A 2-Month Safety Follow-Up Trial
Sponsor
Mannkind Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00741429
Collaborator
(none)
649
150
16.1
4.3
0.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
649 participants
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
Study Start Date
:
May 1, 2007
Actual Primary Completion Date
:
Sep 1, 2008
Actual Study Completion Date
:
Sep 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ex-TI Ex-Technosphere® Insulin Inhalation Powder (subjects previously received TI Inhalation Powder) |
Drug: Technosphere Insulin Inhalation Powder
Subjects previously treated with Technosphere Insulin Inhalation Powder
|
| Non Ex-TI Non Ex-Technosphere® Insulin Inhalation Powder (subjects previously received another anti-diabetic medication) |
Drug: Comparator
Subjects previously treated with other anti-diabetic medications
|
Outcome Measures
Primary Outcome Measures
- Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 [9 to 27 months]
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Parkway Medical Center | Birmingham | Alabama | United States | 35215 |
| 2 | Coastal Clinical Research Inc | Mobile | Alabama | United States | 36608 |
| 3 | Radiant Research (Phoenix) | Chandler | Arizona | United States | 85225 |
| 4 | Southwest Health Ltd Research Division | Phoenix | Arizona | United States | 85016 |
| 5 | Northwest Medical Center | Phoenix | Arizona | United States | 85029 |
| 6 | Canyon Clinical Research | Tucson | Arizona | United States | 85712 |
| 7 | Arizona Research Associates | Tuscon | Arizona | United States | 85712 |
| 8 | Private Practice | Burlingame | California | United States | 94010 |
| 9 | International Clinical Research Network | Chula Vista | California | United States | 91911 |
| 10 | Family Medical Center | Foothill Ranch | California | United States | 92610 |
| 11 | Saad Hijazi MD Inc | Fresno | California | United States | 93710 |
| 12 | Saint Agnes Medical Center | Fresno | California | United States | 93720 |
| 13 | Valley Research | Fresno | California | United States | 93720 |
| 14 | Digestive & Liver Disease Specialist A Medical Group Inc | Garden Grove | California | United States | 92840 |
| 15 | Diabetes/Lipid Management and Research Center | Huntington Beach | California | United States | 92648 |
| 16 | Interlink Research Institute | Los Alamitos | California | United States | 90720 |
| 17 | Southern California Endocrine Center | Pasadena | California | United States | 91105 |
| 18 | Dorothy L & James E Frank Diabetes Research Institute | San Mateo | California | United States | 94401 |
| 19 | Sansum Medical Research Institute | Santa Barbara | California | United States | 93105 |
| 20 | Coastal Biomedical Research Inc | Santa Monica | California | United States | 90404 |
| 21 | Encompass Clinical Research | Spring Valley | California | United States | 91978 |
| 22 | Diabetes Research Center | Tustin | California | United States | 92780 |
| 23 | Creekside Endocrine Associates | Denver | Colorado | United States | 80209 |
| 24 | Chase Medical Research LLC | Waterbury | Connecticut | United States | 06708 |
| 25 | Center for Diabetes & Endocrine Care | Hollywood | Florida | United States | 33021 |
| 26 | University of Miami Diabetes Research Institute | Miami | Florida | United States | 33136 |
| 27 | International Research Associates LLC | Miami | Florida | United States | 33156 |
| 28 | Laureate Clinical Research Group | Atlanta | Georgia | United States | 30308 |
| 29 | Executive Health and Research Associates Inc | Atlanta | Georgia | United States | 30342 |
| 30 | Rockdale Medical Research Associates | Conyers | Georgia | United States | 30094 |
