A 2-Month Safety Follow-Up Trial
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
1 other identifier
observational
649
4 countries
150
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2007
150 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
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 22, 2008
CompletedFirst Posted
Study publicly available on registry
August 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedDecember 3, 2014
December 1, 2014
1.3 years
August 22, 2008
December 1, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126
9 to 27 months
Secondary Outcomes (7)
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
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
- +2 more secondary outcomes
Study Arms (2)
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)
Interventions
Subjects previously treated with Technosphere Insulin Inhalation Powder
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (150)
Parkway Medical Center
Birmingham, Alabama, 35215, United States
Coastal Clinical Research Inc
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2008
First Posted
August 26, 2008
Study Start
May 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
December 3, 2014
Record last verified: 2014-12