Actively Recruiting
Evaluate the Efficacy and Safety of CMG190303 in Patients With Type 2 Diabetes and Dyslipidemia
Led by CMG Pharmaceutical Co. Ltd · Updated on 2026-01-15
240
Participants Needed
24
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluate the Efficacy and Safety of CMG190303 in Patients With Type 2 Diabetes and Dyslipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 to 80 years living in South Korea
- Diagnosed with Type 2 Diabetes and Dyslipidemia
- On stable metformin monotherapy (≥1,000 mg/day) for at least 6 weeks prior to screening or on dual oral diabetes therapy with stable metformin dose for at least 1 week
- HbA1c between 7.0% and 10.5% for metformin monotherapy or between 6.5% and 10% for dual therapy at screening
- Fasting Plasma Glucose ≤ 270 mg/dL at screening
- For patients without recent dyslipidemia treatment: LDL-C between 100 and 250 mg/dL and triglycerides ≤ 400 mg/dL
- For patients with recent dyslipidemia treatment: on stable statin monotherapy for at least 6 weeks prior to screening
- Willing and able to provide informed consent
You will not qualify if you...
- Known allergy to dapagliflozin, rosuvastatin, or any study drug components
- Pregnant, breastfeeding, or unwilling to use effective contraception
- Body mass index less than 15 or greater than 40 kg/m2
- Type 1 diabetes, secondary diabetes, or severe diabetes complications
- Metabolic acidosis such as diabetic ketoacidosis
- Recent acute arterial disease or severe heart conditions within specified time frames
- Uncontrolled high or low blood pressure
- Uncontrolled thyroid dysfunction or history of muscle disorders including rhabdomyolysis
- Severe kidney or liver impairment
- History of drug addiction or major psychiatric illness within past year
- Recent pancreatitis, infections of urinary or reproductive systems, or urinary disorders
- History of gastrointestinal surgery or disorders affecting drug absorption
- Certain genetic disorders affecting sugar metabolism
- Cancer within past 5 years except specific successfully treated cases
- Use of insulin injections, weight control drugs, cyclosporin, or systemic steroids within specified recent periods
- Scheduled for examinations requiring iodine contrast or contraindicated for metformin
- Use of prohibited medications during the study
- Participation in other clinical trials with investigational products within past 3 months
- Any condition considered by the investigator to make participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 24 locations
1
Hallym university sungsim medical center
Anyang, South Korea, 14068
Actively Recruiting
2
Buchon sejong hospital
Buchon, South Korea, 14754
Actively Recruiting
3
Inje university heaundea paik hospital
Busan, South Korea, 48108
Actively Recruiting
4
Soonchunhyang cheonan university hospital
Cheonan, South Korea, 31151
Actively Recruiting
5
Keimyung University Dongsan Medical Center
Daegu, South Korea, 42601
Actively Recruiting
6
Daejeon eulji medical center, eulji university
Daejeon, South Korea, 35233
Actively Recruiting
7
Myongji Hospital
Goyang-si, South Korea, 10475
Actively Recruiting
8
Hanyang University Medical Center
Guri-si, South Korea, 11923
Actively Recruiting
9
Chosun University Hospital
Gwangju, South Korea, 61453
Actively Recruiting
10
Wonkwang university hospital
Iksan, South Korea, 54538
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11
Inha university hospital
Inchon, South Korea, 22332
Actively Recruiting
12
Chonbuk National University Hospital
Jeonju, South Korea, 54907
Actively Recruiting
13
Bundang CHA medical center
Seongnam, South Korea, 13496
Actively Recruiting
14
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
15
Nowon eulji medical center, eulji university
Seoul, South Korea, 01830
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16
Korea University ANAM Hospital
Seoul, South Korea, 02841
Actively Recruiting
17
Severance hospital
Seoul, South Korea, 03722
Actively Recruiting
18
Kyung hee university hospital at gangdong
Seoul, South Korea, 05278
Actively Recruiting
19
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
20
Hallym university gangnam medical center
Seoul, South Korea, 07441
Actively Recruiting
21
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
22
Ajou University Hospital
Suwon, South Korea, 16499
Actively Recruiting
23
Wonju serverance christian hospital
Wŏnju, South Korea, 26426
Actively Recruiting
24
Yongin Severance Hospital
Yongin-si, South Korea, 16995
Actively Recruiting
Research Team
C
CMG pharm Co., Ltd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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