Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5559
Source ID: NCT03088670
Associated Drug: Gosogliptin
Title: Efficacy and Safety of Gosogliptin as Monotherapy and in Combination With Metformin vs. Vildagliptin as Monotherapy and in Combination With Metformin in Drug-naive Type 2 Diabetic Patients.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Gosogliptin|DRUG: Vildagliptin|DRUG: Metformin
Outcome Measures: Primary: Mean change of HbA1c, Gosogliptin treatment group vs. Vildagliptin treatment group, at Weeks 12 and 36 from baseline | Secondary: HbA1c level of ≤7%, Percent of patients who reach the target HbA1c, at Weeks 12 and 36 from baseline|Hypoglycemic episodes, Incidence of hypoglycemic episodes during the monotherapy and in combination with Metformin, up to 36 week|Fasting plasma glucose, Change of fasting plasma glucose from baseline, at Weeks 12 and 36|Change of Body Mass, Change of Body Mass from baseline, at Weeks 12 and 36|Adverse event, AE rate, up to 40 week
Sponsor/Collaborators: Sponsor: SatRx LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 299
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-04-23
Completion Date: 2014-10-03
Results First Posted:
Last Update Posted: 2017-03-23
Locations: Non-state healthcare Organization "Road Clinical Hospital at the station Chelyabinsk Open Joint Stock Company" Russian Railways, Chelyabinsk, 454048, Russian Federation|State Budget Healthcare Institution of Moscow "Endocrinology Dispensary", Moscow, 119034, Russian Federation|SEI HPE "First Moscow State Medical University n.a. I.M. Sechenov of Ministry of Health and Social Development of the Russian Federation", Chair of faculty therapy #2 based at SHI of Moscow "City clinical hospital #61", Moscow, 119048, Russian Federation|State Budget Educational Institution higher professional education "1st Moscow State Medical University n.a. I.M. Sechenov of the Ministry of Healthcare of Russian Federation", Moscow, 119435, Russian Federation|Federal State Institution "Clinical Hospital № 1" of the Office of the President of the Russian Federation, Moscow, 121352, Russian Federation|State Budget Healthcare Institution of Moscow city "City Clinical Hospital # 71 by the Department of Healthcare in Moscow", Moscow, 121374, Russian Federation|State Budget Educational Institution of higher professional education "1st Moscow State Medical University n.a. I.M. Sechenov of the Ministry of Healthcare of Russian Federation" based on Endocrinology department of Hospital № 67 n.a L A Vorohobova, Moscow, 123423, Russian Federation|SEI APE "Russian Medical Academy of Postgraduate Education of Roszdrav", Chair of endocrinology and diabetology with course of endocrine surgery based at FSI "Central Clinical hospital of civil aviation", Moscow, 125367, Russian Federation|State budgetary institution "Nizhny Novgorod Regional Clinical Hospital n.a Semashko, Nizhny Novgorod, 603126, Russian Federation|State Health Care Institution "Perm Regional Hospital for War Veterans", Perm, 614097, Russian Federation|State Educational Institution of Higher Professional Education "Perm State Medical Academy n.a. academician EA Wagner's "Ministry of Health of the Russian Federation on the basis of Department of Endocrinology Regional Clinical Hospital, Perm, 614990, Russian Federation|SHI "Republic Hospital n.a. V.A. Baranov", Petrozavodsk, 185019, Russian Federation|State budgetary institution of Ryazan region "City Clinical Hospital № 11", Ryazan, 390037, Russian Federation|St. Petersburg State healthcare institution "City Outpatient Clinic #37", Saint Petersburg, 191119, Russian Federation|FSHI "Clinical Hospital #122 n.a. L.G. Sokolov of FMBA of Russia", Internal medicine department, Saint Petersburg, 194291, Russian Federation|State Health Care Institution Leningrad Regional Hospital, Saint Petersburg, 194291, Russian Federation|Autonomous Noncommercial Organization "Medical Centre "XXI сentury", Saint Petersburg, 194354, Russian Federation|St. Petersburg State healthcare institution "City Hospital of Saint Martyr Elizaveta", Saint Petersburg, 195257, Russian Federation|FSMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the Ministry of Defence of the Russian Federation, 1st Internal medicine Chair of advanced training, Saint Petersburg, 198013, Russian Federation|"Diabetes Center "LLC, Samara, 443041, Russian Federation|State Budget Educational Institution higher professional education "Saratov State Medical University n.a. V.I. Razumovsky" of the Ministry of Healthcare of Russian Federation based on Clinical Hospital n.a S.R. Mirotvortsev, Saratov, , 410054, Russian Federation|Municipal health care institution "City polyclinic №20, Saratov, 410018, Russian Federation|SBEI HPE "Smolensk State Medical Academy" of the Ministry of Health and Social Development of the Russian Federation, Center of clinical research of diagnostic and medicinal products, Chair of clinical pharmacology, Smolensk, 214019, Russian Federation|State budget educational institution of higher education "Smolensk State Medical Academy," of Ministry of Health and Social Development of the Russian Federation on the basis of sanatorium SSMA, Smolensk, 214019, Russian Federation|State autonomous healthcare institution of Yaroslavl Region "Сlinical hospital for emergency medical care n. a. N.V. Solovyov", Yaroslavl, 150003, Russian Federation|Municipal clinical health institution Health Service Novo-Yaroslavl Oil Refinery, Yaroslavl, 150023, Russian Federation|SHI of Yaroslavl region "Regional Clinical Hospital", Endocrinology department, Yaroslavl, 150062, Russian Federation
URL: https://clinicaltrials.gov/show/NCT03088670

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