A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of CMG190303 in Patients With Type 2 Diabetes and Dyslipidemia
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
• 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
⁃ An individual who took a dual combination therapy of an oral diabetes treatment other than metformin and did not take a dyslipidemia treatment: An individual who underwent the wash-out period for at least 6 weeks, the TLC for 2 weeks, and the TLC and placebo run-in period at the same time for 2 weeks
⁃ An individual who took a dual combination therapy of an oral diabetes treatment other than metformin and took a dyslipidemia treatment: An individual who underwent the wash-out period for at least 6 weeks, the TLC for 2 weeks, and the TLC and placebo run-in period at the same time for 2 weeks
• 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