Clinical Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2

Phase 3 Completed 230 enrolled Daewon Pharmaceutical Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy

Timeline

Start: 2022-10-27
Primary completion: 2023-12-04
Completion: 2024-06-19

Outcome

Met primary endpoint

paper The least square mean differences [95% CI] versus the placebo were -0.54% [-0.78, -0.29] for E10 group and -0.61% [-0.85, -0.36] for E25 group PMID 41883295 ↗

paper both p < 0.0001 PMID 41883295 ↗

Publications

Lim S, Kim TN, Mok JO, Chung CH, Hwang YC, Cho HC, Won JC, Jeon E, Kang ES, Lee KY, Kim CH, Kwak SH, Park CY, Park KS, Kim SY, Lee JH, Lee SH, Cho DH, Kwon HS, Han KA. Efficacy and Safety of Fixed-Dose Combinations of Sitagliptin and Empagliflozin as Add-On to Metformin in Korean Patients With Type 2 Diabetes: A Randomised, Double-Blind, Multi-Centre, Placebo-Controlled, Phase III Trial. Diabetes Obes Metab. 2026 Jun;28(6):4847-4859. doi: 10.1111/dom.70669. Epub 2026 Mar 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Empagliflozin	Small molecule	10 mg	—
Subject	Empagliflozin	Small molecule	25 mg	—
Subject	Sitagliptin	Small molecule	100 mg	—