Diabetes, Type 2 Clinical Trial
Official title:
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.
| Verified date | October 2014 |
| Source | Mannkind Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Pulmonary Safety in Diabetics with T/I
| Status | Completed |
| Enrollment | 2053 |
| Est. completion date | October 2008 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Finchlea Medical Group | Brampton | Ontario |
| Canada | Courtice Health Centre | Courtice, Ontario | Ontario |
| Canada | Parkwood Hospital | London | Ontario |
| Canada | Quest Clinical Trials | Markham | Ontario |
| Canada | Sarnia Institute of Clinical Research | Sarnia | Ontario |
| Canada | The London Road Diagnostic Clinic and Medical Centre | Sarnia | Ontario |
| Canada | Lifestyle Metabolism Center | Thornhill | Ontario |
| Canada | Albany Medical Center | Toronto | Ontario |
| Canada | Lifestyle Metabolism Center (600-118 Eglinton Ave W) | Toronto | Ontario |
| Canada | Manna Research | Toronto | Ontario |
| Czech Republic | Diabetologicka ambulance | Litomerice | CZE |
| Czech Republic | Surgery of Diabetology | Melnik | CZE |
| Czech Republic | Internal Clinic | Ostrava - Poruba | CZE |
| Czech Republic | Diabetologicka a interni ambulance | Ostrava 1 | CZE |
| Czech Republic | Diabetologicka a interni ambulance | Ostrava-Kuncice | CZE |
| Czech Republic | Surgery of Diabetology Petrovice | Prague 15 | CZE |
| Czech Republic | FN Motol Interni Klinika | Praha 6 | CZE |
| Poland | Klinika Endocrinologii Diabetologii I | Bialystock | POL |
| Poland | Oddzial Chorob Wewnetrznych | Bialystock | POL |
| Poland | Dzial Badan Klinicznych Malopoiskie | Krakow | POL |
| Poland | Endokrynologiczno Metaboliczne DIAB_ENDO_MET | Krakow | POL |
| Poland | III Oddzial Chorob Wewnetrznych Szpital | Krakow | POL |
| Poland | Oddzial Internistyczny Specjalistyczna | Lask | POL |
| Poland | Klliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi | Lodz | POL |
| Poland | Oddzial Diabetologiczny Centrum | Lodz | POL |
| Poland | Oddzial Wewnetrzny B | Lodz | POL |
| Poland | Spzital Kolejowy imm Wlodzimierza Roeflera | Pruszkow | POL |
| Poland | Katedra i Klinika Gastroentereologii i | Warsaw | POL |
| Poland | Oddzial Chorob Wewnetznych i Diabetologii | Warsaw | POL |
| Poland | ZPZOZ w Otwocku Szpital Miejski | Warsaw | POL |
| Poland | Klinika Medycyny Rodzinnej i Chorob | Warszawa | POL |
| Russian Federation | Kemerovo State Medical Academy of Ministry of Health | Kemerovo | RUS |
| Russian Federation | NHI Kemerovo Regional Clinical Hospital | Kemerovo | RUS |
| Russian Federation | Federal State Institution Pulmonology Research Institute of Federal Agency of HC&SD | Moscow | |
| Russian Federation | Moscow State Medical-Stomatological University City Clinical Hospital # 23 | Moscow | RUS |
| Russian Federation | Municipal Clinical Hospital #13 | Moscow | RUS |
| Russian Federation | NI Endrocrinological Research Centre of RAMS In patient replacing technologies department | Moscow | RUS |
| Russian Federation | NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky | Moscow | RUS |
| Russian Federation | NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense | Moscow | RUS |
| Russian Federation | RAAMS Endocrinology and Diabetology Department | Moscow | RUS |
| Russian Federation | Russian Academy of Medical Sciences National Research Ctr for Endocrinology Institute of Diabetes | Moscow | RUS |
| Russian Federation | Russian State Medical University Central Clinical Hospital Russian Science Academy | Moscow | RUS |
| Russian Federation | Russian State Medical University City Hospital # 4 | Moscow | RUS |
| Russian Federation | SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology | Moscow | RUS |
| Russian Federation | Ryazan State Medical University na academician IP Pavlov | Ryazan | RUS |
| Russian Federation | NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital | Smolensk | RUS |
