NCT04356742

Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Dapagliflozin When Added to Ongoing Metformin and Evogliptin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the addition of dapagliflozin in the treatment of type 2 diabetes with metformin and evogliptin combination therapy. Half of subjects will receive dapagliflozin, metformin and evogliptin, while the other half will receive placebo, metformin and evogliptin.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10mg	Dapagliflozin 10mg, orally, once daily, up to 24weeks
DRUG	Placebo	Dapagliflozin Placebo, orally, once daily, up to 24weeks
DRUG	Evogliptin 5mg	Evogliptin 5mg, orally, once daily for background therapy
DRUG	Metformin≥1000mg	Metformin≥1000mg, orally, daily for background therapy

Timeline

• Start date: 2020-05-26
• Primary completion: 2022-02-23
• Completion: 2022-02-23
• First posted: 2020-04-22
• Last updated: 2022-03-22

Locations

1 site across 1 country: South Korea