A 2-Month Safety Follow-Up Trial
- Conditions
- Type 2 DiabetesType 1 Diabetes
- Interventions
- Drug: ComparatorDrug: Technosphere Insulin Inhalation Powder
- Registration Number
- NCT00741429
- Lead Sponsor
- Mannkind Corporation
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 649
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non Ex-TI Comparator Non Ex-Technosphere® Insulin Inhalation Powder (subjects previously received another anti-diabetic medication) Ex-TI Technosphere Insulin Inhalation Powder Ex-Technosphere® Insulin Inhalation Powder (subjects previously received TI Inhalation Powder)
- Primary Outcome Measures
Name Time Method Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 9 to 27 months
- Secondary Outcome Measures
Name Time Method 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 FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 3 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 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
Trial Locations
- Locations (147)
Private Practice
🇺🇸Decatur, Georgia, United States
Laureate Clinical Research Group
🇺🇸Atlanta, Georgia, United States
Executive Health and Research Associates Inc
🇺🇸Atlanta, Georgia, United States
Atlanta Pharmaceutical Research Center
🇺🇸Dunwoody, Georgia, United States
Univeristy of Physicians Group Endocrine Division
🇺🇸Staten Island, New York, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Franklin Square Hospital
🇺🇸Baltimore, Maryland, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Radiant Research Dallas-North
🇺🇸Dallas, Texas, United States
Sentara Medical Group
🇺🇸Virginia Beach, Virginia, United States
Wenatchee Valley Medical Center Clinical Research Department
🇺🇸Wenatchee, Washington, United States
Trial Management Group Inc (Henein
🇨🇦Toronto, Ontario, Canada
Rapid Medical Research Inc
🇺🇸Cleveland, Ohio, United States
University of Miami Diabetes Research Institute
🇺🇸Miami, Florida, United States
Center for Urologic Clinical Trials University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Diabetes & Glandular Disease Research Assoc PA
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas Inc
🇺🇸San Antonio, Texas, United States
Covenant Clinic Research
🇺🇸San Antonio, Texas, United States
Radiant Research Salt Lake City
🇺🇸Salt Lake City, Utah, United States
SAM Clinical Research Center
🇺🇸San Antonio, Texas, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Southwest Health Ltd Research Division
🇺🇸Phoenix, Arizona, United States
Northwest Medical Center
🇺🇸Phoenix, Arizona, United States
Sansum Medical Research Institute
🇺🇸Santa Barbara, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Coastal Biomedical Research Inc
🇺🇸Santa Monica, California, United States
Chase Medical Research LLC
🇺🇸Waterbury, Connecticut, United States
Center for Diabetes & Endocrine Care
🇺🇸Hollywood, Florida, United States
International Research Associates LLC
🇺🇸Miami, Florida, United States
Rockdale Medical Research Associates
🇺🇸Conyers, Georgia, United States
MODEL Clinical Research
🇺🇸Baltimore, Maryland, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
John H Stoger Jr Hospital of Cook County
🇺🇸Chicago, Illinois, United States
James A Dicke MDPA
🇺🇸Towson, Maryland, United States
Health Trends Research LLC
🇺🇸Baltimore, Maryland, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Amin Radparvar's Private Practice
🇺🇸St Peters, Missouri, United States
Mercy Health Research
🇺🇸St. Louis, Missouri, United States
Montana Health Research Institute
🇺🇸Billings, Montana, United States
Physician's East PA
🇺🇸Greenville, North Carolina, United States
Providence Health Partners - Center of Clinical Research
🇺🇸Dayton, Ohio, United States
Collierville Medical Specialists
🇺🇸Collierville, Tennessee, United States
Wells Institute for Health Awareness
🇺🇸Kettering, Ohio, United States
Your Diabetes Endocrine Nutrition Group
🇺🇸Mentor, Ohio, United States
Texas Familicare Clinical Research