| Russian Federation | Central Medical Sanitary Unit #122 | St Petersburg | RUS |
| Russian Federation | Krestovsky Island Medical Institute | St Petersburg | RUS |
| Russian Federation | Pavlov State Medical Univ of St Petersburg | St Petersburg | RUS |
| Russian Federation | St Petersburg Medical Academy St Elizabeth Hospital | St Petersburg | RUS |
| Russian Federation | St Petersburg NHI City Polytclinic #77 City Diabetological Center #4 | St Petersburg | RUS |
| Russian Federation | St Petersburg NHI Municipal Multi-Speciality Hospital # 2 | St. Petersburg | RUS |
| Russian Federation | Clinical Pharm Dept of Yaroslavl Clin Hospital | Yaroslavl | RUS |
| Russian Federation | MHI Clinical Hospital for Emergency Care na NV Soloviev | Yaroslavl | RUS |
| Russian Federation | NHI Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS |
| Russian Federation | Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS |
| Spain | Fundacio Sarda Farriol | Barcelona | ESP |
| Spain | Hospital Clinic I Provincial | Barcelona | |
| Spain | Fundacion Jimenez Diaz Servicio Endocrinologia y Nutricion | Madrid | ESP |
| Spain | Hospital 12 de Octubre Consultas Extremas - Endocrinologia | Madrid | ESP |
| Spain | Hospital Universitario de la Paz | Madrid | ESP |
| Spain | Hospital Univ Virgen del Rocío Scio Endocrinología Centro de Diagnosticos Pl Baja | Sevilla | ESP |
| Ukraine | Bukovinian State Medical University Dept of Clinical Immun | Chernivtcy | UKR |
| Ukraine | Dniepropetrovsh State Medical Academy | Dniepropetrovsk | UKR |
| Ukraine | Donetsk State Medical University | Donetsk | UKR |
| Ukraine | Donetsk State Medical University | Donetsk | UKR |
| Ukraine | Railway Clinical Hospital on Donetsk Station | Donetsk | UKR |
| Ukraine | V Danilevsky Inst of Endocrinology Pathology | Kharkiv | UKR |
| Ukraine | Chair Family Med of National Med University | Kiev | UKR |
| Ukraine | Medical University at Kiev Center of Endocrinology and Metab | Kiev | UKR |
| Ukraine | Outpatient Clinic of Family Physician "Rusanovka" | Kiev | |
| Ukraine | Ukr Scientifically Practical Centre of Endocrine Surgery | Kiev | UKR |
| Ukraine | Lugansk State Medical University Chair of Hosp Therapy #2 | Lugansk | UKR |
| Ukraine | Lugansk State Medical University Chair of Therapy #1 | Lugansk | UKR |
| Ukraine | Chair of Endocrin & Clinical Pharmacology of Lvov State Medical University | Lvov | UKR |
| Ukraine | Odessa Reg. Clinical Hosp Outpatient Department | Odessa | UKR |
| Ukraine | Odessa State Med Dept of Family Med and Gen Practice | Odessa | UKR |
| Ukraine | Odessa State Medical University Dept of Gen Practice and Med Rehab | Odessa | UKR |
| Ukraine | Public Institution City Policlinic #20 Odessa | Odessa | |
| Ukraine | Crimean State Medical University Dept of Therapy #1 | Simferopol | UKR |
| Ukraine | Vinnitsa State Medical University | Vinnitsa | UKR |
| United Kingdom | Barnsley Hospital | Barnsley | GBR |
| United Kingdom | Kingthorne Group Practice | Doncaster | GBR |
| United Kingdom | Manny Cussins Centre | Leeds | GBR |
| United Kingdom | Royal liverpool University Hospital | Liverpool | GBR |
| United Kingdom | Clinical Research Centre The Royal London Hospital | London | GBR |
| United Kingdom | Medinova Research Mount Vernon Hospital | Middlesex | GBR |
| United Kingdom | Edith Cavel Hospital Diabetes Centre | Petersborough | GBR |
| United Kingdom | Northern General Hospital | Sheffield | GBR |
| United Kingdom | West Suffolk Hospital | Suffolk | GBR |
| United Kingdom | Woolpit Medical Practice | Suffolk | GBR |
| United Kingdom | Birmingham Heartland Hospital | West Midlands | GBR |
| United Kingdom | Bradford Hospital Dept of Diabetes & Endocrinology | West Yorkshire | GBR |
| United States | Lovelace Scientific Resources (Albuquerque) | Albuquerque | New Mexico |
| United States | New Mexico Clinical Research & Osteoporosis Center | Albuquerque | New Mexico |
| United States | Southwest Endocrinology Associates | Albuquerque | New Mexico |
| United States | Executive Health and Research Associates Inc | Atlanta | Georgia |
| United States | Perimeter Institute for Clinical Research (PICR) | Atlanta | Georgia |
| United States | Fox Valley Clinical Research Center LLC | Aurora | Illinois |
| United States | Franklin Square Hospital | Baltimore | Maryland |
| United States | Health Trends Research LLC | Baltimore | Maryland |
| United States | Billings Clinic Research Division | Billings | Montana |
| United States | Physicians Associates of Park Place | Brooklyn | New York |
| United States | Private Practice | Burlingame | California |
| United States | Metrolina Medical Research | Charlotte | North Carolina |
| United States | PPS Clinical Research / Southwest Medical Center | Chesterfield | Missouri |
| United States | Cedar-Crosse Research Center | Chicago | Illinois |
| United States | Rapid Medical Research Inc | Cleveland | Ohio |
| United States | Texas Familicare Clinical Research | Colleyville | Texas |
| United States | Rockdale Medical Research Associates | Conyers | Georgia |
| United States | Dallas Diabetes & Endocrine Center | Dallas | Texas |
| United States | University of Texas Southwestern Medical Center | Dallas | Texas |
| United States | Private Practice | Decatur | Georgia |
| United States | Denver VA Medical Center | Denver | Colorado |
| United States | Kaiser Permanente | Denver | Colorado |
| United States | Buckingham Family Medicine | Doyleston | Pennsylvania |
| United States | Atlanta Pharmaceutical Research Center | Dunwoody | Georgia |
| United States | Healthcare Research | Florissant | Missouri |
| United States | Diabetes Care & Information Center of New York | Flushing | New York |
| United States | Saint Agnes Medical Center | Fresno | California |
| United States | Valley Research | Fresno | California |
| United States | (Private Practice) | Garden Grove | California |
| United States | Endocrine Research - Physician's East PA | Greenville | North Carolina |
| United States | Upstate Pharmaceutical Research | Greenville | South Carolina |
| United States | East Coast Clinical Research Inc | Haverhill | Massachusetts |
| United States | Your Doctors Care | Hillsborough | New Jersey |
| United States | Houston Medical Research Associates | Houston | Texas |
| United States | Diabetes/Lipid Management Center | Huntington Beach | California |
| United States | North Atlanta Endocrinology & Diabetes PC | Lawrenceville | Georgia |
| United States | Michigan Institute of Medicine | Livonia | Michigan |
| United States | Interlink Research Institute | Los Alamitos | California |
| United States | Magna Center for Family Medicine | Magna | Utah |
| United States | Your Diabetes Endocrine Nutrition Group | Mentor | Ohio |
| United States | Medical Research of Louisiana | Metairie | Louisiana |
| United States | Alliance Medical Group of Greater Waterbury | Middlebury | Connecticut |
| United States | Bucks County Clinical Research | Morrisville | Pennsylvania |
| United States | New Britain General Hosptal c?o Betsy Keller | New Britain | Connecticut |
| United States | Ochsner Clinic and Foundation | New Orleans | Louisiana |
| United States | Eastside Comprehensive Medical Center | New York | New York |
| United States | M.E.R.I. | New York | New York |
| United States | Hampton Roads Center for Clinical Research Inc | Norfolk | Virginia |
| United States | Arizona Center for Clinical Research | Phoenix | Arizona |
| United States | Lovelace Scientific Resources | Phoenix | Arizona |
| United States | Northwest Medical Center | Phoenix | Arizona |
| United States | Southwest Health Ltd Research Division | Phoenix | Arizona |
| United States | North Texas Medical Research | Plano | Texas |
| United States | New Hope Research of Oregon | Portland | Oregon |
| United States | Rainier Clinical Research Center Inc | Renton | Washington |
| United States | Southeastern Endocrine & Diabetes | Roswell | Georgia |
