A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2011
INTERVENTION: investigational material(s) Generic name etc : Dapagliflozin INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : 5mg, matching placebo for 10mg, oral dose Generic name etc : Dapagliflozin INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : 10mg, matching placebo for 5mg, oral dose control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : matching placebo for 5mg, matching placebo for 10mg, oral dose CONDITION: Diabetes Mellitus INCLUSION CRITERIA: ‐ Provision of informed consent prior to any study specific procedures ‐ Men or women age 20 years old or more (Either gender needs to be 40% or higher of total number of treated subjects) ‐ Diagnosed with type2 DM
Epistemonikos ID: 5f8d80b10405e40983db0e7cf36479c3d633514e
First added on: Aug 26, 2024