Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
Pulmonary Outcomes Within a 2-Year Period in Subjects With Diabetes Mellitus Treated With Technosphere /Insulin or Usual Antidiabetic Treatment and in Subjects Without Abnormalities in Glucose Control.
1 other identifier
interventional
2,053
8 countries
176
Brief Summary
Pulmonary Safety in Diabetics with T/I
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2005
Typical duration for phase_3
176 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
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 28, 2006
CompletedFirst Posted
Study publicly available on registry
March 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
October 16, 2014
CompletedOctober 16, 2014
October 1, 2014
3.3 years
March 28, 2006
July 22, 2014
October 9, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care
Change from Baseline to End of Study in FEV1 by MMRM
Baseline to Month 24
FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care
FEV1 decrease of ≥ 15% from Baseline value at last measurement
Baseline to Month 24
Secondary Outcomes (10)
Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care
Baseline to Month 24
Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM
Baseline to Month 24
Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM
Baseline to Month 24
Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM
Baseline to Month 24
Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement
Baseline to Month 24
- +5 more secondary outcomes
Study Arms (3)
TI Inhalation Powder
EXPERIMENTALTechnosphere® Insulin Inhalation Powder
Usual care
OTHERUsual care
Non-diabetes
NO INTERVENTIONSubjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)
Interventions
Subjects will receive antidiabetes treatment at the discretion of their physicians
Eligibility Criteria
You may qualify if:
- For All Subjects:
- Nonsmoking
- Body mass index \<42 kg/m2
- FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or equal to 80% of predicted at screening,
- No abnormalities in screening pulmonary radiology
- For Subjects with diabetes mellitus:
- Type 1 or type 2 diabetes for at least 2 years
- HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 %
- For Subjects without abnormalities in glucose control:
- No history of diabetes
- Normal results from a formal glucose tolerance test
You may not qualify if:
- History of chronic obstructive pulmonary disease, asthma, or other significant pulmonary disease
- Significant renal, hepatic, or cardiac disease
- Women who are pregnant, lactating, or planning on becoming pregnant
- Subjects who have participated in studies of other investigational drugs within the previous 3 months
- Evidence of severe complications of diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (176)
Southwest Health Ltd Research Division
Phoenix, Arizona, 85016, United States
Lovelace Scientific Resources
Phoenix, Arizona, 85018, United States
Northwest Medical Center
Phoenix, Arizona, 85029, United States
Arizona Center for Clinical Research
Phoenix, Arizona, 85032, United States
Premiere Pharmaceutical Research LLC
Tempe, Arizona, 85282, United States
Canyon Clinical Research
Tucson, Arizona, 85712, United States
Arizona Research Associates
Tuscon, Arizona, 85712, United States
Private Practice
Burlingame, California, 94010, United States
Saint Agnes Medical Center
Fresno, California, 93720, United States
Valley Research
Fresno, California, 93720, United States
(Private Practice)
Garden Grove, California, 92840, United States
Diabetes/Lipid Management Center
Huntington Beach, California, 92648, United States
Interlink Research Institute
Los Alamitos, California, 90720, United States
Diabetes Care Center
Salinas, California, 93901, United States
San Diego Sports Medicine and Family Health Center
San Diego, California, 92120, United States
