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| Sponsor: | Mannkind Corporation |
|---|---|
| Information provided by: | Mannkind Corporation |
| ClinicalTrials.gov Identifier: | NCT00332488 |
Purpose
to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Technosphere Insulin Drug: Metformin & Secretagogues Drug: Technosphere Insulin & Metformin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-optimally Controlled on Combination Metformin and a Secretagogue. |
| Enrollment: | 547 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | October 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Technosphere Insulin
|
Drug: Technosphere Insulin
Inhalation, 15U/30U, prandial
|
|
2: Active Comparator
Metformin & Secretagogues
|
Drug: Metformin & Secretagogues
Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
|
|
3: Experimental
Technosphere & Metformin
|
Drug: Technosphere Insulin & Metformin
Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Radiant Research-Birmingham | |
| Birmingham, Alabama, United States, 35209 | |
| Parkway Medical Center | |
| Birmingham, Alabama, United States, 35215 | |
| United States, Arizona | |
| Redpoint Research | |
| Phoenix, Arizona, United States, 85029 | |
| Arizona Center for Clinical Research | |
| Phoenix, Arizona, United States, 85032 | |
| United States, California | |
| International Clinical Research Network | |
| Chula Vista, California, United States, 91911 | |
| United States, Colorado | |
| Jennifer Hone MD | |
| Denver, Colorado, United States, 80220 | |
| Creekside Endocrine Associates | |
| Denver, Colorado, United States, 80209 | |
| National Jewish Medical & Research Center | |
| Denver, Colorado, United States, 80206 | |
| 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 | |
| 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 | |
| Clintell Inc | |
| Skokie, Illinois, United States, 60076 | |
| United States, Maryland | |
| James A Dicke MDPA | |
| Towson, Maryland, United States, 21204 | |
| United States, Massachusetts | |
| East Coast Clinical Research Inc | |
| Haverhill, Massachusetts, United States, 01830 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| Michigan Institute of Medicine | |
| Livonia, Michigan, United States, 48152 | |
| United States, Missouri | |
| Raidant Research-St Louis | |
| St Louis, Missouri, United States, 63141 | |
| Clayton Medical Research | |
| St Louis, Missouri, United States, 63117 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Creighton Diabetes Center | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Mexico | |
| Lovelace Scientific Resources (Albuquerque) | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| North Shore Diabetes and Endocrine Associates | |
| New Hyde Park, New York, United States, 11042 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| United States, North Carolina | |
| Charlotte Clinical Research Inc | |
| Charlotte, North Carolina, United States, 28211 | |
| Sensenbrenner Primary Care | |
| Charlotte, North Carolina, United States, 28277 | |
| Metrolina Internal Medicine | |
| Charlotte, North Carolina, United States, 28204 | |
| Duke Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Providence Health Partners - Center of Clinical Research | |
| Dayton, Ohio, United States, 45439 | |
| Dayton Clinical Research | |
| Dayton, Ohio, United States, 45406 | |
| United States, Oregon | |
| Radiant Research | |
| Portland, Oregon, United States, 97239 | |
| United States, South Carolina | |
| Upstate Pharmaceutical Research | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Tennessee | |
| GoodLife Medical Center PLLC | |
| Memphis, Tennessee, United States, 38120 | |
| Memphis Internal Medicine (Kathawala) | |
| Memphis, Tennessee, United States, 38119 | |
| Collierville Medical Specialists | |
| Collierville, Tennessee, United States, 38017 | |
| United States, Texas | |
| Clinical Trials of Texas Inc | |