🇺🇸Colleyville, Texas, United States
Dallas Diabetes & Endocrine Center
🇺🇸Dallas, Texas, United States
Galenos Research
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
North Texas Endocrine Center
🇺🇸Dallas, Texas, United States
Quality Assurance Research Center Inc
🇺🇸San Antonio, Texas, United States
SMO: Pharmaceuticals C-Trials North Texas Medical Research
🇺🇸Plano, Texas, United States
Scott & White Hospital and Clinic
🇺🇸Temple, Texas, United States
Magna Center for Family Medicine
🇺🇸Magna, Utah, United States
Spuhler Medical Associates
🇺🇸Friendswood, Texas, United States
Pharmaceutical Research Organization
🇺🇸Bountiful, Utah, United States
Clinical Research Associates of Tidewater
🇺🇸Norfolk, Virginia, United States
Larry D Stonesifer MD Inc PS
🇺🇸Federal Way, Washington, United States
Parkwood Hospital
🇨🇦London, Ontario, Canada
The London Road Diagnostic Clinic and Medical Centre
🇨🇦Sarnia, Ontario, Canada
Quest Clinical Trials
🇨🇦Markham, Ontario, Canada
NHI Kemerovo Regional Clinical Hospital
🇷🇺Kemerovo, RUS, Russian Federation
NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense
🇷🇺Moscow, RUS, Russian Federation
Moscow State Medical-Stomatological University City Clinical Hospital # 23
🇷🇺Moscow, RUS, Russian Federation
NHI Yaroslavl Regional Clinical Hospital
🇷🇺Yaroslavl, RUS, Russian Federation
St Petersburg Medical Academy St Elizabeth Hospital
🇷🇺St Petersburg, RUS, Russian Federation
MHI Clinical Hospital for Emergency Care na NV Soloviev
🇷🇺Yaroslavl, RUS, Russian Federation
Creekside Endocrine Associates
🇺🇸Denver, Colorado, United States
Portland Diabetes & Endocrinology Center
🇺🇸Portland, Oregon, United States
Legacy Clinical Research
🇺🇸Portland, Oregon, United States
Coastal Clinical Research Inc
🇺🇸Mobile, Alabama, United States
Family Medical Center
🇺🇸Foothill Ranch, California, United States
Interlink Research Institute
🇺🇸Los Alamitos, California, United States
Saad Hijazi MD Inc
🇺🇸Fresno, California, United States
Saint Agnes Medical Center
🇺🇸Fresno, California, United States
Diabetes/Lipid Management and Research Center
🇺🇸Huntington Beach, California, United States
Valley Research
🇺🇸Fresno, California, United States
Southern California Endocrine Center
🇺🇸Pasadena, California, United States
Creighton Diabetes Center
🇺🇸Omaha, Nebraska, United States
Lifestyle Metabolism Center
🇨🇦Toronto, Ontario, Canada
Manna Research
🇨🇦Toronto, Ontario, Canada
Digestive & Liver Disease Specialist A Medical Group Inc
🇺🇸Garden Grove, California, United States
Dorothy L & James E Frank Diabetes Research Institute
🇺🇸San Mateo, California, United States
Covance CRU Inc.
🇺🇸Portland, Oregon, United States
Israel Hartman MD
🇺🇸Arlington, Texas, United States
Baylor Endocrine Center
🇺🇸Dallas, Texas, United States
Diabetes Research Center
🇺🇸Tustin, California, United States
Bucks County Clinical Research
🇺🇸Morrisville, Pennsylvania, United States
Rainier Clinical Research Center Inc
🇺🇸Renton, Washington, United States
Radiant Research (Phoenix)
🇺🇸Chandler, Arizona, United States
North Atlanta Endocrinology & Diabetes PC
🇺🇸Lawrenceville, Georgia, United States
MedEx Healthcare Research Inc(009)
🇺🇸St Louis, Missouri, United States
KMED Research
🇺🇸St Clair Shores, Michigan, United States
Radiant Research Inc (Minneapolis)
🇺🇸Edina, Minnesota, United States
Clayton Medical Research
🇺🇸St Louis, Missouri, United States
Healthcare Research
🇺🇸Florissant, Missouri, United States
Southwest Endocrinology Associates
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico HCS
🇺🇸Albuquerque, New Mexico, United States
New Mexico Clinical Research & Osteoporosis Center
🇺🇸Albuquerque, New Mexico, United States
Lovelace Scientific Resources (Albuquerque)
🇺🇸Albuquerque, New Mexico, United States
Diabetes Care & Information Center of New York
🇺🇸Flushing, New York, United States
North Shore Diabetes and Endocrine Associates
🇺🇸New Hyde Park, New York, United States
M.E.R.I.
