Phase 3 Study to Evaluate the Safety and Effectiveness of CMG190303 Compared to Rosuvastatin and Dapagliflozin in Adults with Type 2 Diabetes and Dyslipidemia

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 drugs effects and safety in adults with these conditions.

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