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Clinical Trial Details

Trial ID: L3469
Source ID: NCT01233622
Associated Drug: Vildagliptin
Title: Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride
Acronym: Vildagliptin
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Vildagliptin|DRUG: Placebo
Outcome Measures: Primary: HbA1c Reduction, 24 weeks | Secondary: FPG reduction, 24 weeks|Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs), 24 weeks|Responder Rate, 24 weeks
Sponsor/Collaborators: Sponsor: Novartis
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: 2010-10
Completion Date: 2011-11
Results First Posted:
Last Update Posted: 2017-02-23
Locations: Novartis Investigative Site, Box Hill, Australia|Novartis Investigative Site, Heidelberg, Australia|Novartis Investigative Site, Parkville, Australia|Novartis Investigative Site, St. Leonards, Australia|Novartis Investigative Site, Anderbeck, Germany|Novartis Investigative Site #1, Berlin, Germany|Novartis Investigative Site #2, Berlin, Germany|Novartis Investigative Site #3, Berlin, Germany|Novartis Investigative Site #4, Berlin, Germany|Novartis Investigative Site, Hamburg, Germany|Novartis Investigative Site, Hildesheim, Germany|Novartis Investigative Site, Sangerhausen, Germany|Novartis Investigative Site, Budapest, Hungary|Novartis Investigative Site, Erd, Hungary|Novartis Investigative Site, Torokbalint, Hungary|Novartis Investigative Site, Bergamo, Italy|Novartis Investigative Site, Cosenza, Italy|Novartis Investigative Site, Milano, Italy|Novartis Investigative Site, Padova, Italy|Novartis Investigative Site, Pisa, Italy|Novartis Investigative Site #1, Roma, Italy|Novartis Investigative Site #2, Roma, Italy|Novartis Investigative Site, Torino, Italy|Novartis Investigative Site, Bundang, Korea, Republic of|Novartis Investigative Site #1, Seoul, Korea, Republic of|Novartis Investigative Site #2, Seoul, Korea, Republic of|Novartis Investigative Site #3, Seoul, Korea, Republic of|Novartis Investigative Site, Suwon, Korea, Republic of|Novartis Investigative Site #1, Aguascalientes, Mexico|Novartis Investigative Site #2, Aguascalientes, Mexico|Novartis Investigative Site #3, Aguascalientes, Mexico|Novartis Investigative Site #1, Durango, Mexico|Novartis Investigative Site #2, Durango, Mexico|Novartis Investigative Site #3, Durango, Mexico|Novartis Investigative Site #1, Guadalajara, Mexico|Novartis Investigative Site #2, Guadalajara, Mexico|Novartis Investigative Site #3, Guadalajara, Mexico|Novartis Investigative Site #4, Guadalajara, Mexico|Novartis Investigative Site #5, Guadalajara, Mexico|Novartis Investigative Site, Mexico, Mexico|Novartis Investigative Site #1, Pachuca, Mexico|Novartis Investigative Site #2, Pachuca, Mexico|Novartis Investigative Site #3, Pachuca, Mexico|Novartis Investigative Site, Manila, Philippines|Novartis Investigative Site #1, Quezon City, Philippines|Novartis Investigative Site #2, Quezon City, Philippines|Novartis Investigative Site, Alba-Iulia, Romania|Novartis Investigative Site, Bucharest, Romania|Novartis Investigative Site #1, Oradea, Romania|Novartis Investigative Site #2, Oradea, Romania|Novartis Investigative Site, Targu-Mures, Romania|Novartis Investigative Site, Changhua, Taiwan|Novartis Investigative Site, Taichung, Taiwan|Novartis Investigative Site, Taipei, Taiwan|Novartis Investigative Site, Yongkang, Taiwan
URL: https://clinicaltrials.gov/show/NCT01233622

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