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A Multicenter, Randomized, Placebo-controlled, Double-blind Trial Evaluating the Efficacy and Safety of CMG190303 in Adults With Type 2 Diabetes and Dyslipidemia
Led by CMG Pharmaceutical Co. Ltd · Updated on 2026-01-15
240
Participants Needed
24
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug CMG190303 for treating adults with Type 2 Diabetes and Dyslipidemia. This phase III trial aims to compare how CMG190303 affects blood sugar control (measured by HbA1c) and cholesterol levels (measured by LDL-C) over 24 weeks, compared to two other treatments: Rosuvastatin and Dapagliflozin. The study also monitors the safety of CMG190303 throughout the treatment period. Participants are randomly assigned to one of three groups: those receiving CMG190303 (a combination of Dapagliflozin and Rosuvastatin with doses increasing over 24 weeks), a group receiving Dapagliflozin with a Rosuvastatin placebo, or a group receiving Rosuvastatin with a Dapagliflozin placebo. The dosing schedule adjusts every 8 weeks with increasing amounts for both drugs in the CMG190303 group, while the placebo groups maintain consistent dosing. The trial is double-blinded, meaning neither participants nor researchers know which treatment is given. During the study, participants will have regular assessments to measure their HbA1c and LDL-C levels at various points up to 24 weeks. Additional blood tests will monitor fasting plasma glucose and other lipid parameters at 8, 16, and 24 weeks. Medication adherence is tracked, and safety monitoring is ongoing. The total participation duration is 24 weeks of treatment, during which researchers collect data to understand the drug's effects and safety in adults with these conditions.
CONDITIONS
Brief 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 between 19 and 80 years
- Diagnosed with Type 2 Diabetes and Dyslipidemia
- On stable metformin monotherapy (at least 1,000 mg/day) for specified durations or on stable dual oral diabetes therapy
- HbA1c levels between 7.0% and 10.5% for metformin monotherapy, or between 6.5% and 10% for dual therapy
- Fasting plasma glucose (FPG) of 270 mg/dL or less
- LDL-C between 100 mg/dL and 250 mg/dL, and triglycerides (TG) 400 mg/dL or less, depending on recent dyslipidemia treatment
- Willing to provide informed consent and participate in the study
You will not qualify if you...
- Allergy or sensitivity to dapagliflozin, rosuvastatin, or study components
- Pregnant, breastfeeding, or unwilling to use contraception
- Body mass index (BMI) below 15 or above 40 kg/m2
- History of type 1 diabetes, severe diabetes complications, or metabolic acidosis
- Recent acute arterial disease or severe heart conditions
- Uncontrolled high or low blood pressure
- Unstable thyroid function
- History of muscle diseases or elevated creatine kinase
- Severe kidney or liver impairment
- History of drug addiction or major psychiatric disorders
- Recent pancreatitis, infections, or urinary issues
- History of gastrointestinal surgeries or absorption disorders
- Genetic disorders affecting sugar metabolism
- Recent cancer within 5 years with exceptions
- Recent use of insulin, GLP-1 analogues, weight control drugs, or cyclosporin
- Recent use of systemic steroids requiring continued use
- Planned use of iodine contrast or prohibited drugs
- Participation in another clinical trial with investigational products within 3 months
- Other investigator-assessed reasons for ineligibility
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive study drugs including combinations of dapagliflozin and rosuvastatin or placebos over 24 weeks to evaluate efficacy and safety.
Regular visits at 8, 16, and 24 weeks for assessments
Trial Site Locations
Total: 24 locations
1
Hallym university sungsim medical center
Anyang, South Korea, 14068
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2
Buchon sejong hospital
Buchon, South Korea, 14754
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3
Inje university heaundea paik hospital
Busan, South Korea, 48108
Actively Recruiting
4
Soonchunhyang cheonan university hospital
Cheonan, South Korea, 31151
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5
Keimyung University Dongsan Medical Center
Daegu, South Korea, 42601
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6
Daejeon eulji medical center, eulji university
Daejeon, South Korea, 35233
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7
Myongji Hospital
Goyang-si, South Korea, 10475
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8
Hanyang University Medical Center
Guri-si, South Korea, 11923
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9
Chosun University Hospital
Gwangju, South Korea, 61453
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10
Wonkwang university hospital
Iksan, South Korea, 54538
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11
Inha university hospital
Inchon, South Korea, 22332
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12
Chonbuk National University Hospital
Jeonju, South Korea, 54907
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13
Bundang CHA medical center
Seongnam, South Korea, 13496
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14
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
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15
Nowon eulji medical center, eulji university
Seoul, South Korea, 01830
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16
Korea University ANAM Hospital
Seoul, South Korea, 02841
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17
Severance hospital
Seoul, South Korea, 03722
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18
Kyung hee university hospital at gangdong
Seoul, South Korea, 05278
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19
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea, 06591
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20
Hallym university gangnam medical center
Seoul, South Korea, 07441
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21
Korea University Guro Hospital
Seoul, South Korea, 08308
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22
Ajou University Hospital
Suwon, South Korea, 16499
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23
Wonju serverance christian hospital
Wŏnju, South Korea, 26426
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24
Yongin Severance Hospital
Yongin-si, South Korea, 16995
Actively Recruiting
Research Team
C
CMG pharm Co., Ltd
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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