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Clinical Trial Details

Trial ID: L7302
Source ID: NCT01257451
Associated Drug: Vildagliptin
Title: Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Vildagliptin|DRUG: Placebo
Outcome Measures: Primary: To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo, 24 weeks | Secondary: To evaluate the safety and tolerability of vildagliptin in elderly patients with T2DM who are drug-naive or inadequately controlled with oral antidiabetic drugs (OADs) including physical exam, vital sign, hematology, chemistry and electrocardiogram., 24 weeks|To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo, 24 weeks|To assess the responder rates of patients treated with vildagliptin as compared to placebo, 24 weeks
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: OLDER_ADULT
Phases: PHASE3
Enrollment: 431
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-12
Completion Date: 2012-03
Results First Posted:
Last Update Posted: 2012-12-18
Locations: Novartis Investigative Site, Buizingen, 1501, Belgium|Novartis Investigative Site, De Pinte, 9840, Belgium|Novartis Investigative Site, Genk, 3600, Belgium|Novartis Investigative Site, Mouscron, 7700, Belgium|Novartis Investigative Site, Nazareth, 9810, Belgium|Novartis Investigative Site, Oostham, 3945, Belgium|Novartis Investigative Site, Wichelen, 9260, Belgium|Novartis Investigative Site, Blagoevgrad, 2700, Bulgaria|Novartis Investigative Site, Dimitrovgrad, 6400, Bulgaria|Novartis Investigative Site, Pleven, 5800, Bulgaria|Novartis Investigative Site, Plovdiv, 4001, Bulgaria|Novartis Investigative Site, Sofia, 1431, Bulgaria|Novartis Investigative Site, Varna, 9002, Bulgaria|Novartis Investigative Site, Lahti, Suomi, 15110, Finland|Novartis Investigative Site, Helsinki, 00180, Finland|Novartis Investigative Site, Oulu, FIN-90100, Finland|Novartis Investigative Site, Bamberg, 96050, Germany|Novartis Investigative Site, Beckum, 59269, Germany|Novartis Investigative Site, Berlin, 10115, Germany|Novartis Investigative Site, Falkensee, 14612, Germany|Novartis Investigative Site, Lichtenfels, 96215, Germany|Novartis Investigative Site, Lutherstadt Eisleben, 06295, Germany|Novartis Investigative Site, Magdeburg, 39112, Germany|Novartis Investigative Site, Mammendorf, 82291, Germany|Novartis Investigative Site, Münster, 48143, Germany|Novartis Investigative Site, Potsdam, 14469, Germany|Novartis Investigative Site, Sulzbach-Rosenberg, 92237, Germany|Novartis Investigative Site, Völlkingen, 66333, Germany|Novartis Investigative Site, Wetter, 58300, Germany|Novartis Investigative Site, Bratislava, Slovak Republic, 811 02, Slovakia|Novartis Investigative Site, Lubochna, Slovak Republic, 03491, Slovakia|Novartis Investigative Site, Kosice, 040 22, Slovakia|Novartis Investigative Site, Levice, 934 01, Slovakia|Novartis Investigative Site, Nové Zámky, 940 01, Slovakia|Novartis Investigative Site, Pie¿¿any, 92101, Slovakia|Novartis Investigative Site, Ruzomberok, 034 01, Slovakia|Novartis Investigative Site, Sanlúcar de Barrameda, Andalucía, 11540, Spain|Novartis Investigative Site, Centelles, Barcelona, 08540, Spain|Novartis Investigative Site, Alzira, Comunidad Valenciana, 46600, Spain|Novartis Investigative Site, Alicante, 03114, Spain|Novartis Investigative Site, Truro, Cornwall, TR1 3LJ, United Kingdom|Novartis Investigative Site, Birmingham, B9 5SS, United Kingdom|Novartis Investigative Site, Exeter, EX2 5DW, United Kingdom|Novartis Investigative Site, Stevenage, SG1 4AB, United Kingdom|Novartis Investigative Site, Wiltshire, SN15 2SB, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01257451

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