RecruitingPhase 3NCT06772168

Evaluate the Efficacy and Safety of CMG190303 in Patients With Type 2 Diabetes and Dyslipidemia

A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of CMG190303 in Patients With Type 2 Diabetes and Dyslipidemia

Sponsor

CMG Pharmaceutical Co. Ltd

Enrollment

240 participants

Start Date

Apr 19, 2024

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Dyslipidemia

Summary

The goal of this clinical trial is to learn if drug CMG190303 to treat Type 2 Diabetes and Dyslipidemia in adults. It will also learn about the safety of CMG190303. The main questions it aims to answer are: -Primary Objectives: 1. To compare the change in HbA1c from baseline to 24 weeks between CMG190303 and Rosuvastatin 2. To compare the change in LDL-C from baseline to 24 weeks between CMG190303 and Dapagliflozin

Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination drug called CMG190303 (which combines dapagliflozin, a diabetes drug, with rosuvastatin, a cholesterol-lowering drug) in South Korean adults who have both type 2 diabetes and high cholesterol (dyslipidemia). **You may be eligible if...** - You are 19–80 years old and live in South Korea - You have both type 2 diabetes and dyslipidemia (high cholesterol) - You are currently on stable diabetes medication (such as metformin) for at least 6 weeks **You may NOT be eligible if...** - You have a known allergy to dapagliflozin or rosuvastatin - You are pregnant, breastfeeding, or of childbearing potential and unwilling to use contraception - You have serious kidney, liver, or heart disease - You have type 1 diabetes or diabetic ketoacidosis 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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Interventions

DRUGCMG190303(Dapagliflozin/Rosuvastatin)

0-8 week: Dapagliflozin 10mg and Rosuvastatin 5mg 8-16 week: Dapagliflozin 10mg and Rosuvastatin 10mg 16-24 week: Dapagliflozin 10mg and Rosuvastatin 20mg

DRUGComparator 1: Dapagliflozin/Rosuvastatin placebo

0-24 week: Dapagliflozin 10mg and Rosuvastatin placebo

DRUGRosuvastatin/Dapagliflozin placebo

0-8 week: Dapagliflozin placebo and Rosuvastatin 5mg 8-16 week: Dapagliflozin placebo and Rosuvastatin 10mg 16-24 week: Dapagliflozin placebo and Rosuvastatin 20mg

Locations(24)

Hallym university sungsim medical center

Anyang, South Korea

Buchon sejong hospital

Buchon, South Korea

Inje university heaundea paik hospital

Busan, South Korea

Soonchunhyang cheonan university hospital

Cheonan, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Daejeon eulji medical center, eulji university

Daejeon, South Korea

Myongji Hospital

Goyang-si, South Korea

Hanyang University Medical Center

Guri-si, South Korea

Chosun University Hospital

Gwangju, South Korea

Wonkwang university hospital

Iksan, South Korea

Inha university hospital

Inchon, South Korea

Chonbuk National University Hospital

Jeonju, South Korea

Bundang CHA medical center

Seongnam, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Nowon eulji medical center, eulji university

Seoul, South Korea

Korea University ANAM Hospital

Seoul, South Korea

Severance hospital

Seoul, South Korea

Kyung hee university hospital at gangdong

Seoul, South Korea

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

Hallym university gangnam medical center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

Wonju serverance christian hospital

Wŏnju, South Korea

Yongin Severance Hospital

Yongin-si, South Korea

View Full Details on ClinicalTrials.gov

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