drugset / Trial / NCT03714594

Effects of Dapagliflozin+Saxagliptin in Addition to Metformin v/s Saxagliptin or Dapagliflozin in Patients With DM2.

NCT03714594

Phase 2 Completed 48 enrolled University of Pisa
RandomizedParallel-groupDouble-blindTreatment

Summary

A phase IV, randomized, double-blind, single center pilot study in subjects with type 2 diabetes poorly controlled with metformin therapy will be randomized to receive, on top of metformin: saxagliptin (5 mg/day) and dapagliflozin (10 mg/day) (Group 1);saxagliptin (5 mg/day) and placebo (Group 2); dapagliflozin (10 mg/day) and placebo (Group 3) for 4 weeks.

Timeline

Start
2018-07-24
Primary completion
2022-08-31
Completion
2022-08-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dapagliflozin Small molecule 10 mg
Comparator SAXAGLIPTIN ANHYDROUS Small molecule 5 mg