Dorothy L & James E Frank Diabetes Research Institute
San Mateo, California, 94401, United States
Sansum Medical Research Institute
Santa Barbara, California, 93105, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Kaiser Permanente
Denver, Colorado, 80205, United States
Denver VA Medical Center
Denver, Colorado, 80220, United States
Alliance Medical Group of Greater Waterbury
Middlebury, Connecticut, 06762, United States
New Britain General Hosptal c?o Betsy Keller
New Britain, Connecticut, 06050, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Perimeter Institute for Clinical Research (PICR)
Atlanta, Georgia, 30338, United States
Executive Health and Research Associates Inc
Atlanta, Georgia, 30342, United States
Rockdale Medical Research Associates
Conyers, Georgia, 30094, United States
Private Practice
Decatur, Georgia, 30035-4000, United States
Atlanta Pharmaceutical Research Center
Dunwoody, Georgia, 30338, United States
North Atlanta Endocrinology & Diabetes PC
Lawrenceville, Georgia, 30045, United States
Southeastern Endocrine & Diabetes
Roswell, Georgia, 30076, United States
Fox Valley Clinical Research Center LLC
Aurora, Illinois, 60504, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, 60061, United States
Medical Research of Louisiana
Metairie, Louisiana, 70001, United States
Ochsner Clinic and Foundation
New Orleans, Louisiana, 70121, United States
Health Trends Research LLC
Baltimore, Maryland, 21208-6391, United States
Franklin Square Hospital
Baltimore, Maryland, 21237, United States
MODEL Clinical Research
Towson, Maryland, 21204, United States
East Coast Clinical Research Inc
Haverhill, Massachusetts, 01830, United States
Clinical Research
Waltham, Massachusetts, 02453, United States
Michigan Institute of Medicine
Livonia, Michigan, 48152, United States
PPS Clinical Research / Southwest Medical Center
Chesterfield, Missouri, 63017, United States
Healthcare Research
Florissant, Missouri, 63031, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
MedEx Healthcare Research Inc
St Louis, Missouri, 63117, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Billings Clinic Research Division
Billings, Montana, 59101, United States
Your Doctors Care
Hillsborough, New Jersey, 08844, United States
Hopewell Valley Family Medicine PA
Trenton, New Jersey, 08618, United States
Umdnj-Som
Voorhees Township, New Jersey, 08084, United States
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, 87106, United States
Lovelace Scientific Resources (Albuquerque)
Albuquerque, New Mexico, 87108, United States
Southwest Endocrinology Associates
Albuquerque, New Mexico, 87109, United States
Physicians Associates of Park Place
Brooklyn, New York, 11216, United States
Diabetes Care & Information Center of New York
Flushing, New York, 11365, United States
Eastside Comprehensive Medical Center
New York, New York, 10021, United States
M.E.R.I.
New York, New York, 10023, United States
Physicians Clinical Research Service (PCRS) (SMO)
White Plains, New York, 10604, United States
Metrolina Medical Research
Charlotte, North Carolina, 28209, United States
Endocrine Research - Physician's East PA
Greenville, North Carolina, 27834, United States
Rapid Medical Research Inc
Cleveland, Ohio, 44122, United States
Your Diabetes Endocrine Nutrition Group
Mentor, Ohio, 44060, United States
New Hope Research of Oregon
Portland, Oregon, 97219, United States
Buckingham Family Medicine
Doyleston, Pennsylvania, 18912, United States
Bucks County Clinical Research
Morrisville, Pennsylvania, 19067, United States
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615, United States
Texas Familicare Clinical Research
Colleyville, Texas, 76034, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Houston Medical Research Associates
Houston, Texas, 77030, United States
North Texas Medical Research
