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

Sponsor
CMG Pharmaceutical Co. Ltd
Study ID
NCT06772168
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Apr 19, 2024
Status verified
Jul 2025
Primary completion
Nov 4, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CMG190303(Dapagliflozin/Rosuvastatin)
  • Placebo Comparator: Comparator 1: Dapagliflozin/Rosuvastatin placebo
  • Placebo Comparator: Comparator 2: Rosuvastatin/Dapagliflozin placebo

Primary Outcome Measure

To compare the change in HbA1c (%) [ Time Frame: From enrollment to the end of treatment at 24 weeks ]

Central Contacts

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