A 2-Month Safety Follow-Up Trial
This study has been completed.
Sponsor:
Mannkind Corporation
Information provided by:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00741429
First received: August 22, 2008
Last updated: October 1, 2009
Last verified: October 2009
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Purpose
The purpose of this trial is to compare pulmonary function and pulmonary adverse events in subjects that participated in four previous MKC parent trials.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A 2-Month Safety Follow-up Trial of Subjects From MannKind Protocols MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030 |
Resource links provided by NLM:
Further study details as provided by Mannkind Corporation:
| Enrollment: | 672 |
| Study Start Date: | May 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Previously received TI
|
|
2
Previously received another anti-diabetic medication
|
Detailed Description:
A 2-month Safety Follow-Up Trial of Subjects from MannKind Protocols, MKC-TI-009, MKC-TI-102, MKC-TI-103 and MKC-TI-030
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The study population consists of eligible type 1 and type 2 diabetic subjects participating in any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030).
Criteria
Inclusion Criteria:
- Subjects who have completed any of the 4 MKC parent trials (MKC-TI-103, MKC-TI-009, MKC-TI-102, MKC-TI-030)
- Urine cotinine test of less than or equal to 100 ng/mL
- Written informed consent
Exclusion Criteria:
- Subjects who started smoking during the 4 week follow-up phase of the parent trial
- Subjects who began a new inhaled insulin regimen with an investigational drug during the 4 week follow-up phase of the parent trial and/or are participation in another clinical trial
- Female subjects who are pregnant, lactating or planning on becoming pregnant
- Subjects with a positive urine drug screening at Visit 1
- Female subjects of child-bearing potential not practicing adequate birth control
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741429
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| United States, Alabama | |
| Parkway Medical Center | |
| Birmingham, Alabama, United States, 35215 | |
| Coastal Clinical Research Inc | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Radiant Research (Phoenix) | |
| Chandler, Arizona, United States, 85225 | |
| Northwest Medical Center | |
| Phoenix, Arizona, United States, 85029 | |
| Southwest Health Ltd Research Division | |
| Phoenix, Arizona, United States, 85016 | |
| Canyon Clinical Research | |
| Tucson, Arizona, United States, 85712 | |
| Arizona Research Associates | |
| Tuscon, Arizona, United States, 85712 | |
| United States, California | |
| Private Practice | |
| Burlingame, California, United States, 94010 | |
| International Clinical Research Network | |
| Chula Vista, California, United States, 91911 | |
| Family Medical Center | |
| Foothill Ranch, California, United States, 92610 | |
| Saint Agnes Medical Center | |
| Fresno, California, United States, 93720 | |
| Valley Research | |
| Fresno, California, United States, 93720 | |
| Saad Hijazi MD Inc | |
| Fresno, California, United States, 93710 | |
| Digestive & Liver Disease Specialist A Medical Group Inc | |
| Garden Grove, California, United States, 92840 | |
| Diabetes/Lipid Management and Research Center | |
| Huntington Beach, California, United States, 92648 | |
| Interlink Research Institute | |
| Los Alamitos, California, United States, 90720 | |
| Southern California Endocrine Center | |
| Pasadena, California, United States, 91105 | |
| Dorothy L & James E Frank Diabetes Research Institute | |
| San Mateo, California, United States, 94401 | |
| Sansum Medical Research Institute | |
| Santa Barbara, California, United States, 93105 | |
| Coastal Biomedical Research Inc | |
| Santa Monica, California, United States, 90404 | |
| Encompass Clinical Research | |
| Spring Valley, California, United States, 91978 | |
| Diabetes Research Center | |