| 31 | Private Practice | Decatur | Georgia | United States | 30035 |
| 32 | Atlanta Pharmaceutical Research Center | Dunwoody | Georgia | United States | 30338 |
| 33 | North Atlanta Endocrinology & Diabetes PC | Lawrenceville | Georgia | United States | 30045 |
| 34 | Endocrine Research Solutions, Inc. | Roswell | Georgia | United States | 30076 |
| 35 | Cedar-Crosse Research Center | Chicago | Illinois | United States | 60607 |
| 36 | John H Stoger Jr Hospital of Cook County | Chicago | Illinois | United States | 60612 |
| 37 | MODEL Clinical Research | Baltimore | Maryland | United States | 21204 |
| 38 | Health Trends Research LLC | Baltimore | Maryland | United States | 21209 |
| 39 | Franklin Square Hospital | Baltimore | Maryland | United States | 21237 |
| 40 | James A Dicke MDPA | Towson | Maryland | United States | 21204 |
| 41 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 42 | KMED Research | St Clair Shores | Michigan | United States | 48081 |
| 43 | Radiant Research Inc (Minneapolis) | Edina | Minnesota | United States | 55435 |
| 44 | Center for Urologic Clinical Trials University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 45 | Healthcare Research | Florissant | Missouri | United States | 63031 |
| 46 | Clayton Medical Research | St Louis | Missouri | United States | 63117 |
| 47 | MedEx Healthcare Research Inc(009) | St Louis | Missouri | United States | 63117 |
| 48 | Amin Radparvar's Private Practice | St Peters | Missouri | United States | 63376 |
| 49 | Washington University School of Medicine | St. Louis | Missouri | United States | 63110 |
| 50 | Mercy Health Research | St. Louis | Missouri | United States | 63141 |
| 51 | Deaconess Billings Clinic Research Center | Billings | Montana | United States | 59101 |
| 52 | Montana Health Research Institute | Billings | Montana | United States | 59102 |
| 53 | Creighton Diabetes Center | Omaha | Nebraska | United States | 68131 |
| 54 | Your Doctors Care | Hillsborough | New Jersey | United States | 08844 |
| 55 | Hopewell Valley Medical Group | Trenton | New Jersey | United States | 08618 |
| 56 | Umdnj-Som | Voorhees | New Jersey | United States | 08043 |
| 57 | New Mexico Clinical Research & Osteoporosis Center | Albuquerque | New Mexico | United States | 87106 |
| 58 | Lovelace Scientific Resources (Albuquerque) | Albuquerque | New Mexico | United States | 87108 |
| 59 | Southwest Endocrinology Associates | Albuquerque | New Mexico | United States | 87109 |
| 60 | University of New Mexico HCS | Albuquerque | New Mexico | United States | 87131 |
| 61 | Diabetes Care & Information Center of New York | Flushing | New York | United States | 11365 |
| 62 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
| 63 | North Shore Diabetes and Endocrine Associates | New Hyde Park | New York | United States | 11042 |
| 64 | M.E.R.I. | New York | New York | United States | 10023 |
| 65 | Univeristy of Physicians Group Endocrine Division | Staten Island | New York | United States | 10301 |
| 66 | Metrolina Medical Research | Charlotte | North Carolina | United States | 28209 |
| 67 | Sensenbrenner Primary Care | Charlotte | North Carolina | United States | 28277 |
| 68 | Physician's East PA | Greenville | North Carolina | United States | 27834 |
| 69 | Rapid Medical Research Inc | Cleveland | Ohio | United States | 44122 |
| 70 | Providence Health Partners - Center of Clinical Research | Dayton | Ohio | United States | 45439 |
| 71 | Wells Institute for Health Awareness | Kettering | Ohio | United States | 45429 |
| 72 | Your Diabetes Endocrine Nutrition Group | Mentor | Ohio | United States | 44060 |
| 73 | Portland Diabetes & Endocrinology Center | Portland | Oregon | United States | 97210 |
