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The main purpose of the trial is to evaluate pulmonary function in subjects who had completed any one of the 4 MKC parent trials (MKC-TI-009, MKC-TI-102, MKC-TI-103, or MKC-TI-030) for an additional 2-month safety follow-up.
This was a 2-month safety follow-up study of subjects from MannKind protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030. No study medications were administered during this trial. The adverse event data included are for the combined Safety population irrespective of previous treatments in the parent trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ex-TI | Ex-Technosphere® Insulin Inhalation Powder (subjects previously received TI Inhalation Powder) |
| |
| Non Ex-TI | Non Ex-Technosphere® Insulin Inhalation Powder (subjects previously received another anti-diabetic medication) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technosphere Insulin Inhalation Powder | Drug | Subjects previously treated with Technosphere Insulin Inhalation Powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 | 9 to 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 | 9 to 27 months | |
| Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 | 9 to 27 months | |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of eligible type 1 and type 2 diabetic subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | United States | ||
| Coastal Clinical Research Inc |
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| Comparator | Drug | Subjects previously treated with other anti-diabetic medications |
|
| Change in Hemoglobin Corrected DLco (mL/min/mm Hg) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 |
| 9 to 27 months |
| Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 | 3 Months |
| Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 | 3 Months |
| Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 | 3 Months |
| Change in Hemoglobin Corrected DLco (mL/min/mmHg) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 | 3 Months |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Radiant Research (Phoenix) | Chandler | Arizona | 85225 | United States |
| Southwest Health Ltd Research Division | Phoenix | Arizona | 85016 | United States |
| Northwest Medical Center | Phoenix | Arizona | 85029 | 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 |
| International Clinical Research Network | Chula Vista | California | 91911 | United States |
| Family Medical Center | Foothill Ranch | California | 92610 | United States |
| Saad Hijazi MD Inc | Fresno | California | 93710 | United States |
| Saint Agnes Medical Center | Fresno | California | 93720 | United States |
| Valley Research | Fresno | California | 93720 | United States |
| Digestive & Liver Disease Specialist A Medical Group Inc | Garden Grove | California | 92840 | United States |
| Diabetes/Lipid Management and Research Center | Huntington Beach | California | 92648 | United States |
| Interlink Research Institute | Los Alamitos | California | 90720 | United States |
| Southern California Endocrine Center | Pasadena | California | 91105 | 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 |
| Coastal Biomedical Research Inc | Santa Monica | California | 90404 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Diabetes Research Center | Tustin | California | 92780 | United States |
| Creekside Endocrine Associates | Denver | Colorado | 80209 | United States |
| Chase Medical Research LLC | Waterbury | Connecticut | 06708 | United States |
| Center for Diabetes & Endocrine Care | Hollywood | Florida | 33021 | United States |
| University of Miami Diabetes Research Institute | Miami | Florida | 33136 | United States |
| International Research Associates LLC | Miami | Florida | 33156 | United States |
| Laureate Clinical Research Group | Atlanta | Georgia | 30308 | 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 | 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 |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | United States |
| John H Stoger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| MODEL Clinical Research | Baltimore | Maryland | 21204 | United States |
| Health Trends Research LLC | Baltimore | Maryland | 21209 | United States |
| Franklin Square Hospital | Baltimore | Maryland | 21237 | United States |
| James A Dicke MDPA | Towson | Maryland | 21204 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| KMED Research | Saint Clair Shores | Michigan | 48081 | United States |
| Radiant Research Inc (Minneapolis) | Edina | Minnesota | 55435 | 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 |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Clayton Medical Research | St Louis | Missouri | 63117 | United States |
| MedEx Healthcare Research Inc(009) | St Louis | Missouri | 63117 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Deaconess Billings Clinic Research Center | Billings | Montana | 59101 | United States |
| Montana Health Research Institute | Billings | Montana | 59102 | United States |
| Creighton Diabetes Center | Omaha | Nebraska | 68131 | United States |
| Your Doctors Care | Hillsborough | New Jersey | 08844 | United States |
| Hopewell Valley Medical Group | Trenton | New Jersey | 08618 | United States |
| Umdnj-Som | Voorhees Township | New Jersey | 08043 | 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 |
| University of New Mexico HCS | Albuquerque | New Mexico | 87131 | United States |
| Diabetes Care & Information Center of New York | Flushing | New York | 11365 | 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 |
| M.E.R.I. | New York | New York | 10023 | United States |