| United States | Diabetes Care Center | Salinas | California |
| United States | Davis Family Practice | Salt Lake City | Utah |
| United States | Radiant Research Salt Lake City | Salt Lake City | Utah |
| United States | Southeastern PA Med Inst LLC (SMO) | Salt Lake City | Utah |
| United States | Diabetes & Glandular Disease Research Assoc PA | San Antonio | Texas |
| United States | San Diego Sports Medicine and Family Health Center | San Diego | California |
| United States | Dorothy L & James E Frank Diabetes Research Institute | San Mateo | California |
| United States | Sansum Medical Research Institute | Santa Barbara | California |
| United States | Encompass Clinical Research | Spring Valley | California |
| United States | MedEx Healthcare Research Inc | St Louis | Missouri |
| United States | Mercy Health Research | St. Louis | Missouri |
| United States | Washington University School of Medicine | St. Louis | Missouri |
| United States | Premiere Pharmaceutical Research LLC | Tempe | Arizona |
| United States | Scott & White Hospital and Clinic | Temple | Texas |
| United States | MODEL Clinical Research | Towson | Maryland |
| United States | Hopewell Valley Family Medicine PA | Trenton | New Jersey |
| United States | Canyon Clinical Research | Tucson | Arizona |
| United States | Arizona Research Associates | Tuscon | Arizona |
| United States | Deerbrook Medical Associates | Vernon Hills | Illinois |
| United States | Umdnj-Som | Voorhees | New Jersey |
| United States | McLennan County Medical Education and Research Foundation | Waco | Texas |
| United States | Clinical Research | Waltham | Massachusetts |
| United States | Chase Medical Research, LLC | Waterbury | Connecticut |
| United States | Clinical Research Department Wenatchee Valley Medical Center | Wenatchee | Washington |
| United States | Granger Medical Clinic | West Valley City | Utah |
| United States | Physicians Clinical Research Service (PCRS) (SMO) | White Plains | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Mannkind Corporation |
United States, Canada, Czech Republic, Poland, Russian Federation, Spain, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Secondary | Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care | Change from Baseline to last measurement(Month 24) in FEV1 | Baseline to Month 24 | Yes |
| Secondary | Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM | Change from Baseline to Month 24 in FVC by MMRM | Baseline to Month 24 | Yes |
| Secondary | Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM | Change from baseline to Month 24 in TLC by MMRM | Baseline to Month 24 | Yes |
| Secondary | Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM | Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM | Baseline to Month 24 | Yes |
| Secondary | Forced Vital Capacity (FVC) Decrease of = 15% From Baseline Value at Last Measurement | FVC Decrease of =15% from Baseline Value at Last Measurement | Baseline to Month 24 | Yes |
| Secondary | Total Lung Capacity (TLC) Decrease of = 15% From Baseline Value at Last Measurement | TLC Decrease of = 15% from Baseline Value at Last Measurement | Baseline to Month 24 | Yes |
| Secondary | Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of = 15% From Baseline Value at Last Measurement | Hemoglobin-corrected DLco decrease of = 15% from baseline value at last measurement | Baseline to Month 24 | Yes |
| Secondary | Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement | Hemoglobin-corrected DLco decrease of >3 ml/min/mmHg from baseline value at last measurement | Baseline to Month 24 | Yes |
| Secondary | Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care | Change from baseline in HbA1c at last measurement | Baseline to Month 24 | No |
| Secondary | Change in Weight From Baseline at Month 24 | Change from baseline in weight at Month 24 | Baseline to Month 24 | No |
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