Type 2 Diabetes Clinical Trial
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
Verified date | December 2014 |
Source | Mannkind Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 649 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul |
Brazil | CPClin-Centro de Pesquisas Clinicas | Sao Paulo | |
Canada | Aggarwal and Associates Ltd | Brampton | Ontario |
Canada | Parkwood Hospital | London | Ontario |
Canada | Quest Clinical Trials | Markham | Ontario |
Canada | Lifestyle Metabolism Center | Oakville | Ontario |
Canada | Sarnia Institute of Clinical Research | Sarnia | Ontario |
Canada | The London Road Diagnostic Clinic and Medical Centre | Sarnia | Ontario |
Canada | Lifestyle Metabolism Center | Thornhill | Ontario |
Canada | Lifestyle Metabolism Center | Toronto | Ontario |
Canada | Manna Research | Toronto | Ontario |
Canada | Trial Management Group Inc (Henein | Toronto | Ontario |
Russian Federation | Kemerovo State Medical Academy of Ministry of Health | Kemerovo | RUS |
Russian Federation | NHI Kemerovo Regional Clinical Hospital | Kemerovo | RUS |
Russian Federation | City Clinical Hospital # 61 | Moscow | RUS |
Russian Federation | Moscow City Clinical Hospital # 13 | Moscow | RUS |
Russian Federation | Moscow State Medical-Stomatological University City Clinical Hospital # 23 | Moscow | RUS |
Russian Federation | NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70 | Moscow | RUS |
Russian Federation | NI Central Clinical Hospital of RAS | Moscow | RUS |
Russian Federation | NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense | Moscow | RUS |
Russian Federation | RAAMS Endocrinology and Diabetology Department | Moscow | RUS |
Russian Federation | Russian Scientific Center of Restoration Medicine & Balneology | Moscow | RUS |
Russian Federation | Russian State Medical University Central Clinical Hospital Russian Science Academy | Moscow | RUS |
Russian Federation | Russian State Medical University City Hospital # 4 | Moscow | RUS |
Russian Federation | SEI HPE Moscow Medical Academy IM Sechenov of Roszdrav Clinic of Endocrinology | Moscow | RUS |
Russian Federation | SHI of Moscow City Clinical Hospital #13 | Moscow | RUS |
Russian Federation | SI Internal Affairs of Moscow- Clinical Hospital | Moscow | RUS |
Russian Federation | SIH of Moscow City Clinical Hopsital #81 Endocrinology and Diabetology | 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 | Central Medical Sanitary Unit #122 | St Petersburg | RUS |
Russian Federation | Pavlov State Medical Univ of St Petersburg | St Petersburg | RUS |
Russian Federation | St Petersburg Medical Academy St Elizabeth Hospital | St Petersburg | RUS |
Russian Federation | St Petersburg NHI City Polytclinic #77 City Diabetological Center #4 | St Petersburg | RUS |
Russian Federation | TUV Medico-Military Academy | St Petersburg | RUS |
Russian Federation | St Petersburg NHI Municipal Multi-Speciality Hospital # 2 | St. Petersburg | RUS |
Russian Federation | Clinical Pharm Dept of Yaroslavl Clin Hospital | Yaroslavl | RUS |
Russian Federation | MCHI Medical Sanitary Unit of Novo-Yaroslavsky Oil Refining Plant | Yaroslavl | RUS |
Russian Federation | MHI Clinical Hospital for Emergency Care na NV Soloviev | Yaroslavl | RUS |
Russian Federation | NHI Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS |
Russian Federation | Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS |
United States | Lovelace Scientific Resources (Albuquerque) | Albuquerque | New Mexico |
United States | New Mexico Clinical Research & Osteoporosis Center | Albuquerque | New Mexico |
United States | Southwest Endocrinology Associates | Albuquerque | New Mexico |
United States | University of New Mexico HCS | Albuquerque | New Mexico |
United States | Israel Hartman MD | Arlington | Texas |
United States | Executive Health and Research Associates Inc | Atlanta | Georgia |
United States | Laureate Clinical Research Group | Atlanta | Georgia |
United States | Franklin Square Hospital | Baltimore | Maryland |
United States | Health Trends Research LLC | Baltimore | Maryland |
United States | MODEL Clinical Research | Baltimore | Maryland |
United States | AM Diabetes and Endocrinology Center | Bartlett | Tennessee |
United States | Deaconess Billings Clinic Research Center | Billings | Montana |
United States | Montana Health Research Institute | Billings | Montana |
