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Clinical Trial Details

Trial ID: L3188
Source ID: NCT01224366
Associated Drug: Vildagliptin
Title: Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Vildagliptin|DRUG: Placebo
Outcome Measures: Primary: HbA1c reduction, 24 weeks | Secondary: HbA1c reduction in subpopulation treated with insulin and with metformin, 24 weeks|HbA1c reduction in subpopulation treated with insulin and without metformin, 24 weeks|Reduction in FPG (overall and subpopulations), 24 weeks|Responder rates (overall and subpopulations), 24 weeks|Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations), 24 weeks
Sponsor/Collaborators: Sponsor: Novartis
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 448
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-09
Completion Date: 2011-10
Results First Posted:
Last Update Posted: 2017-02-23
Locations: Novartis Investigative Site, Box Hill, Australia|Novartis Investigative Site, Heidelberg Heights, Australia|Novartis Investigative Site, Parkville, Australia|Novartis Investigative Site #1, Wollongong, Australia|Novartis Investigative Site #2, Wollongong, Australia|Novartis Investigative Site, Bonheiden, Belgium|Novartis Investigative Site, Edegem, Belgium|Novartis Investigative Site, Genk, Belgium|Novartis Investigative Site, La Louviere, Belgium|Novartis Investigative Site, Ronse, Belgium|Novartis Investigative Site #1, Ostrava, Czech Republic|Novartis Investigative Site #2, Ostrava, Czech Republic|Novartis Investigative Site #3, Ostrava, Czech Republic|Novartis Investigative Site, Asslar, Germany|Novartis Investigative Site, Bensheim, Germany|Novartis Investigative Site, Berlin, Germany|Novartis Investigative Site, Einbeck, Germany|Novartis Investigative Site #1, Hamburg, Germany|Novartis Investigative Site #2, Hamburg, Germany|Novartis Investigative Site #3, Hamburg, Germany|Novartis Investigative Site #4, Hamburg, Germany|Novartis Investigative Site, Hannover, Germany|Novartis Investigative Site #1, Kassel, Germany|Novartis Investigative Site #2, Kassel, Germany|Novartis Investigative Site, Munchen, Germany|Novartis Investigative Site, Neubukow, Germany|Novartis Investigative Site, Saarlouis, Germany|Novartis Investigative Site, Tubingen, Germany|Novartis Investigative Site #1, Guatemala City, Guatemala|Novartis Investigative Site #2, Guatemala City, Guatemala|Novartis Investigative Site #3, Guatemala City, Guatemala|Novartis Investigative Site #4, Guatemala City, Guatemala|Novartis Investigative Site #5, Guatemala City, Guatemala|Novartis Investigative Site #1, Hong Kong, Hong Kong|Novartis Investigative Site #2, Hong Kong, Hong Kong|Novartis Investigative Site #1, Budapest, Hungary|Novartis Investigative Site #2, Budapest, Hungary|Novartis Investigative Site, Dunaujvaros, Hungary|Novartis Investigative Site, Nyiregyhaza, Hungary|Novartis Investigative Site, Szeged, Hungary|Novartis Investigative Site, Indore, India|Novartis Investigative Site, Jaipur, India|Novartis Investigative Site, Karnal, India|Novartis Investigative Site #2, Mumbai, India|Novartis Investigative Site #1, Mumbia, India|Novartis Investigative Site #1, Nagpur, India|Novartis Investigative Site #2, Nagpur, India|Novartis Investigative Site, Nasik, India|Novartis Investigative Site #1, Trivandrum, India|Novartis Investigative Site #2, Trivandrum, India|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, Banska Bystrica, Slovakia|Novartis Investigative Site #1, Bratislava, Slovakia|Novartis Investigative Site #2, Bratislava, Slovakia|Novartis Investigative Site #3, Bratislava, Slovakia|Novartis Investigative Site #1, Kosice, Slovakia|Novartis Investigative Site #2, Kosice, Slovakia|Novartis Investigative Site, Presov, Slovakia|Novartis Investigative Site, Sturovo, Slovakia|Novartis Investigative Site, Carmarthen, United Kingdom|Novartis Investigative Site #1, Glasgow, United Kingdom|Novartis Investigative Site #2, Glasgow, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01224366

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