| Tustin, California, United States, 92780 | |
| United States, Colorado | |
| Creekside Endocrine Associates | |
| Denver, Colorado, United States, 80209 | |
| United States, Connecticut | |
| Chase Medical Research LLC | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| Center for Diabetes & Endocrine Care | |
| Hollywood, Florida, United States, 33021 | |
| International Research Associates LLC | |
| Miami, Florida, United States, 33156 | |
| University of Miami Diabetes Research Institute | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Executive Health and Research Associates Inc | |
| Atlanta, Georgia, United States, 30342 | |
| Laureate Clinical Research Group | |
| Atlanta, Georgia, United States, 30308 | |
| Rockdale Medical Research Associates | |
| Conyers, Georgia, United States, 30094 | |
| Private Practice | |
| Decatur, Georgia, United States, 30035 | |
| Atlanta Pharmaceutical Research Center | |
| Dunwoody, Georgia, United States, 30338 | |
| North Atlanta Endocrinology & Diabetes PC | |
| Lawrenceville, Georgia, United States, 30045 | |
| Endocrine Research Solutions, Inc. | |
| Roswell, Georgia, United States, 30076 | |
| United States, Illinois | |
| John H Stoger Jr Hospital of Cook County | |
| Chicago, Illinois, United States, 60612 | |
| Cedar-Crosse Research Center | |
| Chicago, Illinois, United States, 60607 | |
| United States, Maryland | |
| Health Trends Research LLC | |
| Baltimore, Maryland, United States, 21209 | |
| Franklin Square Hospital | |
| Baltimore, Maryland, United States, 21237 | |
| MODEL Clinical Research | |
| Baltimore, Maryland, United States, 21204 | |
| James A Dicke MDPA | |
| Towson, Maryland, United States, 21204 | |
| United States, Michigan | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| KMED Research | |
| St Clair Shores, Michigan, United States, 48081 | |
| United States, Minnesota | |
| Radiant Research Inc (Minneapolis) | |
| Edina, Minnesota, United States, 55435 | |
| Center for Urologic Clinical Trials University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Healthcare Research | |
| Florissant, Missouri, United States, 63031 | |
| Clayton Medical Research | |
| St Louis, Missouri, United States, 63117 | |
| MedEx Healthcare Research Inc(009) | |
| St Louis, Missouri, United States, 63117 | |
| Amin Radparvar's Private Practice | |
| St Peters, Missouri, United States, 63376 | |
| Mercy Health Research | |
| St. Louis, Missouri, United States, 63141 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Montana | |
| Montana Health Research Institute | |
| Billings, Montana, United States, 59102 | |
| Deaconess Billings Clinic Research Center | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Creighton Diabetes Center | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| Your Doctors Care | |
| Hillsborough, New Jersey, United States, 08844 | |
| Hopewell Valley Medical Group | |
| Trenton, New Jersey, United States, 08618 | |
| Umdnj-Som | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New Mexico | |
| New Mexico Clinical Research & Osteoporosis Center | |
| Albuquerque, New Mexico, United States, 87106 | |
| Lovelace Scientific Resources (Albuquerque) | |
| Albuquerque, New Mexico, United States, 87108 | |
| University of New Mexico HCS | |
| Albuquerque, New Mexico, United States, 87131 | |
| Southwest Endocrinology Associates | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Diabetes Care & Information Center of New York | |
| Flushing, New York, United States, 11365 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| North Shore Diabetes and Endocrine Associates | |
| New Hyde Park, New York, United States, 11042 | |
| M.E.R.I. | |
| New York, New York, United States, 10023 | |
| Univeristy of Physicians Group Endocrine Division | |
| Staten Island, New York, United States, 10301 | |
| United States, North Carolina | |
| Sensenbrenner Primary Care | |
| Charlotte, North Carolina, United States, 28277 | |
| Metrolina Medical Research | |
| Charlotte, North Carolina, United States, 28209 | |
