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Clinical Trial Details

Trial ID: L6692
Source ID: NCT01238978
Associated Drug: Vildagliptin
Title: Phase 4 Study in the Elderly Patients With T2DM
Acronym: GLYCEMIA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Elderly
Interventions: DRUG: Vildagliptin|DRUG: "Usual Care"
Outcome Measures: Primary: Percent of patients in each of the two treatment groups presenting no hypoglycemia (confirmed events with SMBG and severe episodes) after 24 wk of randomized therapy added to their ongoing metformin background therapy., 24 weeks | Secondary: Percent of patients reaching their therapeutic goal, 24 weeks|Percent of patients with success of primary EP (no confirmed/severe hypoglycemia) and reaching their therapeutic goal, 24 weeks|Glycemic control assessed by A1C, and the mean of 6 Points self-monitoring of blood glucose (SMBG) at baseline and after 24 weeks., 24 weeks
Sponsor/Collaborators: Sponsor: Novartis
Gender: ALL
Age: OLDER_ADULT
Phases: PHASE4
Enrollment: 46
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-10
Completion Date: 2011-12
Results First Posted:
Last Update Posted: 2017-02-23
Locations: Novartis Investigative Site, Armentieres, 59208, France|Novartis Investigative Site, Brest, 29200, France|Novartis Investigative Site, Caen, 14000, France|Novartis Investigative Site, Creil, 60100, France|Novartis Investigative Site #2, Paris, 75012, France|Novartis Investigative Site, Paris, 75020, France|Novartis Investigative Site, Pau, 64000, France|Novartis Investigative Site, St Jean de la Ruelle, 45140, France|Novartis Investigative Site, Strasbourg, 67000, France|Novartis Investigative Site, Strasbourg, France|Novartis Investigative Site, Toulouse, 31200, France|Novartis Investigative Site, Tours, 37000, France|Novartis Investigative Site, Venissieux, 69200, France|Novartis Investigative Site #2, Venissieux, France|Novartis Investigative Site, Versailles, 78000, France
URL: https://clinicaltrials.gov/show/NCT01238978

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