Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Technosphere Insulin Drug: Metformin & Secretagogues Drug: Technosphere Insulin & Metformin |
| Phase | Phase 3 |
| Sponsor | Mannkind Corporation |
| Responsible Party | Mannkind Corporation |
| ClinicalTrials.gov Identifier | NCT00332488 |
| First Received | May 31, 2006 |
| Last Updated | October 1, 2009 |
| Last verified | October 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 31, 2006 |
|---|---|
| Last Updated Date | October 1, 2009 |
| Start Date | December 2004 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Change from baseline to Week 12 in glycated hemoglobin [Time Frame: 12 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Change in HbA1c from baseline [Time Frame: 24 weeks] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes |
|---|---|
| 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. |
| Brief Summary | to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Technosphere Insulin Inhalation, 15U/30U, prandial Drug: Metformin & Secretagogues Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations. Drug: Technosphere Insulin & Metformin Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 547 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | March 2008 |
| Eligibility Criteria | Inclusion Criteria: - Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months - Stable regimen of metformin for > or = to 1000mg/day 9or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks. - Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria - HbA1c >or= to 7.5% and < or= to 11.0% - BMI < or = to 40kg/m2. - FEV1> or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70% Exclusion Criteria: - Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues within the preceding 12 weeks - Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects - History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings - Evidence of serious complications of diabetes (e.g. autonomic neuropathy) |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Argentina, Brazil, Canada, Chile, Czech Republic, Mexico, Poland, Russian Federation, Spain, Ukraine |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00332488 |
|---|---|
| Other Study ID Numbers | MKC-TI-103 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Mannkind Corporation |
| Study Sponsor | Mannkind Corporation |
| Collaborators | Not Provided |
| Investigators | Study Director: Anders Boss Mannkind Corporation |
| Verification Date | October 2009 |
Locations[ + expand ][ + ]
| Radiant Research-Birmingham | Birmingham, Alabama, United States, 35209 |
|---|---|
| Parkway Medical Center | Birmingham, Alabama, United States, 35215 |
| Redpoint Research | Phoenix, Arizona, United States, 85029 |
| Arizona Center for Clinical Research | Phoenix, Arizona, United States, 85032 |
| International Clinical Research Network | Chula Vista, California, United States, 91911 |
| 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 |
| Chase Medical Research, LLC | Waterbury, Connecticut, United States, 06708 |
| Center for Diabetes & Endocrine Care | Hollywood, Florida, United States, 33021 |
| International Research Associates LLC | Miami, Florida, United States, 33156 |
| 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 |
| James A Dicke MDPA | Towson, Maryland, United States, 21204 |
| East Coast Clinical Research Inc | Haverhill, Massachusetts, United States, 01830 |
| Wayne State University | Detroit, Michigan, United States, 48201 |
| Michigan Institute of Medicine | Livonia, Michigan, United States, 48152 |
| 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 |
| Creighton Diabetes Center | Omaha, Nebraska, United States, 68131 |
| Lovelace Scientific Resources (Albuquerque) | Albuquerque, New Mexico, United States, 87108 |
| Winthrop University Hospital | Mineola, New York, United States, 11501 |
| North Shore Diabetes and Endocrine Associates | New Hyde Park, New York, United States, 11042 |
| Metrolina Internal Medicine | Charlotte, North Carolina, United States, 28204 |
| Sensenbrenner Primary Care | Charlotte, North Carolina, United States, 28277 |
| Charlotte Clinical Research Inc | Charlotte, North Carolina, United States, 28211 |
| Duke Medical Center | Durham, North Carolina, United States, 27710 |
| Providence Health Partners - Center of Clinical Research | Dayton, Ohio, United States, 45439 |
| Dayton Clinical Research | Dayton, Ohio, United States, 45406 |
| Radiant Research | Portland, Oregon, United States, 97239 |
| Upstate Pharmaceutical Research | Greenville, South Carolina, United States, 29615 |
| Collierville Medical Specialists | Collierville, Tennessee, United States, 38017 |
| Memphis Internal Medicine (Kathawala) | Memphis, Tennessee, United States, 38119 |
| GoodLife Medical Center PLLC | Memphis, Tennessee, United States, 38120 |
| Baylor Endocrine Center | Dallas, Texas, United States, 75246 |
| Covenant Clinic Research | San Antonio, Texas, United States, 78229 |
| SAM Clinical Research Center | San Antonio, Texas, United States, 78229 |
| Quality Assurance Research Center Inc | San Antonio, Texas, United States, 78205 |
| Clinical Trials of Texas Inc | San Antonio, Texas, United States, 78229 |
| Diabetes & Glandular Disease Research Assoc PA | San Antonio, Texas, United States, 78229 |
