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Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus

NCT06141980 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2023-11-21

No results posted yet for this study

Summary

The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period.

At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.

The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

Conditions

  • T2DM (Type 2 Diabetes Mellitus)

Interventions

DRUG

DWP16001 0.3 mg

DWP16001 0.3mg, Tablets, Orally, Once daily

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Principal Investigators

  • Soo Lim, MD, PH.D · Seoul National University Bundang Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2025-09-30
Completion
2025-09-30

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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 NCT06141980 on ClinicalTrials.gov