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Clinical Trial Details

Trial ID: L7365
Source ID: NCT00728351
Associated Drug: Vildagliptin + Metformin
Title: Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: vildagliptin + metformin|DRUG: metformin
Outcome Measures: Primary: HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy, 24 weeks | Secondary: FPG reduction, 24 weeks|Safety and tolerability, 24 weeks|Body weight change from baseline, 24 weeks|Changes in the fasting lipid profile, 24 weeks
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 317
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-06
Completion Date:
Results First Posted:
Last Update Posted: 2020-12-19
Locations: Pine Bluff, Arkansas, 71603, United States|Long Beach, California, 90806, United States|Denver, Colorado, 80209, United States|Bangor, Maine, 04401, United States|Billings, Montana, 59102, United States|Novartis Investigative Site, New Brunswick, New Jersey, 08903, United States|Trenton, New Jersey, 08611, United States|Wilmington, North Carolina, 28409, United States|Oklahoma City, Oklahoma, 73104, United States|Uniontown, Pennsylvania, United States|Taylors, South Carolina, 29687, United States|Houston, Texas, 77023, United States|Houston, Texas, 77074, United States|Houston, Texas, 77081, United States|Norfolk, Virginia, 23510, United States|Wenatchee, Washington, 98801, United States|Cabinet d'Endocrinologie-Maladies Métaboliques, Annecy, 74000, France|Service Endocrinologic & Metabolisme, Paris, 75013, France|Polycliniques des minguettes, Venissieux, 69200, France|Hausärztliche Praxis, Aschaffenburg, 63739, Germany|Klinische Forschung Berlin Mitte GmbH, Berlin, 10117, Germany|AVK, Berlin, 12157, Germany|Gemeinschaftspraxis, Celle, 29221, Germany|Malteser KM, Duisburg, 42259, Germany|Untertrintroper Hausarztzentrum, Essen, 45359, Germany|Gefrees, 95482, Germany|Diabeteszentrum Billstedt/Horn, Hamburg, 22119, Germany|Diabetologische Schwerpunktpraxis, Hamburg, 22119, Germany|St. Elisabeth Krankenhaus Leipzig, Leipzig, 04229, Germany|Diabetes-Schwerpunktpraxis Studienambulanz, Leipzig, 04257, Germany|Institut für Diabetes-forschung Münster, Münster, 48145, Germany|Praxis Dr. Alawi, Saarlouis, 66740, Germany|DDT, Siegen, 57072, Germany|Diabetologische Schwerpunktpraxis, Sinsheim, 74889, Germany|Praxis, Wangen, 88239, Germany|Synexus Magyarorszag, Budapest, 1036, Hungary|Uzsoki Hospital, Budapest, 1145, Hungary|Budapest, Hungary|Europ-Med Orvosi Szolgaltato Kft, Budaörs, 2040, Hungary|Kenezy Hospital, Debrecen, Hungary|Gyngyosi Korhaz Kft, Gyongyos, 3200, Hungary|Petz Aladar County, Györ, 9024, Hungary|Selye Janos Korhaz es Rendelointezet, Komarom, 2900, Hungary|DIAPED Kft., MRC, Meggyesalja U., 122, Hungary|Josa Andras Teaching Hospital, Nyiregyhaza, 4400, Hungary|Vas Megyei Markuscvszky Lajos Korhaz, Szombathely, 9700, Hungary|Zala County Hospital, Zalaegerszeg, Hungary|NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok, Bialystok, 15-435, Poland|Gdanska Poradnia Cukrzycowa, Gdansk, 80-858, Poland|Gabinet Kardiologiczny Mediplus, Gdynia, 81-423, Poland|NZOZ "Esculap" S.C., Gniewkowo, 88-140, Poland|SZPZOZ Szpital Zachodni im. Jana Pawla II, Grodzisk Mazowiecki, 05-825, Poland|NZOZ Terapia Optima, Katowice, 40-752, Poland|Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy, Leczyca, 99-100, Poland|Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca, Leczyca, 99-100, Poland|Instytut Cantrum Zdrowia Matki Polki, Lodz, 93-338, Poland|NZOZ Special-Med, Lublin, 20-044, Poland|Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza, Poznan, 60-569, Poland|Lecznica Prosen-SMO NZOZ, Warszawa, 01-231, Poland|Centrum Leczenia Chorob Cywilizacyjnych, Warszawa, 02-777, Poland|NZCZ Regionalna Poradnia Diabetologiczna, Wroclaw, 50-127, Poland|Samodzielny Publiczny Szpital Kliniczny Nr 1, Wroclaw, 50-367, Poland|Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM, Zabrze, 41-800, Poland
URL: https://clinicaltrials.gov/show/NCT00728351

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D432 Vildagliptin small molecule DB04876 Details
D089 Metformin small molecule DB00331 Details