| Physician's East PA | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Ohio | |
| Rapid Medical Research Inc | |
| Cleveland, Ohio, United States, 44122 | |
| Providence Health Partners - Center of Clinical Research | |
| Dayton, Ohio, United States, 45439 | |
| Wells Institute for Health Awareness | |
| Kettering, Ohio, United States, 45429 | |
| Your Diabetes Endocrine Nutrition Group | |
| Mentor, Ohio, United States, 44060 | |
| United States, Oregon | |
| Portland Diabetes & Endocrinology Center | |
| Portland, Oregon, United States, 97210 | |
| Legacy Clinical Research | |
| Portland, Oregon, United States, 97232 | |
| Covance CRU Inc. | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Bucks County Clinical Research | |
| Morrisville, Pennsylvania, United States, 19067 | |
| United States, South Carolina | |
| Upstate Pharmaceutical Research | |
| Greenville, South Carolina, United States, 29615 | |
| Southeastern Research Associates Inc | |
| Taylors, South Carolina, United States, 29687 | |
| United States, Tennessee | |
| AM Diabetes and Endocrinology Center | |
| Bartlett, Tennessee, United States, 38133 | |
| Collierville Medical Specialists | |
| Collierville, Tennessee, United States, 38017 | |
| Memphis Internal Medicine PLLC | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Israel Hartman MD | |
| Arlington, Texas, United States, 76014 | |
| Texas Familicare Clinical Research | |
| Colleyville, Texas, United States, 76034 | |
| Radiant Research Dallas-North | |
| Dallas, Texas, United States, 75231 | |
| Galenos Research | |
| Dallas, Texas, United States, 75251 | |
| Baylor Endocrine Center | |
| Dallas, Texas, United States, 75246 | |
| North Texas Endocrine Center | |
| Dallas, Texas, United States, 75231 | |
| Dallas Diabetes & Endocrine Center | |
| Dallas, Texas, United States, 75230 | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Spuhler Medical Associates | |
| Friendswood, Texas, United States, 77546 | |
| SMO: Pharmaceuticals C-Trials North Texas Medical Research | |
| Plano, Texas, United States, 75093 | |
| SAM Clinical Research Center | |
| San Antonio, Texas, United States, 78229 | |
| Diabetes & Glandular Disease Research Assoc PA | |
| San Antonio, Texas, United States, 78229 | |
| Quality Assurance Research Center Inc | |
| San Antonio, Texas, United States, 78205 | |
| Clinical Trials of Texas Inc | |
| San Antonio, Texas, United States, 78229 | |
| Covenant Clinic Research | |
| San Antonio, Texas, United States, 78229 | |
| Scott & White Hospital and Clinic | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Pharmaceutical Research Organization | |
| Bountiful, Utah, United States, 84010 | |
| Magna Center for Family Medicine | |
| Magna, Utah, United States, 84044 | |
| Salt Lake Research | |
| Salt Lake City, Utah, United States, 84107 | |
| Radiant Research Salt Lake City | |
| Salt Lake City, Utah, United States, 84107 | |
| Granger Medical Clinic | |
| West Valley City, Utah, United States, 84120 | |
| United States, Virginia | |
| Clinical Research Associates of Tidewater | |
| Norfolk, Virginia, United States, 23507 | |
| Sentara Medical Group | |
| Virginia Beach, Virginia, United States, 23462 | |
| United States, Washington | |
| Larry D Stonesifer MD Inc PS | |
| Federal Way, Washington, United States, 98003 | |
| Rainier Clinical Research Center Inc | |
| Renton, Washington, United States, 98055 | |
| Liberty Research Center | |
| Tacoma, Washington, United States, 98405 | |
| Cedar Research | |
| Tacoma, Washington, United States, 98405 | |
| Wenatchee Valley Medical Center Clinical Research Department | |
| Wenatchee, Washington, United States, 98801 | |
| Brazil | |
| Hospital de Clinicas de Porto Alegre | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90035-903 | |
| CPClin-Centro de Pesquisas Clinicas | |
| Sao Paulo, Brazil, 01244-030 | |
| Canada, Ontario | |
| Aggarwal and Associates Ltd | |
| Brampton, Ontario, Canada, L6T 3J1 | |
| Parkwood Hospital | |
| London, Ontario, Canada, N6C 5J1 | |
| Quest Clinical Trials | |
