: United States
facility: Southeastern Research Associates Inc
state: South Carolina
city: Bartlett
country: United States
facility: AM Diabetes and Endocrinology Center
state: Tennessee
city: Memphis
country: United States
facility: The Endocrine Clinic
state: Tennessee
city: Arlington
country: United States
facility: Israel Hartman MD
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes & Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Radiant Research Dallas-North
state: Texas
city: Dallas
country: United States
facility: Baylor Endocrine Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Friendswood
country: United States
facility: Spuhler Medical Associates
state: Texas
city: San Antonio
country: United States
facility: Quality Assurance Research Center (900)
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Assoc PA
state: Texas
city: San Antonio
country: United States
facility: SAM Clinical Research Center
state: Texas
city: Seguin
country: United States
facility: Edward Bali MD PA
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research Salt Lake City
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Virginia Beach
country: United States
facility: Sentara Medical Group
state: Virginia
city: Federal Way
country: United States
facility: Larry D Stonesifer MD Inc PS
state: Washington
city: Tacoma
country: United States
facility: Cedar Research
state: Washington
city: Tacoma
country: United States
facility: Liberty Research Center
state: Washington
city: Avellaneda
country: Argentina
facility: Hospital Interzonal de Agudos Pedro Fiorito
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Endocrinologic Tiempo
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Durand /Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Gral De Agudos Dr. Teodoro Alvarez
city: Buenos Aires
country: Argentina
facility: Cons Asoc de Endocrinologia
city: Buenos Aires
country: Argentina
facility: Centro Medico Dra De Salvo
city: Buenos Aires
country: Argentina
facility: CIMeL
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: Rio Grande do Sul
city: Maringa Parana
country: Brazil
facility: Universidade Estabual de Maringa
city: Mogi das Cruzes
country: Brazil
facility: Nucleo de Medicina Integrada
city: Rio de Janeiro
country: Brazil
facility: Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione
city: Rio de Janeiro
country: Brazil
facility: Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
city: Santos
country: Brazil
facility: Hospital Guilherme Alvaro
city: Sao Paulo
country: Brazil
facility: CPClin-Centro de Pesquisas Clinicas
city: Sao Paulo
country: Brazil
facility: Centro de Diabetes/UNIFESP-EPM
city: Sao Paulo
country: Brazil
facility: Blumenau Servicos Medicos S/C Ltda
city: Sao Paulo
country: Brazil
facility: Instituto de Pesquisa Clinica e Medicina Avancada
city: Oakville
country: Canada
facility: Lifestyle Metabolism Center
state: Ontario
city: Thornhill
country: Canada
facility: Lifestyle Metabolism Center
state: Ontario
city: Toronto
country: Canada
facility: Lifestyle Metabolism Center
state: Ontario
city: Windsor
country: Canada
facility: Windsor Professional Research
state: Ontario
city: Santiago
country: Chile
facility: Hospital del Salvador
state: Region Metropolitana
city: Santiago
country: Chile
facility: Hospital San Jose
city: Santiago
country: Chile
facility: Hospital Clinico Pontificia Universidad (009)Catolica de Chile
city: Santiago
country: Chile
facility: Hospital Padre Alberto Hurtado
city: Santiago
country: Chile
facility: Hospital San Borja ArriaranUniversidad de Chile
city: Santiago
country: Chile
facility: Instituto de Informacion de Tramiento y Educacion en Salud
city: Mexico City
country: Mexico
facility: Instituto Mexicano de Investigacion
state: Durango
city: Garza Garcia
country: Mexico
facility: Hospital Santa Engracia-CIMA
city: Mexico City
country: Mexico
facility: Centro de Estudios en Diabetes
city: Mexico City
country: Mexico
facility: Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio
city: Monterrey
country: Mexico
facility: Hospital OCA-MIRC (009)
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
state: POL
city: Krakow
country: Poland
facility: Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego
state: POL
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia (009) Matki Polki
state: POL
city: Pruszkow
country: Poland
facility: Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii
state: POL
city: Bialystok
country: Poland
facility: Oddzial Chorob Wewnetrznych (009 Endokrynologii I Diabetologii Szpitala Wojewodzkiego
city: Lodz
country: Poland
facility: Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
city: Warszawa
country: Poland
facility: NZOZ Diabetologiczna Poradnia Specjalistyczna
city: Kemerovo
country: Russian Federation
facility: NHI Kemerovo Regional Clinical Hospital
state: RUS
city: Moscow
country: Russian Federation
facility: NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
state: RUS
city: Moscow
country: Russian Federation
facility: NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
state: RUS
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital # 13
state: RUS
city: Moscow
country: Russian Federation
facility: SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology
state: RUS
city: Moscow
country: Russian Federation
facility: SI Internal Affairs of Moscow- Clinical Hospital
state: RUS
city: Moscow
country: Russian Federation
facility: RAAMS Endocrinology and Diabetology Department
state: RUS
city: Moscow
country: Russian Federation
facility: SIH of Moscow City Clinical Hopsital #81Endocrinology and Diabetology
state: RUS
city: St Petersburg
country: Russian Federation
facility: St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
state: RUS
city: St Petersburg
country: Russian Federation
facility: Central Medical Sanitary Unit #122
state: RUS
city: St Petersburg
country: Russian Federation
facility: Pavlov State Medical Univ of St Petersburg
state: RUS
city: St. Petersburg
country: Russian Federation
facility: St Petersburg NHI Municipal Multi-Speciality Hospital # 2
state: RUS
city: Yaroslavl
country: Russian Federation
facility: MHI Clinical Hospital for Emergency Care na NV Soloviev
state: RUS
city: Yaroslavl
country: Russian Federation
facility: MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant
state: RUS
city: Yaroslavl
country: Russian Federation
facility: NHI Yaroslavl Regional Clinical Hospital
state: RUS
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 61
city: Moscow
country: Russian Federation
facility: Russian Scientific Center of Restoration Medicine & Balneology
city: Sevilla
country: Spain
facility: Complejo Hospitalario Nuestra Senora de Valme
state: Andalucia
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Sevilla
country: Spain
facility: Complejo Hospitalario Virgen del Rocio
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion
city: Letchworth
country: United Kingdom
facility: Birchwood Surgery
state: Herts
city: Stevenage
country: United Kingdom
facility: Lister Hospital
state: Herts
city: Lyndon
country: United Kingdom
facility: Sandwell General Hospital
state: West Bromwich
city: London
country: United Kingdom
facility: Guy's & St Thomas Hospital
city: Peterborough
country: United Kingdom
facility: Yaxley Group Practice
Study officials:
References: