Study Phase 3

A Randomized, Double-Blind, 5-Arm, Parallel-Group, 26-Week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in Combination With Metformin as Initial Combination Therapy in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

Trial Information

Generic NameCanagliflozinProduct NameINVOKANA®Therapeutic AreaNutritional and Metabolic DiseasesEnrollment1186% Female52%% White81.6%
Product ClassSodium-Glucose Co-Transporter 2 (SGLT2) InhibitorSponsor Protocol Number28431754DIA3011Data PartnerJohnson & JohnsonCondition StudiedDiabetes Mellitus, Type 2Mean/Median Age (Years)54.9

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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