🇺🇸New York, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Sensenbrenner Primary Care
🇺🇸Charlotte, North Carolina, United States
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Granger Medical Clinic
🇺🇸West Valley City, Utah, United States
Cedar Research
🇺🇸Tacoma, Washington, United States
Liberty Research Center
🇺🇸Tacoma, Washington, United States
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Aggarwal and Associates Ltd
🇨🇦Brampton, Ontario, Canada
CPClin-Centro de Pesquisas Clinicas
🇧🇷Sao Paulo, Brazil
Sarnia Institute of Clinical Research
🇨🇦Sarnia, Ontario, Canada
Kemerovo State Medical Academy of Ministry of Health
🇷🇺Kemerovo, RUS, Russian Federation
Moscow City Clinical Hospital # 13
🇷🇺Moscow, RUS, Russian Federation
SHI of Moscow City Clinical Hospital #13
🇷🇺Moscow, RUS, Russian Federation
NI Central Clinical Hospital of RAS
🇷🇺Moscow, RUS, Russian Federation
RAAMS Endocrinology and Diabetology Department
🇷🇺Moscow, RUS, Russian Federation
SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology
🇷🇺Moscow, RUS, Russian Federation
Central Medical Sanitary Unit #122
🇷🇺St Petersburg, RUS, Russian Federation
TUV Medico-Military Academy
🇷🇺St Petersburg, RUS, Russian Federation
Clinical Pharm Dept of Yaroslavl Clin Hospital
🇷🇺Yaroslavl, RUS, Russian Federation
Pavlov State Medical Univ of St Petersburg
🇷🇺St Petersburg, RUS, Russian Federation
MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant
🇷🇺Yaroslavl, RUS, Russian Federation
Yaroslavl Regional Clinical Hospital
🇷🇺Yaroslavl, RUS, Russian Federation
Arizona Research Associates
🇺🇸Tuscon, Arizona, United States
Parkway Medical Center
🇺🇸Birmingham, Alabama, United States
Umdnj-Som
🇺🇸Voorhees, New Jersey, United States
Canyon Clinical Research
🇺🇸Tucson, Arizona, United States
Deaconess Billings Clinic Research Center
🇺🇸Billings, Montana, United States
Your Doctors Care
🇺🇸Hillsborough, New Jersey, United States
Hopewell Valley Medical Group
🇺🇸Trenton, New Jersey, United States
AM Diabetes and Endocrinology Center
🇺🇸Bartlett, Tennessee, United States
NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70
🇷🇺Moscow, RUS, Russian Federation
Russian State Medical University City Hospital # 4
🇷🇺Moscow, RUS, Russian Federation
Russian State Medical University Central Clinical Hospital Russian Science Academy
🇷🇺Moscow, RUS, Russian Federation
City Clinical Hospital # 61
🇷🇺Moscow, RUS, Russian Federation
Southeastern Research Associates Inc
🇺🇸Taylors, South Carolina, United States
Upstate Pharmaceutical Research
🇺🇸Greenville, South Carolina, United States
SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology
🇷🇺Moscow, RUS, Russian Federation
Russian Scientific Center of Restoration Medicine & Balneology
🇷🇺Moscow, RUS, Russian Federation
SI Internal Affairs of Moscow- Clinical Hospital
🇷🇺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
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
Memphis Internal Medicine PLLC
🇺🇸Memphis, Tennessee, United States
International Clinical Research Network
🇺🇸Chula Vista, California, United States