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

NCT06772168 | Recruiting Phase 3

• 1 other identifier: CMG1903-104
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 24

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:

1. 1.To compare the change in HbA1c from baseline to 24 weeks between CMG190303 and Rosuvastatin
2. 2.To compare the change in LDL-C from baseline to 24 weeks between CMG190303 and Dapagliflozin

Conditions

Dyslipidemia; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• To compare the change in HbA1c (%)

  From enrollment to the end of treatment at 24 weeks

• The percentage change in LDL-C

  From enrollment to the end of treatment at 24 weeks

• The proportion of subjects achieving LDL-C target levels by cardiovascular risk category

  From enrollment to 8, 16, and 24 weeks

• The change in fasting plasma glucose (FPG) (mg/dL)

  From enrollment to 8, 16, and 24 weeks

• The percentage change in the following lipid parameters

  From enrollment to 8, 16, and 24 weeks

Other Outcomes (4)

• The proportion of subjects with HbA1c < 6.5%

  From enrollment to 8, 16, and 24 weeks

• The change in blood pressure (SBP/DBP) (mmHg)

  From enrollment to 8, 16, and 24 weeks

• The change in body weight (kg)

  From enrollment to 8, 16, and 24 weeks

Study Arms (3)

CMG190303(Dapagliflozin/Rosuvastatin)

EXPERIMENTAL

Drug: CMG190303(Dapagliflozin/Rosuvastatin)

Comparator 1: Dapagliflozin/Rosuvastatin placebo

PLACEBO COMPARATOR

Drug: Comparator 1: Dapagliflozin/Rosuvastatin placebo

Comparator 2: Rosuvastatin/Dapagliflozin placebo

PLACEBO COMPARATOR

Drug: Rosuvastatin/Dapagliflozin placebo

Interventions

Rosuvastatin/Dapagliflozin placebo DRUG

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

Comparator 2: Rosuvastatin/Dapagliflozin placebo

CMG190303(Dapagliflozin/Rosuvastatin) DRUG

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

CMG190303(Dapagliflozin/Rosuvastatin)

Comparator 1: Dapagliflozin/Rosuvastatin placebo DRUG

0-24 week: Dapagliflozin 10mg and Rosuvastatin placebo

Comparator 1: Dapagliflozin/Rosuvastatin placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A male or female adult aged between 19 and 80 in South Korea
• An individual with type II diabetes and dyslipidemia
• An individual meeting any of the followings at the time of the screening
• Metformin monotherapy: An individual who was on a stable dose of metformin ≥1,000 mg/day as monotherapy for at least 6 weeks prior to screening (for a patient who took a dyslipidemia treatment within 4 weeks from the screening, the patient had to be on a stable dose of metformin ≥1,000 mg/day as monotherapy for at least 2 weeks prior to the screening)
• Dual combination therapy: An individual who was on a stable dose of metformin ≥1,000 mg/day for at least 1 week prior to the screening in combination with additional oral diabetes treatment (DPP-4i, TZD, SU)
• An individual meeting the following criteria for HbA1c at the time of the screening
• Metformin monotherapy: An individual with 7.0% ≤ HbA1c ≤ 10.5% whose blood sugar level is not adequately controlled
• Dual combination therapy: An individual with 6.5% ≤ HbA1c ≤ 10% whose blood sugar level is not adequately controlled
• An individual with FPG (Fasting Plasma Glucose) ≤ 270 mg/dL at the time of the screening
• A patient who did not take a dyslipidemia treatment within 4 weeks from the screening and whose fasting serum lipid test level is 100 mg/dL ≤ LDL-C ≤ 250 mg/dL and TG ≤ 400 mg/dL
• A patient who took a dyslipidemia treatment within 4 weeks from the screening and was on monotherapy of a statin-class drug as a dyslipidemia treatment for at least 6 weeks prior to the screening (an individual who took omega-3 alone or omega-3 in combination with a statin-class drug is considered to have taken the monotherapy of a statin drug as described here)
• An individual who voluntarily consented to participating in the clinical study and signed the informed consent form
• An individual who continuously took metformin ≥1,000 mg/day before the randomization (after the screening visit (Visit 1)) and underwent the wash-out period, TLC and run-in period as described below
• An individual who took metformin monotherapy but did not take a dyslipidemia treatment: An individual who underwent the TLC for 2 weeks and the TLC and placebo run-in period at the same time for 2 weeks
• An individual who took metformin monotherapy and took a dyslipidemia treatment: An individual who underwent the wash-out period for at least 4 weeks, the TLC for 2 weeks, and the TLC and placebo run-in period at the same time for 2 weeks