United States | Parkway Medical Center | Birmingham | Alabama |
United States | Pharmaceutical Research Organization | Bountiful | Utah |
United States | Private Practice | Burlingame | California |
United States | Radiant Research (Phoenix) | Chandler | Arizona |
United States | Metrolina Medical Research | Charlotte | North Carolina |
United States | Sensenbrenner Primary Care | Charlotte | North Carolina |
United States | Cedar-Crosse Research Center | Chicago | Illinois |
United States | John H Stoger Jr Hospital of Cook County | Chicago | Illinois |
United States | International Clinical Research Network | Chula Vista | California |
United States | Rapid Medical Research Inc | Cleveland | Ohio |
United States | Texas Familicare Clinical Research | Colleyville | Texas |
United States | Collierville Medical Specialists | Collierville | Tennessee |
United States | Rockdale Medical Research Associates | Conyers | Georgia |
United States | Baylor Endocrine Center | Dallas | Texas |
United States | Dallas Diabetes & Endocrine Center | Dallas | Texas |
United States | Galenos Research | Dallas | Texas |
United States | North Texas Endocrine Center | Dallas | Texas |
United States | Radiant Research Dallas-North | Dallas | Texas |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Providence Health Partners - Center of Clinical Research | Dayton | Ohio |
United States | Private Practice | Decatur | Georgia |
United States | Creekside Endocrine Associates | Denver | Colorado |
United States | Atlanta Pharmaceutical Research Center | Dunwoody | Georgia |
United States | Radiant Research Inc (Minneapolis) | Edina | Minnesota |
United States | Larry D Stonesifer MD Inc PS | Federal Way | Washington |
United States | Hurley Medical Center | Flint | Michigan |
United States | Healthcare Research | Florissant | Missouri |
United States | Diabetes Care & Information Center of New York | Flushing | New York |
United States | Family Medical Center | Foothill Ranch | California |
United States | Saad Hijazi MD Inc | Fresno | California |
United States | Saint Agnes Medical Center | Fresno | California |
United States | Valley Research | Fresno | California |
United States | Spuhler Medical Associates | Friendswood | Texas |
United States | Digestive & Liver Disease Specialist A Medical Group Inc | Garden Grove | California |
United States | Physician's East PA | Greenville | North Carolina |
United States | Upstate Pharmaceutical Research | Greenville | South Carolina |
United States | Your Doctors Care | Hillsborough | New Jersey |
United States | Center for Diabetes & Endocrine Care | Hollywood | Florida |
United States | Diabetes/Lipid Management and Research Center | Huntington Beach | California |
United States | Wells Institute for Health Awareness | Kettering | Ohio |
United States | North Atlanta Endocrinology & Diabetes PC | Lawrenceville | Georgia |
United States | Interlink Research Institute | Los Alamitos | California |
United States | Magna Center for Family Medicine | Magna | Utah |
United States | Memphis Internal Medicine PLLC | Memphis | Tennessee |
United States | Your Diabetes Endocrine Nutrition Group | Mentor | Ohio |
United States | International Research Associates LLC | Miami | Florida |
United States | University of Miami Diabetes Research Institute | Miami | Florida |
United States | Winthrop University Hospital | Mineola | New York |
United States | Center for Urologic Clinical Trials University of Minnesota | Minneapolis | Minnesota |
United States | Coastal Clinical Research Inc | Mobile | Alabama |
United States | Bucks County Clinical Research | Morrisville | Pennsylvania |
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 | Clinical Research Associates of Tidewater | Norfolk | Virginia |
United States | Creighton Diabetes Center | Omaha | Nebraska |
United States | Southern California Endocrine Center | Pasadena | California |
United States | Northwest Medical Center | Phoenix | Arizona |
United States | Southwest Health Ltd Research Division | Phoenix | Arizona |
United States | SMO: Pharmaceuticals C-Trials North Texas Medical Research | Plano | Texas |
United States | Covance CRU Inc. | Portland | Oregon |
United States | Legacy Clinical Research | Portland | Oregon |
United States | Portland Diabetes & Endocrinology Center | Portland | Oregon |
United States | Rainier Clinical Research Center Inc | Renton | Washington |