| Univeristy of Physicians Group Endocrine Division | Staten Island | New York | 10301 | United States |
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | United States |
| Sensenbrenner Primary Care | Charlotte | North Carolina | 28277 | United States |
| Physician's East PA | Greenville | North Carolina | 27834 | United States |
| Rapid Medical Research Inc | Cleveland | Ohio | 44122 | United States |
| Providence Health Partners - Center of Clinical Research | Dayton | Ohio | 45439 | United States |
| Wells Institute for Health Awareness | Kettering | Ohio | 45429 | United States |
| Your Diabetes Endocrine Nutrition Group | Mentor | Ohio | 44060 | 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 |
| Bucks County Clinical Research | Morrisville | Pennsylvania | 19067 | United States |
| Upstate Pharmaceutical Research | Greenville | South Carolina | 29615 | United States |
| Southeastern Research Associates Inc | Taylors | South Carolina | 29687 | United States |
| AM Diabetes and Endocrinology Center | Bartlett | Tennessee | 38133 | United States |
| Collierville Medical Specialists | Collierville | Tennessee | 38017 | United States |
| Memphis Internal Medicine PLLC | Memphis | Tennessee | 38119 | United States |
| Israel Hartman MD | Arlington | Texas | 76014 | United States |
| Texas Familicare Clinical Research | Colleyville | Texas | 76034 | United States |
| Dallas Diabetes & Endocrine Center | Dallas | Texas | 75230 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| Radiant Research Dallas-North | Dallas | Texas | 75231 | United States |
| Baylor Endocrine Center | Dallas | Texas | 75246 | United States |
| Galenos Research | Dallas | Texas | 75251 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Spuhler Medical Associates | Friendswood | Texas | 77546 | United States |
| SMO: Pharmaceuticals C-Trials North Texas Medical Research | Plano | Texas | 75093 | United States |
| Quality Assurance Research Center Inc | San Antonio | Texas | 78205 | United States |
| Clinical Trials of Texas Inc | San Antonio | Texas | 78229 | United States |
| Covenant Clinic Research | San Antonio | Texas | 78229 | United States |
| Diabetes & Glandular Disease Research Assoc PA | San Antonio | Texas | 78229 | United States |
| SAM Clinical Research Center | San Antonio | Texas | 78229 | United States |
| Scott & White Hospital and Clinic | Temple | Texas | 76508 | United States |
| Pharmaceutical Research Organization | Bountiful | Utah | 84010 | United States |
| Magna Center for Family Medicine | Magna | Utah | 84044 | United States |
| Radiant Research Salt Lake City | Salt Lake City | Utah | 84107 | United States |
| Salt Lake Research | Salt Lake City | Utah | 84107 | United States |
| Granger Medical Clinic | West Valley City | Utah | 84120 | United States |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | United States |
| Sentara Medical Group | Virginia Beach | Virginia | 23462 | United States |
| Larry D Stonesifer MD Inc PS | Federal Way | Washington | 98003 | United States |
| Rainier Clinical Research Center Inc | Renton | Washington | 98055 | United States |
| Cedar Research | Tacoma | Washington | 98405 | United States |
| Liberty Research Center | Tacoma | Washington | 98405 | United States |
| Wenatchee Valley Medical Center Clinical Research Department | Wenatchee | Washington | 98801 | United States |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| CPClin-Centro de Pesquisas Clinicas | São Paulo | São Paulo | 01244-030 | Brazil |
| Aggarwal and Associates Ltd | Brampton | Ontario | L6T 3J1 | Canada |
| Parkwood Hospital | London | Ontario | N6C 5J1 | Canada |
| Quest Clinical Trials | Markham | Ontario | L6C 1Y9 | Canada |
| Lifestyle Metabolism Center | Oakville | Ontario | L6H 3P1 | 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 |
| Lifestyle Metabolism Center | Toronto | Ontario | M4R 2G4 | Canada |
| Trial Management Group Inc (Henein | Toronto | Ontario | M4T 1N5 | Canada |
| Manna Research | Toronto | Ontario | M9W 4L6 | Canada |
| 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 |
| Moscow State Medical-Stomatological University City Clinical Hospital # 23 | Moscow | RUS | 109240 | Russia |
| NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70 | Moscow | RUS | 111399 | Russia |
| Russian State Medical University City Hospital # 4 | Moscow | RUS | 113093 | Russia |
| Moscow City Clinical Hospital # 13 | Moscow | RUS | 115280 | Russia |
| SHI of Moscow City Clinical Hospital #13 | Moscow | RUS | 115280 | Russia |
| NI Central Clinical Hospital of RAS | Moscow | RUS | 117 593 | Russia |
| Russian State Medical University Central Clinical Hospital Russian Science Academy | Moscow | RUS | 117593 | Russia |
| City Clinical Hospital # 61 | Moscow | RUS | 119048 | Russia |
| SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology | Moscow | RUS | 119435 | Russia |
| Russian Scientific Center of Restoration Medicine & Balneology | Moscow | RUS | 121069 | 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 #81 Endocrinology and Diabetology | Moscow | RUS | 127644 | Russia |
| Ryazan State Medical University na academician IP Pavlov | Ryazan | RUS | 390026 | 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 |
| TUV Medico-Military Academy | Saint Petersburg | RUS | 198013 | 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 |
| MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant | Yaroslavl | RUS | 150023 | Russia |
| NHI Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS | 150062 | Russia |
| Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS | 150062 | Russia |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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