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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

NCT07619833 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2026-06-02

No results posted yet for this study

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

Conditions

  • T2DM (Type 2 Diabetes Mellitus)

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

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619833 on ClinicalTrials.gov