You may not qualify if:

• A patient with hypersensitivity to the active ingredient (dapagliflozin or rosuvastatin) or any component of the investigational product
• A pregnant woman, a breastfeeding woman, or a woman of childbearing potential or a man who does not agree to use an appropriate contraceptive method\* during the clinical study
• \*: a. Implantation of an intrauterine device or intrauterine system, b. Dual barrier method for men or women of childbearing potential (condom and contraceptive vaginal diaphragm, vaginal sponge or cervical cap), c. Sterilization (vasectomy, bilateral tubal ligation, etc.)
• A patient with the body mass index (BMI) \< 15 kg/m2 or \> 40 kg/m2
• An individual with the following medical history or laboratory test abnormality
• A patient with type I diabetes or secondary diabetes or severe diabetes complications
• A patient with metabolic acidosis such as diabetic ketoacidosis
• A patient with acute arterial disease at the time of screening (e.g., a patient with a medical history of unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or coronary intervention within 3 months prior to entry to the study)
• A patient with a medical history of severe heart failure (NYHA class III to IV), severe heart valve disease, severe obstructive/hypertrophic myocardial disease, severe obstructive coronary artery disease, abdominal aneurysm, or uncontrolled arrhythmia, that occurred within 24 weeks prior to the screening
• A patient with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg) or hypotension (systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg)
• An individual with uncontrolled thyroid dysfunction (TSH (Thyroid Stimulating Hormone) ≥ 1.5 X ULN, or an inability to maintain a stable TSH level in the opinion of the investigator)
• An individual with a medical history of myopathy, including rhabdomyolysis, or whose CK is 2 times or higher the upper limit of normal range of CK
• A patient with severe renal impairment (eGFR \< 45 mL/min/1.73 m2 for a patient taking metformin at 1,000 mg, or eGFR \< 60 mL/min/1.73 m2 for a patient taking metformin at \> 1,000 mg) or hepatic impairment (AST or ALT is 2.5 times the upper limit of normal range)
• An individual with a past history of drug addiction or alcoholism within 1 year from the screening
• An individual with major psychiatric disease: Schizophrenia, mood disorder (depression, bipolar disorder), anxiety disorder, obsessive disorder, eating disorder, personality disorder, etc.

Sponsors & Collaborators

• CMG Pharmaceutical Co. Ltd: lead

Study Sites (24)

Hallym university sungsim medical center

Anyang, 14068, South Korea

RECRUITING

Buchon sejong hospital

Buchon, 14754, South Korea

RECRUITING

Inje university heaundea paik hospital

Busan, 48108, South Korea

RECRUITING

Soonchunhyang cheonan university hospital

Cheonan, 31151, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

RECRUITING

Daejeon eulji medical center, eulji university

Daejeon, 35233, South Korea

RECRUITING

Myongji Hospital

Goyang-si, 10475, South Korea

RECRUITING

Hanyang University Medical Center

Guri-si, 11923, South Korea

RECRUITING

Chosun University Hospital

Gwangju, 61453, South Korea

RECRUITING

Wonkwang university hospital

Iksan, 54538, South Korea

RECRUITING

Inha university hospital

Inchon, 22332, South Korea

RECRUITING

Chonbuk National University Hospital

Jeonju, 54907, South Korea

RECRUITING

Bundang CHA medical center

Seongnam, 13496, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

RECRUITING

Nowon eulji medical center, eulji university

Seoul, 01830, South Korea

RECRUITING

Korea University ANAM Hospital

Seoul, 02841, South Korea

RECRUITING

Severance hospital

Seoul, 03722, South Korea

RECRUITING

Kyung hee university hospital at gangdong

Seoul, 05278, South Korea

RECRUITING

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

Seoul, 06591, South Korea

RECRUITING

Hallym university gangnam medical center

Seoul, 07441, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Ajou University Hospital

Suwon, 16499, South Korea

RECRUITING

Wonju serverance christian hospital

Wŏnju, 26426, South Korea

RECRUITING

Yongin Severance Hospital

Yongin-si, 16995, South Korea

RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Diabetes Mellitus, Type 2

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

CMG pharm Co., Ltd

CONTACT

82+31-881-7699; hwjho@chamc.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: April 19, 2024
• Primary Completion (Estimated): November 4, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2025-07

Locations

KR (24)