| San Antonio, Texas, United States, 78229 | |
| Covenant Clinic Research | |
| 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 | |
| Baylor Endocrine Center | |
| Dallas, Texas, United States, 75246 | |
| SAM Clinical Research Center | |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Cedar Research | |
| Tacoma, Washington, United States, 98405 | |
| Argentina | |
| Centro Endocrinologic Tiempo | |
| Buenos Aires, Argentina, C1117ABH | |
| CIMeL | |
| Buenos Aires, Argentina | |
| Hospital Italiano de Buenos Aires | |
| Buenos Aires, Argentina, C1181ACH | |
| Cons Asoc de Endocrinologia | |
| Buenos Aires, Argentina, C1425AGC | |
| Argentina, Buenos Aires | |
| Hospital Interzonal de Agudos Pedro Fiorito | |
| Avellaneda, Buenos Aires, Argentina, B1870ARG | |
| Brazil | |
| Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda | |
| Rio de Janeiro, Brazil, 22271-100 | |
| Hospital Guilherme Alvaro | |
| Santos, Brazil, 11045-904 | |
| Instituto de Pesquisa Clinica e Medicina Avancada | |
| Sao Paulo, Brazil, 05437-010 | |
| CPClin-Centro de Pesquisas Clinicas | |
| Sao Paulo, Brazil, 01244-030 | |
| UNIFRSP | |
| Sao Paulo, Brazil, 04020-050 | |
| Hospital do Rim e Hipertensao | |
| Sao Paulo, Brazil, 04025-011 | |
| Brazil, Rio Grande do Sul | |
| Hospital Sao Lucas da PUCRS | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90610-000 | |
| Hospital de Clinicas de Porto Alegre | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90035-903 | |
| Canada | |
| Unimedico Management | |
| Richmond Hill, Canada, L4C 9M7 | |
| Canada, Ontario | |
| Lifestyle Metabolism Center | |
| Oakville, Ontario, Canada, L6H 3P1 | |
| Lifestyle Metabolism Center | |
| Thornhill, Ontario, Canada, L4J 8L7 | |
| Lifestyle Metabolism Center | |
| Toronto, Ontario, Canada, M4R 2G4 | |
| Quest Clinical Trials | |
| Markham, Ontario, Canada, L6B 1A1 | |
| Trial Management Group Inc (Henein | |
| Toronto, Ontario, Canada, M4T 1N5 | |
| Chile | |
| Hospital Clinico Pontificia Universidad Catolica de Chile | |
| Santiago, Chile | |
| Hospital del Salvador | |
| Santiago, Chile | |
| Instituto de Informacion de Tramiento y Educacion en Salud | |
| Santiago, Chile | |
| Chile, Region Metropolitana | |
| Hospital Padre Alberto Hurtado | |
| Santiago, Region Metropolitana, Chile | |
| Czech Republic | |
| Diabetologicka ambulance (Chmura) | |
| Ostrava, Czech Republic, 70200 | |
| Endokrinologicky ustav | |
| Praha 1, Czech Republic, 11694 | |
| 3rd Medical Department General Faculty Hospital | |
| Praha 2, Czech Republic, 12801 | |
| II interni klinika FN Kralovske Vinohrady | |
| Praha 10, Czech Republic, 10034 | |
| Interní a diabetologická Outpatient | |
| Ostrava, Czech Republic, 70900 | |
| Czech Republic, CZE | |
| Institute for Clinical and Exp Medicine | |
| Prague 4, CZE, Czech Republic, 140 21 | |
| University Hospital Na Bulovce | |
| Prague 8, CZE, Czech Republic, 180 81 | |
| Diabetologicka a interni ambulance | |
| 707 02 Ostrava-Kuncice, CZE, Czech Republic, 70702 | |
| Mexico | |
| Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio | |
| Mexico City, Mexico, 06726 | |
| Centro de Estudios en Diabetes | |
| Mexico City, Mexico, 01120 | |
| OCA-MIRC | |
| Monterrey, Mexico, 64020 | |
| Hospital Santa Engracia-CIMA | |
| Garza Garcia, Mexico, 66260 | |
| Mexico, Durango | |
| Instituto Mexicano de Investigacion | |
| Mexico City, Durango, Mexico, 06700 | |
| Mexico, Nuevo Leon | |
| Hospital Universitario Dr Jose E Gonzalez | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| Poland | |
| Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego | |
| Lodz, Poland, 90-153 | |
| Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED | |
| Warsaw, Poland, 03 580 | |
| Centrum Leczenia Chorob cywilizacyjnych | |
| Warszawa, Poland, 02 777 | |
| Poland, POL | |
| NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny | |
| Bialystok, POL, Poland, 15-435 | |
