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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMG190303(Dapagliflozin/Rosuvastatin) | Experimental |
| |
| Comparator 1: Dapagliflozin/Rosuvastatin placebo | Placebo Comparator |
| |
| Comparator 2: Rosuvastatin/Dapagliflozin placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with HbA1c < 6.5% | at 8, 16, and 24 weeks from baseline after administration of the investigational medicinal product | From enrollment to 8, 16, and 24 weeks |
| The change in blood pressure (SBP/DBP) (mmHg) |
Screening (Visit 1) Inclusion Criteria
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
An individual meeting the following criteria for HbA1c at the time of the screening
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
Randomization (Visit 2) Inclusion Criteria
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 with 7.0% ≤ HbA1c ≤ 10.5% based on the central laboratory test on a visit 1-4 (Run-in visit)
An individual with FPG (Fasting Plasma Glucose) ≤ 270 mg/dL based on the central laboratory test on a visit 1-4 (Run-in visit)
An individual whose fasting serum lipid test level is 100 mg/dL ≤ LDL-C ≤ 250 mg/dL and TG ≤ 400 mg/dL based on the central laboratory test on a visit 1-4 (Run-in visit)
An individual with medication compliance of 70% or higher during the run-in period
Screening Visit (Visit 1) Exclusion Criteria
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
An individual with a history of administering any of the following drugs within 3 months prior to the screening
An individual who has a history of administering a systemic steroid agent within 2 weeks from the screening and requires administration of a systemic steroid agent during the clinical study
An individual who is scheduled to have an examination using an iodine contrast agent, or is contraindicated to use of metformin due to acute and chronic metabolic acidosis, etc.
An individual who is expected to use a 7.6.1 prohibited concomitant drug during the clinical study, including the screening (use of any prescription drugs and over-the-counter drugs, including prohibited concomitant drugs, must be discussed with the investigator prior to use)
A patient who participated in another clinical study and used/applied another investigational product and medical device within 3 months (exceptionally, a patient who participated in a non-interventional observation study may participate in the present study)
A patient otherwise considered ineligible for participation in the clinical study in the opinion of the investigator
Randomization Visit (Visit 2) Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CMG pharm Co., Ltd | Contact | 82+31-881-7699 | hwjho@chamc.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym university sungsim medical center | Recruiting | Anyang | 14068 | South Korea | ||
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| Comparator 1: Dapagliflozin/Rosuvastatin placebo | Drug | 0-24 week: Dapagliflozin 10mg and Rosuvastatin placebo |
|
| 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 |
|
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: 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 | From enrollment to 8, 16, and 24 weeks |
| The change in HbA1c (%) | from baseline to 24 weeks in the rosuvastatin monotherapy group | 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
| From enrollment to 8, 16, and 24 weeks |
| The change in body weight (kg) | from baseline to 8, 16, and 24 weeks after administration of the investigational medicinal product | From enrollment to 8, 16, and 24 weeks |
| The proportion of subjects who used rescue medication and the associated change in HbA1c (%) from baseline to 24 weeks | From enrollment to 8, 16, and 24 weeks |
| Buchon sejong hospital |
| Recruiting |
| Buchon |
| 14754 |
| South Korea |
| Inje university heaundea paik hospital | Recruiting | Busan | 48108 | South Korea |
| Soonchunhyang cheonan university hospital | Recruiting | Cheonan | 31151 | South Korea |
| Keimyung University Dongsan Medical Center | Recruiting | Daegu | 42601 | South Korea |
| Daejeon eulji medical center, eulji university | Recruiting | Daejeon | 35233 | South Korea |
| Myongji Hospital | Recruiting | Goyang-si | 10475 | South Korea |
| Hanyang University Medical Center | Recruiting | Guri-si | 11923 | South Korea |
| Chosun University Hospital | Recruiting | Gwangju | 61453 | South Korea |
| Wonkwang university hospital | Recruiting | Iksan | 54538 | South Korea |
| Inha university hospital | Recruiting | Inchon | 22332 | South Korea |
| Chonbuk National University Hospital | Recruiting | Jeonju | 54907 | South Korea |
| Bundang CHA medical center | Recruiting | Seongnam | 13496 | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Seongnam | 13620 | South Korea |
| Nowon eulji medical center, eulji university | Recruiting | Seoul | 01830 | South Korea |
| Korea University ANAM Hospital | Recruiting | Seoul | 02841 | South Korea |
| Severance hospital | Recruiting | Seoul | 03722 | South Korea |
| Kyung hee university hospital at gangdong | Recruiting | Seoul | 05278 | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
| Hallym university gangnam medical center | Recruiting | Seoul | 07441 | South Korea |
| Korea University Guro Hospital | Recruiting | Seoul | 08308 | South Korea |
| Ajou University Hospital | Recruiting | Suwon | 16499 | South Korea |
| Wonju serverance christian hospital | Recruiting | Wŏnju | 26426 | South Korea |
| Yongin Severance Hospital | Recruiting | Yongin-si | 16995 | South Korea |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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