United States | Endocrine Research Solutions, Inc. | Roswell | Georgia |
United States | Radiant Research Salt Lake City | Salt Lake City | Utah |
United States | Salt Lake Research | Salt Lake City | Utah |
United States | Clinical Trials of Texas Inc | San Antonio | Texas |
United States | Covenant Clinic Research | San Antonio | Texas |
United States | Diabetes & Glandular Disease Research Assoc PA | San Antonio | Texas |
United States | Quality Assurance Research Center Inc | San Antonio | Texas |
United States | SAM Clinical Research Center | San Antonio | Texas |
United States | Dorothy L & James E Frank Diabetes Research Institute | San Mateo | California |
United States | Sansum Medical Research Institute | Santa Barbara | California |
United States | Coastal Biomedical Research Inc | Santa Monica | California |
United States | Encompass Clinical Research | Spring Valley | California |
United States | KMED Research | St Clair Shores | Michigan |
United States | Clayton Medical Research | St Louis | Missouri |
United States | MedEx Healthcare Research Inc(009) | St Louis | Missouri |
United States | Amin Radparvar's Private Practice | St Peters | Missouri |
United States | Mercy Health Research | St. Louis | Missouri |
United States | Washington University School of Medicine | St. Louis | Missouri |
United States | Univeristy of Physicians Group Endocrine Division | Staten Island | New York |
United States | Cedar Research | Tacoma | Washington |
United States | Liberty Research Center | Tacoma | Washington |
United States | Southeastern Research Associates Inc | Taylors | South Carolina |
United States | Scott & White Hospital and Clinic | Temple | Texas |
United States | James A Dicke MDPA | Towson | Maryland |
United States | Hopewell Valley Medical Group | Trenton | New Jersey |
United States | Canyon Clinical Research | Tucson | Arizona |
United States | Arizona Research Associates | Tuscon | Arizona |
United States | Diabetes Research Center | Tustin | California |
United States | Sentara Medical Group | Virginia Beach | Virginia |
United States | Umdnj-Som | Voorhees | New Jersey |
United States | Chase Medical Research LLC | Waterbury | Connecticut |
United States | Wenatchee Valley Medical Center Clinical Research Department | Wenatchee | Washington |
United States | Granger Medical Clinic | West Valley City | Utah |
Lead Sponsor | Collaborator |
---|---|
Mannkind Corporation |
United States, Brazil, Canada, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 | 9 to 27 months | Yes | |
Secondary | Change in FVC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 | 9 to 27 months | Yes | |
Secondary | Change in TLC (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 | 9 to 27 months | Yes | |
Secondary | 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 | Yes | |
Secondary | Change in FEV1 (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 | 3 Months | Yes | |
Secondary | Change in FVC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 | 3 Months | Yes | |
Secondary | Change in TLC (L) from Final Assessment of Treatment Phase in Parent Trial to Visit 2 of MKC-TI-126 | 3 Months | Yes | |
Secondary | 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 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05219994 -
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
|
N/A | |
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Completed |
NCT02284893 -
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
|
Phase 3 | |
Completed |
NCT04274660 -
Evaluation of Diabetes and WELLbeing Programme
|
N/A | |
Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
Active, not recruiting |
NCT05566847 -
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Completed |
NCT04965506 -
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Active, not recruiting |
NCT03982381 -
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
Completed |
NCT04023539 -
Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05530356 -
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
|
||
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Completed |
NCT04097600 -
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
|
Phase 1 | |
Completed |
NCT05378282 -
Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
|
||
Active, not recruiting |
NCT06010004 -
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT03653091 -
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
|
N/A |