Plano, Texas, 75093, United States
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, 78229, United States
Scott & White Hospital and Clinic
Temple, Texas, 76508, United States
McLennan County Medical Education and Research Foundation
Waco, Texas, 76707, United States
Magna Center for Family Medicine
Magna, Utah, 84044, United States
Davis Family Practice
Salt Lake City, Utah, 84041, United States
Radiant Research Salt Lake City
Salt Lake City, Utah, 84107, United States
Southeastern PA Med Inst LLC (SMO)
Salt Lake City, Utah, 84107, United States
Granger Medical Clinic
West Valley City, Utah, 84120, United States
Hampton Roads Center for Clinical Research Inc
Norfolk, Virginia, 23502, United States
Rainier Clinical Research Center Inc
Renton, Washington, 98055, United States
Clinical Research Department Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
Finchlea Medical Group
Brampton, Ontario, L6T 3J1, Canada
Courtice Health Centre
Courtice, Ontario, Ontario, L1E 3C3, Canada
Parkwood Hospital
London, Ontario, N6C 5J1, Canada
Quest Clinical Trials
Markham, Ontario, L6B 1A1, Canada
Sarnia Institute of Clinical Research
Sarnia, Ontario, N7T 4X3, Canada
The London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, N7T 4X3, Canada
Lifestyle Metabolism Center
Thornhill, Ontario, L4J 8L7, Canada
Albany Medical Center
Toronto, Ontario, M4K 1N5, Canada
Lifestyle Metabolism Center (600-118 Eglinton Ave W)
Toronto, Ontario, M4R 2G4, Canada
Manna Research
Toronto, Ontario, M9W 4L6, Canada
Diabetologicka ambulance
Litoměřice, CZE, 41201, Czechia
Surgery of Diabetology
Mělník, CZE, 276 01, Czechia
Diabetologicka a interni ambulance
Ostrava, CZE, 70200, Czechia
Internal Clinic
Ostrava - Poruba, CZE, 708 52, Czechia
Diabetologicka a interni ambulance
Ostrava-Kunčice, CZE, 70702, Czechia
Surgery of Diabetology Petrovice
Prague, CZE, 109 00, Czechia
FN Motol Interni Klinika
Prague, CZE, 150 06, Czechia
Klinika Endocrinologii Diabetologii I
Bialystock, POL, 15-276, Poland
Oddzial Chorob Wewnetrznych
Bialystock, POL, 15-950, Poland
Dzial Badan Klinicznych Malopoiskie
Krakow, POL, 30 510, Poland
Endokrynologiczno Metaboliczne DIAB_ENDO_MET
Krakow, POL, 31-261, Poland
III Oddzial Chorob Wewnetrznych Szpital
Krakow, POL, 31121, Poland
Oddzial Wewnetrzny B
Lodz, POL, 092-003, Poland
Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, POL, 90 153, Poland
Oddzial Diabetologiczny Centrum
Lodz, POL, 93-338, Poland
Spzital Kolejowy imm Wlodzimierza Roeflera
Pruszków, POL, 05-800, Poland
Klinika Medycyny Rodzinnej i Chorob
Warsaw, POL, 00-416, Poland
Katedra i Klinika Gastroentereologii i
Warsaw, POL, 02-097, Poland
Oddzial Chorob Wewnetznych i Diabetologii
Warsaw, POL, 02-507, Poland
ZPZOZ w Otwocku Szpital Miejski
Warsaw, POL, 05-400, Poland
Oddzial Internistyczny Specjalistyczna
Łask, POL, 98-100, Poland
Kemerovo State Medical Academy of Ministry of Health
Kemerovo, RUS, 650061, Russia
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
Russian State Medical University City Hospital # 4
Moscow, RUS, 113093, Russia
NI Endrocrinological Research Centre of RAMS In patient replacing technologies department
Moscow, RUS, 115478, Russia
Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes
Moscow, RUS, 117036, Russia
Russian State Medical University Central Clinical Hospital Russian Science Academy
Moscow, RUS, 117593, Russia
RAAMS Endocrinology and Diabetology Department
Moscow, RUS, 125315, Russia
SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
Moscow, RUS, 127644, Russia
NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky
Moscow, RUS, 129110, Russia
Municipal Clinical Hospital #13
Moscow, RUS, 150062, Russia
Moscow State Medical-Stomatological University City Clinical Hospital # 23
Moscow, RUS, Russia
Ryazan State Medical University na academician IP Pavlov
Ryazan, RUS, 390026, Russia
