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
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-13
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-28
• 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 enrollment to the end of treatment at 24 weeks	from baseline to 24 weeks between the dapagliflozin and rosuvastatin combination group and the rosuvastatin monotherapy group
To compare the percentage change in LDL-C	From enrollment to the end of treatment at 24 weeks	from baseline to 24 weeks between the dapagliflozin and rosuvastatin combination group and the dapagliflozin monotherapy group

Secondary Outcome Measures

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

Trial Locations

Locations (24)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Myongji Hospital; 🇰🇷 Goyang-si, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of

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

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

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

Soonchunhyang cheonan university hospital; 🇰🇷 Cheonan, 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

Scroll for more (14 remaining)