| Markham, Ontario, Canada, L6C 1Y9 | |
| Lifestyle Metabolism Center | |
| Oakville, Ontario, Canada, L6H 3P1 | |
| The London Road Diagnostic Clinic and Medical Centre | |
| Sarnia, Ontario, Canada, N7T 4X3 | |
| Sarnia Institute of Clinical Research | |
| Sarnia, Ontario, Canada, N7T 4X3 | |
| Lifestyle Metabolism Center | |
| Thornhill, Ontario, Canada, L4J 8L7 | |
| Manna Research | |
| Toronto, Ontario, Canada, M9W 4L6 | |
| Trial Management Group Inc (Henein | |
| Toronto, Ontario, Canada, M4T 1N5 | |
| Lifestyle Metabolism Center | |
| Toronto, Ontario, Canada, M4R 2G4 | |
| Russian Federation | |
| Kemerovo State Medical Academy of Ministry of Health | |
| Kemerovo, RUS, Russian Federation, 650061 | |
| NHI Kemerovo Regional Clinical Hospital | |
| Kemerovo, RUS, Russian Federation, 650061 | |
| Russian State Medical University City Hospital # 4 | |
| Moscow, RUS, Russian Federation, 113093 | |
| SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology | |
| Moscow, RUS, Russian Federation, 127644 | |
| RAAMS Endocrinology and Diabetology Department | |
| Moscow, RUS, Russian Federation, 125315 | |
| SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology | |
| Moscow, RUS, Russian Federation, 119435 | |
| SHI of Moscow City Clinical Hospital #13 | |
| Moscow, RUS, Russian Federation, 115280 | |
| SI Internal Affairs of Moscow- Clinical Hospital | |
| Moscow, RUS, Russian Federation, 125299 | |
| Russian State Medical University Central Clinical Hospital Russian Science Academy | |
| Moscow, RUS, Russian Federation, 117593 | |
| NI Central Clinical Hospital of RAS | |
| Moscow, RUS, Russian Federation, 117 593 | |
| Moscow State Medical-Stomatological University City Clinical Hospital # 23 | |
| Moscow, RUS, Russian Federation, 109240 | |
| NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense | |
| Moscow, RUS, Russian Federation, 105229 | |
| Russian Scientific Center of Restoration Medicine & Balneology | |
| Moscow, RUS, Russian Federation, 121069 | |
| Moscow City Clinical Hospital # 13 | |
| Moscow, RUS, Russian Federation, 115280 | |
| NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70 | |
| Moscow, RUS, Russian Federation, 111399 | |
| City Clinical Hospital # 61 | |
| Moscow, RUS, Russian Federation, 119048 | |
| Ryazan State Medical University na academician IP Pavlov | |
| Ryazan, RUS, Russian Federation, 390026 | |
| NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital | |
| Smolensk, RUS, Russian Federation, 214018 | |
| St Petersburg NHI City Polytclinic #77 City Diabetological Center #4 | |
| St Petersburg, RUS, Russian Federation, 193012 | |
| Pavlov State Medical Univ of St Petersburg | |
| St Petersburg, RUS, Russian Federation, 197022 | |
| TUV Medico-Military Academy | |
| St Petersburg, RUS, Russian Federation, 198013 | |
| Central Medical Sanitary Unit #122 | |
| St Petersburg, RUS, Russian Federation, 194291 | |
| St Petersburg Medical Academy St Elizabeth Hospital | |
| St Petersburg, RUS, Russian Federation, 195257 | |
| St Petersburg NHI Municipal Multi-Speciality Hospital # 2 | |
| St. Petersburg, RUS, Russian Federation, 194354 | |
| NHI Yaroslavl Regional Clinical Hospital | |
| Yaroslavl, RUS, Russian Federation, 150062 | |
| Yaroslavl Regional Clinical Hospital | |
| Yaroslavl, RUS, Russian Federation, 150062 | |
| Clinical Pharm Dept of Yaroslavl Clin Hospital | |
| Yaroslavl, RUS, Russian Federation, 150003 | |
| MHI Clinical Hospital for Emergency Care na NV Soloviev | |
| Yaroslavl, RUS, Russian Federation, 150003 | |
| MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant | |
| Yaroslavl, RUS, Russian Federation, 150023 | |
Sponsors and Collaborators
Mannkind Corporation
More Information
No publications provided
| Responsible Party: | Anders Boss, MD, MFPM, MannKind Corporation |
| ClinicalTrials.gov Identifier: | NCT00741429 History of Changes |
| Other Study ID Numbers: | MKC-TI-126 |
| Study First Received: | August 22, 2008 |
| Last Updated: | October 1, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013