Krestovsky Island Medical Institute
Saint Petersburg, RUS, 107110, 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
St Petersburg Medical Academy St Elizabeth Hospital
Saint Petersburg, RUS, 195257, Russia
Pavlov State Medical Univ of St Petersburg
Saint Petersburg, RUS, 197022, Russia
NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital
Smolensk, RUS, 214018, Russia
Clinical Pharm Dept of Yaroslavl Clin Hospital
Yaroslavl, RUS, 150003, Russia
MHI Clinical Hospital for Emergency Care na NV Soloviev
Yaroslavl, RUS, 150003, Russia
NHI Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, 150062, Russia
Yaroslavl Regional Clinical Hospital
Yaroslavl, RUS, 150062, Russia
Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD
Moscow, 105077, Russia
Fundacio Sarda Farriol
Barcelona, ESP, 08017, Spain
Fundacion Jimenez Diaz Servicio Endocrinologia y Nutricion
Madrid, ESP, 28040, Spain
Hospital 12 de Octubre Consultas Extremas - Endocrinologia
Madrid, ESP, 28041, Spain
Hospital Universitario de la Paz
Madrid, ESP, 28046, Spain
Unknown Facility
Seville, ESP, 41009, Spain
Hospital Univ Virgen del Rocío Scio Endocrinología Centro de Diagnosticos Pl Baja
Seville, ESP, 41013, Spain
Hospital Clinic I Provincial
Barcelona, 08036, Spain
Bukovinian State Medical University Dept of Clinical Immun
Chernivtcy, UKR, 58022, Ukraine
Dniepropetrovsh State Medical Academy
Dniepropetrovsk, UKR, 49023, Ukraine
Donetsk State Medical University
Donetsk, UKR, 83003, Ukraine
Donetsk State Medical University
Donetsk, UKR, 83009, Ukraine
Railway Clinical Hospital on Donetsk Station
Donetsk, UKR, 83114, Ukraine
V Danilevsky Inst of Endocrinology Pathology
Kharkiv, UKR, 61070, Ukraine
Medical University at Kiev Center of Endocrinology and Metab
Kiev, UKR, 01004, Ukraine
Chair Family Med of National Med University
Kiev, UKR, 04050, Ukraine
Ukr Scientifically Practical Centre of Endocrine Surgery
Kiev, UKR, 2175, Ukraine
Lugansk State Medical University Chair of Hosp Therapy #2
Luhansk, UKR, 91045, Ukraine
Lugansk State Medical University Chair of Therapy #1
Luhansk, UKR, 91045, Ukraine
Chair of Endocrin & Clinical Pharmacology of Lvov State Medical University
Lviv, UKR, 79010, Ukraine
Odessa State Medical University Dept of Gen Practice and Med Rehab
Odesa, UKR, 65009, Ukraine
Odessa Reg. Clinical Hosp Outpatient Department
Odesa, UKR, 65025, Ukraine
Odessa State Med Dept of Family Med and Gen Practice
Odesa, UKR, 65039, Ukraine
Crimean State Medical University Dept of Therapy #1
Simferopol, UKR, 95017, Ukraine
Vinnitsa State Medical University
Vinnitsa, UKR, 21020, Ukraine
Outpatient Clinic of Family Physician "Rusanovka"
Kiev, 02147, Ukraine
Public Institution City Policlinic #20 Odessa
Odesa, 65114, Ukraine
Barnsley Hospital
Barnsley, GBR, S75 2EP, United Kingdom
Kingthorne Group Practice
Doncaster, GBR, DN3 2LX, United Kingdom
Manny Cussins Centre
Leeds, GBR, LS9 7TF, United Kingdom
Royal liverpool University Hospital
Liverpool, GBR, L7 8XP, United Kingdom
Clinical Research Centre The Royal London Hospital
London, GBR, E1 2AT, United Kingdom
Medinova Research Mount Vernon Hospital
Middlesex, GBR, HA6 2RN, United Kingdom
Edith Cavel Hospital Diabetes Centre
Peterborough, GBR, PE3 9GZ, United Kingdom
Northern General Hospital
Sheffield, GBR, S5 7AU, United Kingdom
Woolpit Medical Practice
Suffolk, GBR, IP30 9QU, United Kingdom
West Suffolk Hospital
Suffolk, GBR, IP33 2QZ, United Kingdom
Birmingham Heartland Hospital
West Midlands, GBR, B9 5SS, United Kingdom
Bradford Hospital Dept of Diabetes & Endocrinology
West Yorkshire, GBR, BD9 6RJ, 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 28, 2006
First Posted
March 30, 2006
Study Start
June 1, 2005
Primary Completion
September 1, 2008
Study Completion
October 1, 2008
Last Updated
October 16, 2014
Results First Posted
October 16, 2014
Record last verified: 2014-10