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

Phase 3 Completed 283 enrolled Dong-A ST Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2020-01-02
Primary completion: 2021-06-28
Completion: 2021-12-08

Outcome

Met primary endpoint

paper Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 PMID 37750183 ↗

Publications

Moon JS, Park IR, Kim HJ, Chung CH, Won KC, Han KA, Park CY, Won JC, Kim DJ, Koh GP, Kim ES, Yu JM, Hong EG, Lee CB, Yoon KH. Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension. Diabetes Metab J. 2023 Nov;47(6):808-817. doi: 10.4093/dmj.2022.0387. Epub 2023 Sep 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evogliptin	Small molecule	5 mg	Oral
Background	Dapagliflozin	Small molecule	10 mg	Oral
Background	Metformin	Small molecule	1000 mg	—