Study Phase 2

A Randomized Phase 2, Double-blind, Placebo-controlled, Treat-to-Target, Parallel-group, 3-arm, Multicenter Study to Assess the Efficacy and Safety of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Subjects With Type 1 Diabetes Mellitus

Trial Information

Generic NameCanagliflozinProduct NameINVOKANA®Therapeutic AreaAlimentary Tract and MetabolismProduct ClassDrugs Used in DiabetesPharmacological SubgroupBlood Glucose Lowering Drugs, Excluding InsulinsChemical SubgroupSodium-Glucose Co-Transporter 2 (SGLT2) InhibitorsCondition StudiedDiabetes Mellitus, Type 1
Sponsor Protocol Number28431754DIA2004Enrollment352Data PartnerJohnson & Johnson% Female43.9%Mean/Median Age (Years)42.3% WhiteN/A

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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