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NOT YET RECRUITING
NCT07619833
PHASE3

To Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus

Sponsor: Daewoong Pharmaceutical Co. LTD.

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and safety of initial combination therapy with DWP16001 and DWC202518 compared to DWP16001 monotherapy and DWC202518 monotherapy in patients with Type 2 Diabetes Mellitus

Official title: A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

510

Start Date

2026-06

Completion Date

2027-11

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DRUG

DWP16001

DWP16001 0.3mg, Tablets, Orally, Once daily

DRUG

DWC202518

DWC202518, Tablets, Orally, Once daily

DRUG

Placebo of DWP16001

DWP16001 placebo-matching tablets

DRUG

Placebo of DWC202518

DWC202518 placebo-matching tablets

Locations (1)

Kangbuk Samsung Hospital

Seoul, South Korea