Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
- Conditions
- Diabetes, Type I
- Interventions
- Drug: Technosphere InsulinDrug: Active comparator
- Registration Number
- NCT00308308
- Lead Sponsor
- Mannkind Corporation
- Brief Summary
To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 589
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Technosphere Insulin Technosphere Insulin 2 Active comparator Rapid-acting analogue insulin plus basal insulin glargine
- Primary Outcome Measures
Name Time Method Compare the Mean Change From Baseline to Week 52 in HbA1c Baseline to Week 52
- Secondary Outcome Measures
Name Time Method Change From Baseline in Weight to Week 52 Baseline to Week 52 Change from baseline in weight at Week 52
Change From Baseline in Fasting Plasma Glucose to Week 52 Baseline to Week 52 Change from baseline in fasting plasma glucose at Week 52
Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0% Baseline to Week 52 Number of subjects achieving week 52 HbA1c levels less than or equal to 7.0%
Incidence of Total Hypoglycemia Baseline to Week 52 Defined as hypoglycemic symptoms that are relieved with carbohydrate intake or blood glucose measurement \<= 63 mg/dL, regardless of symptoms.
Incidence of Severe Hypoglycemia Baseline to Week 52 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.Total Hypoglycemia Event Rate Baseline to Week 52 Number of Hypoglycemic Events/Total Subject Exposure Time (in months)
Severe Hypoglycemia Event Rate Baseline to Week 52 Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)
Trial Locations
- Locations (127)
Coastal Biomedical Research Inc
🇺🇸Santa Monica, California, United States
Laureate Clinical Research Group
🇺🇸Atlanta, Georgia, United States
John H Stoger Jr Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Radiant Research Dallas-North
🇺🇸Dallas, Texas, United States
Endocrine Research - Physician's East PA
🇺🇸Greenville, North Carolina, United States
Baylor Endocrine Center
🇺🇸Dallas, Texas, United States
International Research Associates LLC
🇺🇸Miami, Florida, United States
Cedar Research
🇺🇸Tacoma, Washington, United States
Radiant Research (Phoenix)
🇺🇸Chandler, Arizona, United States
Coastal Clinical Research Inc
🇺🇸Mobile, Alabama, United States
International Clinical Research Network
🇺🇸Chula Vista, California, United States
Family Medical Center
🇺🇸Foothill Ranch, California, United States
South Bay Clinical Research
🇺🇸Inglewood, California, United States
Diabetes/Lipid Management and Research Center
🇺🇸Huntington Beach, California, United States
Diabetes Research Center
🇺🇸Tustin, California, United States
Atlanta Pharmaceutical Research Center
🇺🇸Dunwoody, Georgia, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
North Atlanta Endocrinology & Diabetes PC
🇺🇸Lawrenceville, Georgia, United States
Clintell Inc
🇺🇸Skokie, Illinois, United States
Medical Research of Louisiana
🇺🇸Metairie, Louisiana, United States
Michigan Institute of Medicine
🇺🇸Livonia, Michigan, United States
Oschner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
James A Dicke MDPA
🇺🇸Towson, Maryland, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Radiant Research Inc (Minneapolis)
🇺🇸Edina, Minnesota, United States
Healthcare Research
🇺🇸Florissant, Missouri, United States
KMED Research
🇺🇸St Clair Shores, Michigan, United States
MedEx Healthcare Research Inc(009)
🇺🇸St Louis, Missouri, United States
Amin Radparvar's Private Practice
🇺🇸St Peters, Missouri, United States
University of Physicians Group Endocrine Division
🇺🇸Staten Island, New York, United States
Billings Clinic Research Division
🇺🇸Billings, Montana, 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
Creighton Diabetes Center
🇺🇸Omaha, Nebraska, United States
Legacy Clinical Research
🇺🇸Portland, Oregon, United States
Providence Health Partners - Center of Clinical Research
🇺🇸Dayton, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Covance CRU Inc.
