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Recruiting Phase 3 NCT06772168

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

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Trial Parameters

Condition Dyslipidemia
Sponsor CMG Pharmaceutical Co. Ltd
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 240
Sex ALL
Min Age 19 Years
Max Age 80 Years
Start Date 2024-04-19
Completion 2026-11-04
Interventions
CMG190303(Dapagliflozin/Rosuvastatin)Comparator 1: Dapagliflozin/Rosuvastatin placeboRosuvastatin/Dapagliflozin placebo

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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: -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

Eligibility Criteria

Screening (Visit 1) Inclusion Criteria 1. A male or female adult aged between 19 and 80 in South Korea 2. An individual with type II diabetes and dyslipidemia 3. An individual meeting any of the followings at the time of the screening 1. 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) 2. 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) 4. An individual meeting the following criteria for HbA1c at the time of the screening 1. Metformin monotherapy: An individual with 7.0% ≤ HbA1c ≤ 10.5% whose blood sugar level is not adequately co

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