Diabetes Mellitus, Type 2 Clinical Trial
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.
| NCT number | NCT00332488 |
| Other study ID # | MKC-TI-103 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | May 31, 2006 |
| Last updated | October 9, 2014 |
| Start date | December 2004 |
| Verified date | October 2014 |
| Source | Mannkind Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue
| Status | Completed |
| Enrollment | 547 |
| Est. completion date | |
| Est. primary completion date | March 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 or 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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Interzonal de Agudos Pedro Fiorito | Avellaneda | Buenos Aires |
| Argentina | Centro Endocrinologic Tiempo | Buenos Aires | |
| Argentina | CIMeL | Buenos Aires | |
| Argentina | Cons Asoc de Endocrinologia | Buenos Aires | |
| Argentina | Hospital Italiano de Buenos Aires | Buenos Aires | |
| Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul |
| Brazil | Hospital Sao Lucas da PUCRS | Porto Alegre | Rio Grande do Sul |
| Brazil | Ccbr Brasil Centro de Analises e Pesquisas Clinicas Ltda | Rio de Janeiro | |
| Brazil | Hospital Guilherme Alvaro | Santos | |
| Brazil | CPClin-Centro de Pesquisas Clinicas | Sao Paulo | |
| Brazil | Hospital do Rim e Hipertensao | Sao Paulo | |
| Brazil | Instituto de Pesquisa Clinica e Medicina Avancada | Sao Paulo | |
| Brazil | UNIFRSP | Sao Paulo | |
| Canada | Quest Clinical Trials | Markham | Ontario |
| Canada | Lifestyle Metabolism Center | Oakville | Ontario |
| Canada | Unimedico Management | Richmond Hill | |
| Canada | Lifestyle Metabolism Center | Thornhill | Ontario |
| Canada | Lifestyle Metabolism Center | Toronto | Ontario |
| Canada | Trial Management Group Inc (Henein | Toronto | Ontario |
| Chile | Hospital Clinico Pontificia Universidad Catolica de Chile | Santiago | |
| Chile | Hospital del Salvador | Santiago | |
| Chile | Hospital Padre Alberto Hurtado | Santiago | Region Metropolitana |
| Chile | Instituto de Informacion de Tramiento y Educacion en Salud | Santiago | |
| Czech Republic | Diabetologicka ambulance (Chmura) | Ostrava | |
| Czech Republic | Interní a diabetologická Outpatient | Ostrava | |
| Czech Republic | Diabetologicka a interni ambulance | Ostrava-Kuncice | CZE |
| Czech Republic | Institute for Clinical and Exp Medicine | Prague 4 | CZE |
| Czech Republic | University Hospital Na Bulovce | Prague 8 | CZE |
| Czech Republic | Endokrinologicky ustav | Praha 1 | |
| Czech Republic | II interni klinika FN Kralovske Vinohrady | Praha 10 | |
| Czech Republic | 3rd Medical Department General Faculty Hospital | Praha 2 | |
| Mexico | Hospital Santa Engracia-CIMA | Garza Garcia | |
| Mexico | Centro de Estudios en Diabetes | Mexico City | |
| Mexico | Hospital General de Mexico Servicio EndocrinologiaJefe Del Servicio | Mexico City | |
| Mexico | Instituto Mexicano de Investigacion | Mexico City | Durango |
| Mexico | Hospital Universitario Dr Jose E Gonzalez | Monterrey | Nuevo Leon |
| Mexico | OCA-MIRC | Monterrey | |
| Poland | Klinika Endocrinologii Diabetologii I | Bialystock | POL |
| Poland | NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny | Bialystok | POL |
| Poland | Katedra I Klinika Chorob Metabolicznych Collegium Medicum Uniwersytety Jagiellonskiego | Krakow | POL |
| Poland | Instytut Centrum Zdrowia (009) Matki Polki | Lodz | POL |
| Poland | Oddzial Kliniczny Diabetologii (009) Kliniczny nr 1 im Norberta Barlickiego Uniwersytety Meycznego | Lodz | |
| Poland | Spzital Kolejowy imm Wlodzimierza Roeflera | Pruszkow | POL |
| Poland | Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED | Warsaw | |
| Poland | Centrum Leczenia Chorob cywilizacyjnych | Warszawa | |
| Russian Federation | NHI Kemerovo Regional Clinical Hospital | Kemerovo | 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 | |
| Russian Federation | NI Endrocrinological Research Centre of RAMS In patient replacing technologies department | Moscow | RUS |
| Russian Federation | NI Moscow Regional Scientific Research Clinical Institute na MF Vladimirsky | Moscow | RUS |
| Russian Federation | NI Principal Military Clinical Hospital n a academician N.N. Burdenko of the Ministry of Defense | Moscow | 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 | 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 | MHI Clinical Hospital for Emergency Care na NV Soloviev | Yaroslavl | RUS |
| Russian Federation | NHI Yaroslavl Regional Clinical Hospital | Yaroslavl | RUS |
| Spain | Hospital Clinic I Provincial | Barcelona | |
| Spain | Hospital Ramon y Cajal | Madrid | |
| Spain | Hospital Universitario de la Princessa | Madrid | |
| Spain | Corporacion Sanitaria Parc Tauli Unidad de Endocrinologia | Sabadell | |
| Spain | Complejo Hospitalario Nuestra Senora de Valme | Sevilla | Andalucia |
| Ukraine | Bukovinian State Medical University Dept of Clinical Immun | Chernivtsy | UKR |
| Ukraine | Dniepropetrovsh State Medical Academy | Dniepropetrovsk | UKR |
| Ukraine | Donetsk State Medical University | Donetsk | UKR |
| Ukraine | Donetsk State Medical University (Chair of Immun Allergogoly & Endocrin) | Donetsk | UKR |
| Ukraine | Railway Clinical Hospital on Donetsk Station | Donetsk | UKR |
| Ukraine | Chair Family Med of National Med University | Kiev | UKR |
| Ukraine | Institute of Endocrinology and Metabolism | Kiev | UKR |
| Ukraine | Outpatient Clinic of Family Physician "Rusanovka" | Kiev | |
| Ukraine | Ukr Scientifically Practical Centre of Endocrine Surgery | Kiev | UKR |
| Ukraine | Odessa Reg. Clinical Hosp Outpatient Department | Odessa | UKR |
| Ukraine | Odessa State Med Dept of Family Med and Gen Practice | Odessa | UKR |
| Ukraine | Odessa State Medical University Dept of Gen Practice and Med Rehab | Odessa | UKR |
| Ukraine | Public Institution City Policlinic #20 Odessa | Odessa | |
| Ukraine | Vinnitsa State Medical University | Vinnitsa | UKR |
| United States | Lovelace Scientific Resources (Albuquerque) | Albuquerque | New Mexico |
| United States | Parkway Medical Center | Birmingham | Alabama |
| United States | Radiant Research-Birmingham | Birmingham | Alabama |
| United States | Charlotte Clinical Research Inc | Charlotte | North Carolina |
| United States | Metrolina Internal Medicine | 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 | Collierville Medical Specialists | Collierville | Tennessee |
| United States | Baylor Endocrine Center | Dallas | Texas |
| United States | Dayton Clinical Research | Dayton | Ohio |
| United States | Providence Health Partners - Center of Clinical Research | Dayton | Ohio |
| United States | Creekside Endocrine Associates | Denver | Colorado |
| United States | Jennifer Hone MD | Denver | Colorado |
| United States | National Jewish Medical & Research Center | Denver | Colorado |
| United States | Wayne State University | Detroit | Michigan |
| United States | Duke Medical Center | Durham | North Carolina |
| United States | Upstate Pharmaceutical Research | Greenville | South Carolina |
| United States | East Coast Clinical Research Inc | Haverhill | Massachusetts |
| United States | Center for Diabetes & Endocrine Care | Hollywood | Florida |
| United States | Michigan Institute of Medicine | Livonia | Michigan |
| United States | GoodLife Medical Center PLLC | Memphis | Tennessee |
| United States | Memphis Internal Medicine (Kathawala) | Memphis | Tennessee |
| United States | International Research Associates LLC | Miami | Florida |
| United States | Winthrop University Hospital | Mineola | New York |
| United States | North Shore Diabetes and Endocrine Associates | New Hyde Park | New York |
| United States | Creighton Diabetes Center | Omaha | Nebraska |
| United States | Arizona Center for Clinical Research | Phoenix | Arizona |
| United States | Redpoint Research | Phoenix | Arizona |
| United States | Radiant Research | Portland | Oregon |
| 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 | Clintell Inc | Skokie | Illinois |
| United States | Clayton Medical Research | St Louis | Missouri |
| United States | Raidant Research-St Louis | St Louis | Missouri |
| United States | Washington University School of Medicine | St. Louis | Missouri |
| United States | Cedar Research | Tacoma | Washington |
| United States | James A Dicke MDPA | Towson | Maryland |
| United States | Chase Medical Research, LLC | Waterbury | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Mannkind Corporation |
United States, Argentina, Brazil, Canada, Chile, Czech Republic, Mexico, Poland, Russian Federation, Spain, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue | Baseline to Week 12 | No | |
| Secondary | Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue | (Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue) | Baseline to Week 12 | No |
| Secondary | Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment) | Week 24 | No |
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