RecruitingPhase 3NCT05466643

A Study to Investigate the Effect of DWP16001 as add-on Therapy to Drug A in Patients With Type 2 Diabetes Mellitus

A Multicenter, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of DWP16001 as add-on Therapy to Drug A, With or Without Antihyperglycemic Drugs, in Patients With Type 2 Diabetes Mellitus

Sponsor

Daewoong Pharmaceutical Co. LTD.

Enrollment

240 participants

Start Date

Mar 17, 2023

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Mellitus

Summary

A multicenter, randomized, placebo-controlled clinical trial, double-blind, parallel-group

Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing DWP16001, a new blood sugar-lowering drug, as an add-on to a standard diabetes medication ("Drug A") in adults with Type 2 diabetes whose blood sugar is not well controlled. Researchers want to see if DWP16001 safely improves blood sugar levels. **You may be eligible if...** - You are 19–80 years old with Type 2 diabetes - You have been on a stable dose of the study's standard background medication for at least 8 weeks - Your blood sugar (HbA1c) is in the range specified by the study - You can manage up to 2 additional oral diabetes drugs **You may NOT be eligible if...** - You have Type 1 diabetes - You have serious kidney or liver problems - You are pregnant or breastfeeding - You have had a recent cardiovascular event (heart attack or stroke) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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