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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Intervention / Treatment: Drug: DWP16001; Drug: DWC202518; Drug: Placebo of DWC202518; Drug: Placebo of DWP16001

• Study Type: Interventional
• Enrollment (Estimated): 510
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yoonhye Jeong; Phone Number: 82-2-550-8016; Email: yoonhye@daewoong.co.kr

Study Locations

• South Korea
  • Seoul, South Korea
    • Kangbuk Samsung Hospital
    • Contact: Cheol-Young Park; Phone Number: 82-2-550-8016; Email: yoonhye@daewoong.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able and willing to cooperate and participate in this clinical study after understanding the study explanation, and capable of voluntarily signing the written informed consent form before any assessments are performed.
2. Male or female adult aged ≥18 and ≤80 years. Note: The minimum legal age of adult dependent on local regulations. The legal age of adult in Korea is 19 years, while in Indonesia, it is 18 years.
3. Have been diagnosed with T2DM based on American Diabetes Association (ADA) guidelines (2025) before screening.

4. Participants must meet one of the following conditions at Visit 1 (Screening):

   • Have an HbA1c ≥7.5% and ≤11% at Visit 1 (Screening) and either have never taken oral anti-diabetic medication since diagnosis or have not taken any oral anti-diabetic medication within 12 weeks prior to screening.
   • Have an HbA1c ≥6.5% and ≤10.5% at Visit 1 (Screening) and are currently taking one type of oral anti-diabetic medication at screening.

   Note: The HbA1c level at Visit 1 can be measured by the local laboratory.

5. Have an FPG <15 mmol/L (270 mg/dL), as measured by local laboratory at Visit 1.

6. Participants must meet all the following conditions at Visit 2 (Baseline):

   • Have an HbA1c ≥7.5% and ≤11%, as measured by the central laboratory at Visit 1-1.
   • Have an FPG <15 mmol/L (270 mg/dL), as measured by central laboratory at Visit 1-1.
7. Have a BMI ≥20 kg/m2 and ≤45 kg/m2 at screening.
8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening. WOCBP and their partners must use highly effective, medically accepted contraception to prevent pregnancy and must not have pregnancy or fertility plans throughout the study and for at least 4 weeks after the last dose of study medication
9. Male participants must agree to use highly effective, medically accepted contraception and refrain from donating sperm throughout the study and for at least 4 weeks after the last dose of study medication

Exclusion Criteria:

• Type 1 diabetes mellitus, congenital diabetes, secondary diabetes, or history of diabetic ketoacidosis, diabetic coma, or precoma
• Severe diabetes-related complications, including proliferative diabetic retinopathy, advanced nephropathy, or severe diabetic neuropathy
• Clinically significant renal disease, severe gastrointestinal disease or surgery affecting gastrointestinal absorption, pancreatitis, clinically significant urinary/genital infections, dehydration requiring treatment, or uncontrolled thyroid disease
• Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening, including myocardial infarction, unstable angina, stroke, clinically significant arrhythmia requiring treatment, or New York Heart Association (NYHA) class III-IV heart failure
• Active or untreated malignancy, or clinically significant malignancy within the previous 5 years (except adequately treated localized skin cancers or in situ carcinomas)
• Hematologic conditions that may interfere with HbA1c measurement
• Clinically significant endocrine disorders affecting glucose metabolism
• Known or suspected hypersensitivity to study treatment or related products
• Screening laboratory abnormalities including:

ㆍ Fasting C-peptide ≤0.60 ng/mL ㆍ Triglycerides >500 mg/dL ㆍ eGFR <60 mL/min/1.73m² ㆍ AST or ALT ≥3× upper limit of normal (ULN), or total bilirubin ≥2× ULN

• Positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection meeting protocol-defined criteria
• Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg)
• Prior use of prohibited antidiabetic therapies, including prior antidiabetic combination therapy, thiazolidinediones within 12 weeks, or GLP-1 receptor agonists or insulin within 6 months before screening
• Use of weight-loss medications within 3 months prior to screening or between screening and baseline
• Use of systemic corticosteroids at pharmacologic doses within 1 month prior to screening or between screening and baseline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination Group	Drug: DWP16001; DWP16001 0.3mg, Tablets, Orally, Once daily; Drug: DWC202518; DWC202518, Tablets, Orally, Once daily
Experimental: DWP16001 monotherapy Group	Drug: DWP16001; DWP16001 0.3mg, Tablets, Orally, Once daily; Drug: Placebo of DWC202518; DWC202518 placebo-matching tablets
Experimental: DWC202518 monotherapy Group	Drug: DWC202518; DWC202518, Tablets, Orally, Once daily; Drug: Placebo of DWP16001; DWP16001 placebo-matching tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c at Week 24 from Baseline after Randomization	6 months

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Enavogliflozin
• Other Study ID Numbers: DW_DWP16001311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No