| Cedar Research | Tacoma, Washington, United States, 98405 |
| Hospital Interzonal de Agudos Pedro Fiorito | Avellaneda, Buenos Aires, Argentina, B1870ARG |
| 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 |
| 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 |
| 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 |
| Hospital do Rim e Hipertensao | Sao Paulo, Brazil, 04025-011 |
| CPClin-Centro de Pesquisas Clinicas | Sao Paulo, Brazil, 01244-030 |
| UNIFRSP | Sao Paulo, Brazil, 04020-050 |
| Quest Clinical Trials | Markham, Ontario, Canada, L6B 1A1 |
| Lifestyle Metabolism Center | Oakville, Ontario, Canada, L6H 3P1 |
| Lifestyle Metabolism Center | Thornhill, Ontario, Canada, L4J 8L7 |
| Lifestyle Metabolism Center | Toronto, Ontario, Canada, M4R 2G4 |
| Trial Management Group Inc (Henein | Toronto, Ontario, Canada, M4T 1N5 |
| Unimedico Management | Richmond Hill, Canada, L4C 9M7 |
| Hospital Padre Alberto Hurtado | Santiago, Region Metropolitana, Chile |
| Hospital del Salvador | Santiago, Chile |
| Instituto de Informacion de Tramiento y Educacion en Salud | Santiago, Chile |
| Hospital Clinico Pontificia Universidad Catolica de Chile | Santiago, Chile |
| Diabetologicka a interni ambulance | 707 02 Ostrava-Kuncice, CZE, Czech Republic, 70702 |
| 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 ambulance (Chmura) | Ostrava, Czech Republic, 70200 |
| Interní a diabetologická Outpatient | Ostrava, Czech Republic, 70900 |
| Endokrinologicky ustav | Praha 1, Czech Republic, 11694 |
| II interni klinika FN Kralovske Vinohrady | Praha 10, Czech Republic, 10034 |
| 3rd Medical Department General Faculty Hospital | Praha 2, Czech Republic, 12801 |
| Instituto Mexicano de Investigacion | Mexico City, Durango, Mexico, 06700 |
| Hospital Universitario Dr Jose E Gonzalez | Monterrey, Nuevo Leon, Mexico, 64460 |
| Hospital Santa Engracia-CIMA | Garza Garcia, Mexico, 66260 |
| Centro de Estudios en Diabetes | Mexico City, Mexico, 01120 |
| Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio | Mexico City, Mexico, 06726 |
| OCA-MIRC | Monterrey, Mexico, 64020 |
| Klinika Endocrinologii Diabetologii I | Bialystock, POL, Poland, 15-276 |
| NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny | Bialystok, POL, Poland, 15-435 |
| Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego | Krakow, POL, Poland, 31 501 |
| Instytut Centrum Zdrowia (009) Matki Polki | Lodz, POL, Poland, 93-338 |
| Spzital Kolejowy imm Wlodzimierza Roeflera | Pruszkow, POL, Poland, 05-800 |
| 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 |
| NHI Kemerovo Regional Clinical Hospital | Kemerovo, RUS, Russian Federation, 650061 |
| NI Endrocrinological Research Centre of RAMS In patient replacing technologies department | Moscow, RUS, Russian Federation, 115478 |
| NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky | Moscow, RUS, Russian Federation, 129110 |
| NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense | Moscow, RUS, Russian Federation, 105229 |
| NEI HPE Moscow State University of Medicine and Dentistry of FAHSD City Clinical Hospital #70 | Moscow, RUS, Russian Federation, 111399 |
| NEI HPE Smolensk State Medical Academy of FAHSD RNHI Smolensk Regional Clinical Hospital | Smolensk, RUS, Russian Federation, 214018 |
| Central Medical Sanitary Unit #122 | St Petersburg, RUS, Russian Federation, 194291 |
| St Petersburg NHI City Polytclinic #77 City Diabetological Center #4 | St Petersburg, RUS, Russian Federation, 193012 |
| TUV Medico-Military Academy | St Petersburg, RUS, Russian Federation, 198013 |
| St Petersburg NHI Municipal Multi-Speciality Hospital # 2 | St. Petersburg, RUS, Russian Federation, 194354 |
| NHI Yaroslavl Regional Clinical Hospital | Yaroslavl, RUS, Russian Federation, 150062 |
| MHI Clinical Hospital for Emergency Care na NV Soloviev | Yaroslavl, RUS, Russian Federation, 150003 |
| NI Central Clinical Hospital of RAS | Moscow, Russian Federation, 117 593 |
| Complejo Hospitalario Nuestra Senora de Valme | Sevilla, Andalucia, Spain, 41014 |
| Hospital Clinic I Provincial | Barcelona, Spain, 08036 |
| Hospital Ramon y Cajal | Madrid, Spain, 28034 |
| Hospital Universitario de la Princessa | Madrid, Spain, 28006 |
| Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia | Sabadell, Spain, 08208 |
| Bukovinian State Medical University Dept of Clinical Immun | Chernivtsy, UKR, Ukraine, 58022 |
| Dniepropetrovsh State Medical Academy | Dniepropetrovsk, UKR, Ukraine, 49023 |
| Railway Clinical Hospital on Donetsk Station | Donetsk, UKR, Ukraine, 83114 |
| Donetsk State Medical University | Donetsk, UKR, Ukraine, 83003 |
| Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin) | Donetsk, UKR, Ukraine, 83099 |
| Institute of Endocrinology and Metabolism | Kiev, UKR, Ukraine, 04114 |
| Chair Family Med of National Med University | Kiev, UKR, Ukraine, 04050 |
| Ukr Scientifically Practical Centre of Endocrine Surgery | Kiev, UKR, Ukraine, 2175 |
| 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 |
| Odessa State Med Dept of Family Med and Gen Practice | Odessa, UKR, Ukraine, 65039 |
| Vinnitsa State Medical University | Vinnitsa, UKR, Ukraine, 21010 |
| Outpatient Clinic of Family Physician "Rusanovka" | Kiev, Ukraine, 02147 |
| Public Institution City Policlinic #20 Odessa | Odessa, Ukraine, 65114 |