| 74 | Legacy Clinical Research | Portland | Oregon | United States | 97232 |
| 75 | Covance CRU Inc. | Portland | Oregon | United States | 97239 |
| 76 | Bucks County Clinical Research | Morrisville | Pennsylvania | United States | 19067 |
| 77 | Upstate Pharmaceutical Research | Greenville | South Carolina | United States | 29615 |
| 78 | Southeastern Research Associates Inc | Taylors | South Carolina | United States | 29687 |
| 79 | AM Diabetes and Endocrinology Center | Bartlett | Tennessee | United States | 38133 |
| 80 | Collierville Medical Specialists | Collierville | Tennessee | United States | 38017 |
| 81 | Memphis Internal Medicine PLLC | Memphis | Tennessee | United States | 38119 |
| 82 | Israel Hartman MD | Arlington | Texas | United States | 76014 |
| 83 | Texas Familicare Clinical Research | Colleyville | Texas | United States | 76034 |
| 84 | Dallas Diabetes & Endocrine Center | Dallas | Texas | United States | 75230 |
| 85 | North Texas Endocrine Center | Dallas | Texas | United States | 75231 |
| 86 | Radiant Research Dallas-North | Dallas | Texas | United States | 75231 |
| 87 | Baylor Endocrine Center | Dallas | Texas | United States | 75246 |
| 88 | Galenos Research | Dallas | Texas | United States | 75251 |
| 89 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 90 | Spuhler Medical Associates | Friendswood | Texas | United States | 77546 |
| 91 | SMO: Pharmaceuticals C-Trials North Texas Medical Research | Plano | Texas | United States | 75093 |
| 92 | Quality Assurance Research Center Inc | San Antonio | Texas | United States | 78205 |
| 93 | Clinical Trials of Texas Inc | San Antonio | Texas | United States | 78229 |
| 94 | Covenant Clinic Research | San Antonio | Texas | United States | 78229 |
| 95 | Diabetes & Glandular Disease Research Assoc PA | San Antonio | Texas | United States | 78229 |
| 96 | SAM Clinical Research Center | San Antonio | Texas | United States | 78229 |
| 97 | Scott & White Hospital and Clinic | Temple | Texas | United States | 76508 |
| 98 | Pharmaceutical Research Organization | Bountiful | Utah | United States | 84010 |
| 99 | Magna Center for Family Medicine | Magna | Utah | United States | 84044 |
| 100 | Radiant Research Salt Lake City | Salt Lake City | Utah | United States | 84107 |
| 101 | Salt Lake Research | Salt Lake City | Utah | United States | 84107 |
| 102 | Granger Medical Clinic | West Valley City | Utah | United States | 84120 |
| 103 | Clinical Research Associates of Tidewater | Norfolk | Virginia | United States | 23507 |
| 104 | Sentara Medical Group | Virginia Beach | Virginia | United States | 23462 |
| 105 | Larry D Stonesifer MD Inc PS | Federal Way | Washington | United States | 98003 |
| 106 | Rainier Clinical Research Center Inc | Renton | Washington | United States | 98055 |
| 107 | Cedar Research | Tacoma | Washington | United States | 98405 |
| 108 | Liberty Research Center | Tacoma | Washington | United States | 98405 |
| 109 | Wenatchee Valley Medical Center Clinical Research Department | Wenatchee | Washington | United States | 98801 |
| 110 | Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil | 90035-903 |
| 111 | CPClin-Centro de Pesquisas Clinicas | Sao Paulo | Brazil | 01244-030 | |
| 112 | Aggarwal and Associates Ltd | Brampton | Ontario | Canada | L6T 3J1 |
| 113 | Parkwood Hospital | London | Ontario | Canada | N6C 5J1 |
| 114 | Quest Clinical Trials | Markham | Ontario | Canada | L6C 1Y9 |
| 115 | Lifestyle Metabolism Center | Oakville | Ontario | Canada | L6H 3P1 |
| 116 | Sarnia Institute of Clinical Research | Sarnia | Ontario | Canada | N7T 4X3 |
| 117 | The London Road Diagnostic Clinic and Medical Centre | Sarnia | Ontario | Canada | N7T 4X3 |
| 118 | Lifestyle Metabolism Center | Thornhill | Ontario | Canada | L4J 8L7 |
| 119 | Lifestyle Metabolism Center | Toronto | Ontario | Canada | M4R 2G4 |
| 120 | Trial Management Group Inc (Henein | Toronto | Ontario | Canada | M4T 1N5 |
| 121 | Manna Research | Toronto | Ontario | Canada | M9W 4L6 |
| 122 | Kemerovo State Medical Academy of Ministry of Health | Kemerovo | RUS | Russian Federation | 650061 |
| 123 | NHI Kemerovo Regional Clinical Hospital | Kemerovo | RUS | Russian Federation | 650061 |
| 124 | NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense | Moscow | RUS | Russian Federation | 105229 |
| 125 | Moscow State Medical-Stomatological University City Clinical Hospital # 23 | Moscow | RUS | Russian Federation | 109240 |
| 126 | NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70 | Moscow | RUS | Russian Federation | 111399 |
| 127 | Russian State Medical University City Hospital # 4 | Moscow | RUS | Russian Federation | 113093 |
| 128 | Moscow City Clinical Hospital # 13 | Moscow | RUS | Russian Federation | 115280 |
| 129 | SHI of Moscow City Clinical Hospital #13 | Moscow | RUS | Russian Federation | 115280 |
| 130 | NI Central Clinical Hospital of RAS | Moscow | RUS | Russian Federation | 117 593 |
| 131 | Russian State Medical University Central Clinical Hospital Russian Science Academy | Moscow | RUS | Russian Federation | 117593 |
| 132 | City Clinical Hospital # 61 | Moscow | RUS | Russian Federation | 119048 |
| 133 | SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology | Moscow | RUS | Russian Federation | 119435 |
| 134 | Russian Scientific Center of Restoration Medicine & Balneology | Moscow | RUS | Russian Federation | 121069 |
| 135 | SI Internal Affairs of Moscow- Clinical Hospital | Moscow | RUS | Russian Federation | 125299 |
| 136 | RAAMS Endocrinology and Diabetology Department | Moscow | RUS | Russian Federation | 125315 |
| 137 | SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology | Moscow | RUS | Russian Federation | 127644 |
| 138 | Ryazan State Medical University na academician IP Pavlov | Ryazan | RUS | Russian Federation | 390026 |
| 139 | NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital | Smolensk | RUS | Russian Federation | 214018 |
| 140 | St Petersburg NHI City Polytclinic #77 City Diabetological Center #4 | St Petersburg | RUS | Russian Federation | 193012 |
| 141 | Central Medical Sanitary Unit #122 | St Petersburg | RUS | Russian Federation | 194291 |
| 142 | St Petersburg Medical Academy St Elizabeth Hospital | St Petersburg | RUS | Russian Federation | 195257 |
| 143 | Pavlov State Medical Univ of St Petersburg | St Petersburg | RUS | Russian Federation | 197022 |
| 144 | TUV Medico-Military Academy | St Petersburg | RUS | Russian Federation | 198013 |
| 145 | St Petersburg NHI Municipal Multi-Speciality Hospital # 2 | St. Petersburg | RUS | Russian Federation | 194354 |
| 146 | Clinical Pharm Dept of Yaroslavl Clin Hospital | Yaroslavl | RUS | Russian Federation | 150003 |
| 147 | MHI Clinical Hospital for Emergency Care na NV Soloviev | Yaroslavl | RUS | Russian Federation | 150003 |
| 148 | MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant | Yaroslavl | RUS | Russian Federation | 150023 |
| 149 | NHI Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS | Russian Federation | 150062 |
| 150 | Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS | Russian Federation | 150062 |
Sponsors and Collaborators
- Mannkind Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00741429
Other Study ID Numbers:
- MKC-TI-126
First Posted:
Aug 26, 2008
Last Update Posted:
Dec 3, 2014
Last Verified:
Dec 1, 2014