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.

PHASE3CompletedINTERVENTIONAL
Enrollment

299

Participants

Timeline

Start Date

April 23, 2013

Primary Completion Date

March 30, 2014

Study Completion Date

October 3, 2014

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Gosogliptin

20 mg per day, dose titration to 30 mg per day at Week 4 as required Administration: orally

DRUG

Vildagliptin

50 mg per day, dose titration to 100 mg per day at Week 4 as required (50 mg twice a day) Administration: orally

DRUG

Metformin

"1000 mg per day starting Week 12 (500 mg twice a day), dose titration to 2000 mg per day at Week 16 as required (1000 mg twice a day).~Administration: orally"

Trial Locations (27)

119034

"State Budget Healthcare Institution of Moscow Endocrinology Dispensary", Moscow

119048

"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

119435

"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

121352

"Federal State Institution Clinical Hospital № 1 of the Office of the President of the Russian Federation", Moscow

121374

"State Budget Healthcare Institution of Moscow city City Clinical Hospital # 71 by the Department of Healthcare in Moscow", Moscow

123423

"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

125367

"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

150003

"State autonomous healthcare institution of Yaroslavl Region Сlinical hospital for emergency medical care n. a. N.V. Solovyov", Yaroslavl

150023

Municipal clinical health institution Health Service Novo-Yaroslavl Oil Refinery, Yaroslavl

150062

"SHI of Yaroslavl region Regional Clinical Hospital, Endocrinology department", Yaroslavl

185019

"SHI Republic Hospital n.a. V.A. Baranov", Petrozavodsk

191119

"St. Petersburg State healthcare institution City Outpatient Clinic #37", Saint Petersburg

194291

"FSHI Clinical Hospital #122 n.a. L.G. Sokolov of FMBA of Russia, Internal medicine department", Saint Petersburg

State Health Care Institution Leningrad Regional Hospital, Saint Petersburg

194354

"Autonomous Noncommercial Organization Medical Centre XXI сentury", Saint Petersburg

195257

"St. Petersburg State healthcare institution City Hospital of Saint Martyr Elizaveta", Saint Petersburg

198013

"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

214019

"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

"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

390037

"State budgetary institution of Ryazan region City Clinical Hospital № 11", Ryazan

410018

"Municipal health care institution City polyclinic №20", Saratov

443041

"Diabetes Center LLC", Samara

454048

"Non-state healthcare Organization Road Clinical Hospital at the station Chelyabinsk Open Joint Stock Company Russian Railways", Chelyabinsk

603126

"State budgetary institution Nizhny Novgorod Regional Clinical Hospital n.a Semashko", Nizhny Novgorod

614097

"State Health Care Institution Perm Regional Hospital for War Veterans", Perm

614990

"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

, 410054

"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

All Listed Sponsors
lead

SatRx LLC

INDUSTRY

NCT03088670 - 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. | Biotech Hunter | Biotech Hunter