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.

Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes

Sponsors

Lead sponsor: Mannkind Corporation

Source Mannkind Corporation
Brief Summary

Pulmonary Safety in Diabetics with T/I

Overall Status Completed
Start Date June 2005
Completion Date October 2008
Primary Completion Date September 2008
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care Baseline to Month 24
FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care Baseline to Month 24
Secondary Outcome
Measure Time Frame
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
Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement Baseline to Month 24
Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement Baseline to Month 24
Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement Baseline to Month 24
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care Baseline to Month 24
Change in Weight From Baseline at Month 24 Baseline to Month 24
Enrollment 2053
Condition
Intervention

Intervention type: Drug

Intervention name: Technosphere® Insulin Inhalation Powder

Description: Inhalation, 15U/30U

Arm group label: TI Inhalation Powder

Intervention type: Drug

Intervention name: Usual Care

Description: Subjects will receive antidiabetes treatment at the discretion of their physicians

Arm group label: Usual care

Eligibility

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: Accepts Healthy Volunteers

Location
facility
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
MedEx Healthcare Research Inc | St Louis, Missouri, 63117, United States
Washington University School of Medicine | St. Louis, Missouri, 63110, 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, 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 | Litomerice, CZE, 41201, Czech Republic
Surgery of Diabetology | Melnik, CZE, 276 01, Czech Republic
Internal Clinic | Ostrava - Poruba, CZE, 708 52, Czech Republic
Diabetologicka a interni ambulance | Ostrava 1, CZE, 70200, Czech Republic
Diabetologicka a interni ambulance | Ostrava-Kuncice, CZE, 70702, Czech Republic
Surgery of Diabetology Petrovice | Prague 15, CZE, 109 00, Czech Republic
FN Motol Interni Klinika | Praha 6, CZE, 150 06, Czech Republic
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 Internistyczny Specjalistyczna | Lask, POL, 98-100, 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 | Pruszkow, POL, 05-800, 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
Klinika Medycyny Rodzinnej i Chorob | Warszawa, POL, 00-416, Poland
Kemerovo State Medical Academy of Ministry of Health | Kemerovo, RUS, 650061, Russian Federation
NHI Kemerovo Regional Clinical Hospital | Kemerovo, RUS, 650061, Russian Federation
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense | Moscow, RUS, 105229, Russian Federation
Russian State Medical University City Hospital # 4 | Moscow, RUS, 113093, Russian Federation
NI Endrocrinological Research Centre of RAMS In patient replacing technologies department | Moscow, RUS, 115478, Russian Federation
Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes | Moscow, RUS, 117036, Russian Federation
Russian State Medical University Central Clinical Hospital Russian Science Academy | Moscow, RUS, 117593, Russian Federation
RAAMS Endocrinology and Diabetology Department | Moscow, RUS, 125315, Russian Federation
SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology | Moscow, RUS, 127644, Russian Federation
NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky | Moscow, RUS, 129110, Russian Federation
Municipal Clinical Hospital #13 | Moscow, RUS, 150062, Russian Federation
Moscow State Medical-Stomatological University City Clinical Hospital # 23 | Moscow, RUS, Russian Federation
Ryazan State Medical University na academician IP Pavlov | Ryazan, RUS, 390026, Russian Federation
NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital | Smolensk, RUS, 214018, Russian Federation
Krestovsky Island Medical Institute | St Petersburg, RUS, 107110, Russian Federation
St Petersburg NHI City Polytclinic #77 City Diabetological Center #4 | St Petersburg, RUS, 193012, Russian Federation
Central Medical Sanitary Unit #122 | St Petersburg, RUS, 194291, Russian Federation
St Petersburg Medical Academy St Elizabeth Hospital | St Petersburg, RUS, 195257, Russian Federation
Pavlov State Medical Univ of St Petersburg | St Petersburg, RUS, 197022, Russian Federation
St Petersburg NHI Municipal Multi-Speciality Hospital # 2 | St. Petersburg, RUS, 194354, Russian Federation
Clinical Pharm Dept of Yaroslavl Clin Hospital | Yaroslavl, RUS, 150003, Russian Federation
MHI Clinical Hospital for Emergency Care na NV Soloviev | Yaroslavl, RUS, 150003, Russian Federation
NHI Yaroslavl Regional Clinical Hospital | Yaroslavl, RUS, 150062, Russian Federation
Yaroslavl Regional Clinical Hospital | Yaroslavl, RUS, 150062, Russian Federation
Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD | Moscow, 105077, Russian Federation
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
| Sevilla, ESP, 41009, Spain
Hospital Univ Virgen del Rocío Scio Endocrinología Centro de Diagnosticos Pl Baja | Sevilla, 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 | Lugansk, UKR, 91045, Ukraine
Lugansk State Medical University Chair of Therapy #1 | Lugansk, UKR, 91045, Ukraine
Chair of Endocrin & Clinical Pharmacology of Lvov State Medical University | Lvov, UKR, 79010, Ukraine
Odessa State Medical University Dept of Gen Practice and Med Rehab | Odessa, UKR, 65009, Ukraine
Odessa Reg. Clinical Hosp Outpatient Department | Odessa, UKR, 65025, Ukraine
Odessa State Med Dept of Family Med and Gen Practice | Odessa, 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 | Odessa, 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 | Petersborough, 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
Location Countries

Canada

Czech Republic

Poland

Russian Federation

Spain

Ukraine

United Kingdom

United States

Verification Date

October 2014

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: TI Inhalation Powder

Arm group type: Experimental

Description: Technosphere® Insulin Inhalation Powder

Arm group label: Usual care

Arm group type: Other

Description: Usual care

Arm group label: Non-diabetes

Arm group type: No Intervention

Description: Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov