drugset / Trial / NCT02681094

A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes

NCT02681094

Phase 3 Completed 905 enrolled AstraZeneca
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2016-02-26
Primary completion
2017-07-15
Completion
2017-07-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dapagliflozin Small molecule 5 mg Oral
Comparator SAXAGLIPTIN ANHYDROUS Small molecule 5 mg Oral