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

Phase 3

Recruiting

• Conditions: Type 2 Diabetes; Dyslipidemia
• Interventions: Drug: CMG190303(Dapagliflozin/Rosuvastatin); Drug: Rosuvastatin/Dapagliflozin placebo

• Registration Number: NCT06772168
• Lead Sponsor: CMG Pharmaceutical Co. Ltd

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-19
• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-11-04
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CMG190303(Dapagliflozin/Rosuvastatin)	CMG190303(Dapagliflozin/Rosuvastatin)	-
Comparator 2: Rosuvastatin/Dapagliflozin placebo	Rosuvastatin/Dapagliflozin placebo	-

Primary Outcome Measures

Name	Time	Method
To compare the change in HbA1c (%) from baseline to 24 weeks between the dapagliflozin and rosuvastatin combination group and the rosuvastatin monotherapy group	From enrollment to the end of treatment at 24 weeks
To compare the percentage change in LDL-C from baseline to 24 weeks between the dapagliflozin and rosuvastatin combination group and the dapagliflozin monotherapy group	From enrollment to the end of treatment at 24 weeks

Secondary Outcome Measures

Name	Time	Method
To compare the change in HbA1c (%) from baseline to 24 weeks between the dapagliflozin and rosuvastatin combination group and the dapagliflozin monotherapy group	From enrollment to the end of treatment at 24 weeks
The percentage change in LDL-C from baseline to 8, 16, and 24 weeks after administration of the investigational medicinal product	From enrollment to the end of treatment at 24 weeks
The proportion of subjects achieving LDL-C target levels by cardiovascular risk category from baseline to 8, 16, and 24 weeks after administration of the investigational medicinal product	From enrollment to 8, 16, and 24 weeks
The change in fasting plasma glucose (FPG) (mg/dL) from baseline to 8, 16, and 24 weeks after administration of the investigational medicinal product	From enrollment to 8, 16, and 24 weeks
The percentage change in the following lipid parameters from baseline to 8, 16, and 24 weeks after administration of the investigational medicinal product:	From enrollment to 8, 16, and 24 weeks	Total cholesterol (TC) (mg/dL) Triglyceride (TG) (mg/dL) HDL-C (mg/dL) Non-HDL-C (mg/dL) ApoB (mg/dL), ApoAI (mg/dL), ApoB/ApoAI Ratio
The change in HbA1c (%) from baseline to 24 weeks in the rosuvastatin monotherapy group	From enrollment to the end of treatment at 24 weeks

Trial Locations

Locations (21)

Buchon sejong hospital; 🇰🇷 Buchon, Korea, Republic of

Inje university heaundea paik hospital; 🇰🇷 Busan, Korea, Republic of

Soonchunhyang cheonan university hospital; 🇰🇷 Cheonan, Korea, Republic of

Hallym university gangnam medical center; 🇰🇷 Seoul, Korea, Republic of

Hallym university sungsim medical center; 🇰🇷 Anyang, Korea, Republic of

Daejeon eulji medical center, eulji university; 🇰🇷 Daejeon, Korea, Republic of

Hanyang University Medical Center; 🇰🇷 Guri, Korea, Republic of

Chosun University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Wonkwang university hospital; 🇰🇷 Iksan, Korea, Republic of

Inha university hospital; 🇰🇷 Inchon, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Bundang CHA medical center; 🇰🇷 Seongnam, Korea, Republic of

Yongin Severance Hospital; 🇰🇷 Yongin-si, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Nowon eulji medical center, eulji university; 🇰🇷 Seoul, Korea, Republic of

Korea University ANAM Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance hospital; 🇰🇷 Seoul, Korea, Republic of

Kyung hee university hospital at gangdong; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Wonju serverance christian hospital; 🇰🇷 Wonju, Korea, Republic of