🇺🇸Portland, Oregon, United States
Portland Diabetes & Endocrinology Center
🇺🇸Portland, Oregon, United States
AM Diabetes and Endocrinology Center
🇺🇸Bartlett, Tennessee, United States
Southeastern Research Associates Inc
🇺🇸Williamston, South Carolina, United States
Pennsylvania Research Institute
🇺🇸Bensalem, Pennsylvania, United States
Israel Hartman MD
🇺🇸Arlington, Texas, United States
Dallas Diabetes & Endocrine Center
🇺🇸Dallas, Texas, United States
The Endocrine Clinic
🇺🇸Memphis, Tennessee, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Spuhler Medical Associates
🇺🇸Friendswood, Texas, United States
Edward Bali MD PA
🇺🇸Seguin, Texas, United States
Sentara Medical Group
🇺🇸Virginia Beach, Virginia, United States
Larry D Stonesifer MD Inc PS
🇺🇸Federal Way, Washington, United States
Hospital Interzonal de Agudos Pedro Fiorito
🇦🇷Avellaneda, Buenos Aires, Argentina
Centro Endocrinologic Tiempo
🇦🇷Buenos Aires, Argentina
Liberty Research Center
🇺🇸Tacoma, Washington, United States
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Cons Asoc de Endocrinologia
🇦🇷Buenos Aires, Argentina
Hospital Durand /Buenos Aires
🇦🇷Buenos Aires, Argentina
Hospital Gral De Agudos Dr. Teodoro Alvarez
🇦🇷Buenos Aires, Argentina
Centro Medico Dra De Salvo
🇦🇷Buenos Aires, Argentina
CIMeL
🇦🇷Buenos Aires, Argentina
Instituto Estadual De Diabetes e Endocrinologia Luis Capriglione
🇧🇷Rio de Janeiro, Brazil
Universidade Estabual de Maringa
🇧🇷Maringa Parana, Brazil
Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda
🇧🇷Rio de Janeiro, Brazil
Nucleo de Medicina Integrada
🇧🇷Mogi das Cruzes, Brazil
CPClin-Centro de Pesquisas Clinicas
🇧🇷Sao Paulo, Brazil
Blumenau Servicos Medicos S/C Ltda
🇧🇷Sao Paulo, Brazil
Hospital Guilherme Alvaro
🇧🇷Santos, Brazil
Centro de Diabetes/UNIFESP-EPM
🇧🇷Sao Paulo, Brazil
Instituto de Pesquisa Clinica e Medicina Avancada
🇧🇷Sao Paulo, Brazil
Instituto de Informacion de Tramiento y Educacion en Salud
🇨🇱Santiago, Chile
Lifestyle Metabolism Center
🇨🇦Toronto, Ontario, Canada
Hospital del Salvador
🇨🇱Santiago, Region Metropolitana, Chile
Windsor Professional Research
🇨🇦Windsor, Ontario, Canada
Hospital San Jose
🇨🇱Santiago, Chile
Hospital Clinico Pontificia Universidad (009)Catolica de Chile
🇨🇱Santiago, Chile
Hospital San Borja ArriaranUniversidad de Chile
🇨🇱Santiago, Chile
Hospital Padre Alberto Hurtado
🇨🇱Santiago, Chile
Instituto Mexicano de Investigacion
🇲🇽Mexico City, Durango, Mexico
Hospital Santa Engracia-CIMA
🇲🇽Garza Garcia, Mexico
Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio
🇲🇽Mexico City, Mexico
Centro de Estudios en Diabetes
🇲🇽Mexico City, Mexico
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
🇵🇱Bialystok, POL, Poland
Hospital OCA-MIRC (009)
🇲🇽Monterrey, Mexico
Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego
🇵🇱Krakow, POL, Poland
Szpital Kolejowy im Dr w Roeflera(009) Oddzial Gastorenterologii
🇵🇱Pruszkow, POL, Poland
Instytut Centrum Zdrowia (009) Matki Polki
🇵🇱Lodz, POL, Poland
Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego
🇵🇱Lodz, Poland
Oddzial Chorob Wewnetrznych (009 Endokrynologii I Diabetologii Szpitala Wojewodzkiego
🇵🇱Bialystok, Poland
NZOZ Diabetologiczna Poradnia Specjalistyczna
🇵🇱Warszawa, Poland
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
🇷🇺Moscow, RUS, Russian Federation
NHI Kemerovo Regional Clinical Hospital
🇷🇺Kemerovo, RUS, Russian Federation
NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
🇷🇺Moscow, RUS, Russian Federation
Moscow City Clinical Hospital # 13
🇷🇺Moscow, RUS, Russian Federation
SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology
🇷🇺Moscow, RUS, Russian Federation
RAAMS Endocrinology and Diabetology Department
🇷🇺Moscow, RUS, Russian Federation
SI Internal Affairs of Moscow- Clinical Hospital
🇷🇺Moscow, RUS, Russian Federation
SIH of Moscow City Clinical Hopsital #81Endocrinology and Diabetology
🇷🇺Moscow, RUS, Russian Federation
Central Medical Sanitary Unit #122
🇷🇺St Petersburg, RUS, Russian Federation
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
🇷🇺St Petersburg, RUS, Russian Federation
Pavlov State Medical Univ of St Petersburg
🇷🇺St Petersburg, RUS, Russian Federation
St Petersburg NHI Municipal Multi-Speciality Hospital # 2
🇷🇺St. Petersburg, RUS, Russian Federation
MHI Clinical Hospital for Emergency Care na NV Soloviev
🇷🇺Yaroslavl, RUS, Russian Federation
MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant
🇷🇺Yaroslavl, RUS, Russian Federation
NHI Yaroslavl Regional Clinical Hospital
🇷🇺Yaroslavl, RUS, Russian Federation
City Clinical Hospital # 61
🇷🇺Moscow, Russian Federation
Russian Scientific Center of Restoration Medicine & Balneology
🇷🇺Moscow, Russian Federation
Complejo Hospitalario Nuestra Senora de Valme
🇪🇸Sevilla, Andalucia, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Complejo Hospitalario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion
🇪🇸Sevilla, Spain
Birchwood Surgery
🇬🇧Letchworth, Herts, United Kingdom
Sandwell General Hospital
🇬🇧Lyndon, West Bromwich, United Kingdom
Lister Hospital
🇬🇧Stevenage, Herts, United Kingdom
Yaxley Group Practice
🇬🇧Peterborough, United Kingdom
Guy's & St Thomas Hospital
🇬🇧London, United Kingdom
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
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Center for Urologic Clinical Trials University of Minnesota
🇺🇸Minneapolis, Minnesota, 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
Radiant Research Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Radiant Research
🇺🇸San Diego, California, United States