| Instytut Centrum Zdrowia (009) Matki Polki | |
| Lodz, POL, Poland, 93-338 | |
| Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego | |
| Krakow, POL, Poland, 31 501 | |
| Spzital Kolejowy imm Wlodzimierza Roeflera | |
| Pruszkow, POL, Poland, 05-800 | |
| Klinika Endocrinologii Diabetologii I | |
| Bialystock, POL, Poland, 15-276 | |
| Russian Federation | |
| NI Central Clinical Hospital of RAS | |
| Moscow, Russian Federation, 117 593 | |
| Russian Federation, RUS | |
| NHI Kemerovo Regional Clinical Hospital | |
| Kemerovo, RUS, Russian Federation, 650061 | |
| NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky | |
| Moscow, RUS, Russian Federation, 129110 | |
| Central Medical Sanitary Unit #122 | |
| St Petersburg, RUS, Russian Federation, 194291 | |
| NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense | |
| Moscow, RUS, Russian Federation, 105229 | |
| MHI Clinical Hospital for Emergency Care na NV Soloviev | |
| Yaroslavl, RUS, Russian Federation, 150003 | |
| St Petersburg NHI Municipal Multi-Speciality Hospital # 2 | |
| St. Petersburg, RUS, Russian Federation, 194354 | |
| NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70 | |
| Moscow, RUS, Russian Federation, 111399 | |
| TUV Medico-Military Academy | |
| St Petersburg, RUS, Russian Federation, 198013 | |
| St Petersburg NHI City Polytclinic #77 City Diabetological Center #4 | |
| St Petersburg, RUS, Russian Federation, 193012 | |
| NHI Yaroslavl Regional Clinical Hospital | |
| Yaroslavl, RUS, Russian Federation, 150062 | |
| NI Endrocrinological Research Centre of RAMS In patient replacing technologies department | |
| Moscow, RUS, Russian Federation, 115478 | |
| NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital | |
| Smolensk, RUS, Russian Federation, 214018 | |
| Spain | |
| Hospital Ramon y Cajal | |
| Madrid, Spain, 28034 | |
| Hospital Clinic I Provincial | |
| Barcelona, Spain, 08036 | |
| Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia | |
| Sabadell, Spain, 08208 | |
| Hospital Universitario de la Princessa | |
| Madrid, Spain, 28006 | |
| Spain, Andalucia | |
| Complejo Hospitalario Nuestra Senora de Valme | |
| Sevilla, Andalucia, Spain, 41014 | |
| Ukraine | |
| Public Institution City Policlinic #20 Odessa | |
| Odessa, Ukraine, 65114 | |
| Outpatient Clinic of Family Physician "Rusanovka" | |
| Kiev, Ukraine, 02147 | |
| Ukraine, UKR | |
| Railway Clinical Hospital on Donetsk Station | |
| Donetsk, UKR, Ukraine, 83114 | |
| Ukr Scientifically Practical Centre of Endocrine Surgery | |
| Kiev, UKR, Ukraine, 2175 | |
| Donetsk State Medical University | |
| Donetsk, UKR, Ukraine, 83003 | |
| Institute of Endocrinology and Metabolism | |
| Kiev, UKR, Ukraine, 04114 | |
| Odessa Reg. Clinical Hosp Outpatient Department | |
| Odessa, UKR, Ukraine, 65025 | |
| Odessa State Medical University Dept of Gen Practice and Med Rehab | |
| Odessa, UKR, Ukraine, 65009 | |
| Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin) | |
| Donetsk, UKR, Ukraine, 83099 | |
| Bukovinian State Medical University Dept of Clinical Immun | |
| Chernivtsy, UKR, Ukraine, 58022 | |
| Dniepropetrovsh State Medical Academy | |
| Dniepropetrovsk, UKR, Ukraine, 49023 | |
| Vinnitsa State Medical University | |
| Vinnitsa, UKR, Ukraine, 21010 | |
| Chair Family Med of National Med University | |
| Kiev, UKR, Ukraine, 04050 | |
| Odessa State Med Dept of Family Med and Gen Practice | |
| Odessa, UKR, Ukraine, 65039 | |
| Study Director: | Anders Boss | Mannkind Corporation |
More Information
| Responsible Party: | MannKind Corporation ( Anders Boss, MD, MFPM, Chief Medical Officer ) |
| Study ID Numbers: | MKC-TI-103 |
| Study First Received: | May 31, 2006 |
| Last Updated: | October 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00332488 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Metformin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |
