Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
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
1 other identifier
interventional
589
10 countries
129
Brief Summary
To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2006
129 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
October 16, 2014
CompletedOctober 16, 2014
October 1, 2014
2.4 years
March 27, 2006
July 22, 2014
October 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Compare the Mean Change From Baseline to Week 52 in HbA1c
Baseline to Week 52
Secondary Outcomes (7)
Change From Baseline in Weight to Week 52
Baseline to Week 52
Change From Baseline in Fasting Plasma Glucose to Week 52
Baseline to Week 52
Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0%
Baseline to Week 52
Incidence of Total Hypoglycemia
Baseline to Week 52
Incidence of Severe Hypoglycemia
Baseline to Week 52
- +2 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALTechnosphere Insulin
2
ACTIVE COMPARATORRapid-acting analogue insulin plus basal insulin glargine
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (129)
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
Saint 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
Amin Radparvar's Private Practice
City of Saint Peters, Missouri, 63376, United States
Healthcare Research
Florissant, Missouri, 63031, United States
MedEx Healthcare Research Inc(009)
St Louis, Missouri, 63117, 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
CPClin-Centro de Pesquisas Clinicas
São Paulo, São Paulo, 01244-030, 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
Centro de Diabetes/UNIFESP-EPM
São Paulo, 04020-041, Brazil
Blumenau Servicos Medicos S/C Ltda
São Paulo, 05302-001, Brazil
Instituto de Pesquisa Clinica e Medicina Avancada
São 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, Santiago Metropolitan, 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 García, 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
Pruszków, 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
Warsaw, 01-911, Poland
NHI Kemerovo Regional Clinical Hospital
Kemerovo, RUS, 650061, Russia
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
Moscow, RUS, 105229, Russia
NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
Moscow, RUS, 111399, Russia
Moscow City Clinical Hospital # 13
Moscow, RUS, 115280, Russia
SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology
Moscow, RUS, 119435, Russia
SI Internal Affairs of Moscow- Clinical Hospital
Moscow, RUS, 125299, Russia
RAAMS Endocrinology and Diabetology Department
Moscow, RUS, 125315, Russia
SIH of Moscow City Clinical Hopsital #81Endocrinology and Diabetology
Moscow, RUS, 127644, Russia
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4
Saint Petersburg, RUS, 193012, Russia
Central Medical Sanitary Unit #122
Saint Petersburg, RUS, 194291, Russia
St Petersburg NHI Municipal Multi-Speciality Hospital # 2
Saint Petersburg, RUS, 194354, Russia
Pavlov State Medical Univ of St Petersburg
Saint Petersburg, RUS, 197022, Russia
MHI Clinical Hospital for Emergency Care na NV Soloviev
Yaroslavl, RUS, 150003, Russia
MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant
Yaroslavl, RUS, 150023, Russia
NHI Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, 150062, Russia
City Clinical Hospital # 61
Moscow, 119 048, Russia
Russian Scientific Center of Restoration Medicine & Balneology
Moscow, 121069, Russia
Complejo Hospitalario Nuestra Senora de Valme
Seville, Andalusia, 41014, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Complejo Hospitalario Virgen del Rocio
Seville, 41013, Spain
Hospital Virgen Macarena (policlinico) 2ª planta Servicio de Endocrinologia y Nutricion
Seville, 41071, Spain
Birchwood Surgery
Letchworth Garden City, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- MannKind Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2006
First Posted
March 29, 2006
Study Start
February 1, 2006
Primary Completion
July 1, 2008
Study Completion
August 1, 2008
Last Updated
October 16, 2014
Results First Posted
October 16, 2014
Record last verified: 2014-10