At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Double-Blind, Active-Controlled , Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin 5mg Co-administered With Dapagliflozin 5mg Compared to Saxagliptin 5mg or Dapagliflozin 5mg All Given as Add-on Therapy to Metformin inPatients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Alone
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin, Placebo for Dapagliflozin, and 2 other interventions for Type 2 Diabetes Mellitus and Inadequate Glycaemic Control. Completed, enrolled 905 participants across 110 sites in 6 countries.
Detailed Summary
The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.
Study Details
Timeline
Interventions
5mg, orally, Green, plain, diamond-shaped, film-coated tablet
Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet
5mg, orally, Plain, yellow, biconvex, round, film-coated tablet
Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet