The goal of this observational study is to evaluate the comprehensive clinical efficacy, cardiovascular, renal, and hepatic benefits, as well as the safety of adding Chiglitazar to SGLT-2 inhibitor therapy in adult patients with Type 2 Diabetes Mellitus (T2DM) . The main questions it aims to answer are: What is the real-world effectiveness of Chiglitazar, when added to an SGLT-2 inhibitor, on glycemic control? What are the effects of this combination therapy on cardiovascular, renal, and hepatic outcomes? What is the overall safety of this treatment regimen? This is a non-interventional study. Participants will be prescribed Chiglitazar or other oral antidiabetic drugs by their treating physician as part of their routine clinical care. For the purpose of this registry study, data will be collected from their regular medical follow-ups. Participants will: Attend regular follow-up visits as part of their standard diabetes care. Have data collected from their routine clinical assessments.
Study Type
OBSERVATIONAL
Enrollment
3,550
Prescribed as an add-on therapy to an SGLT-2 inhibitor-based regimen according to the physician's clinical judgment and routine practice
Any oral antidiabetic drug (other than Chiglitazar) prescribed by the treating physician as an add-on therapy to an SGLT-2 inhibitor-based regimen.
Glycated Hemoglobin (HbA1c)
Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months
Time frame: Baseline, 6 Months
N-terminal pro-B-type natriuretic peptide
To assess the change from baseline in N-terminal pro-B-type natriuretic peptide
Time frame: Baseline, 6 Months, 12 Months
High-sensitivity C-reactive Protein
To assess the change from baseline in High-sensitivity C-reactive Protein
Time frame: Baseline, 6 Months, 12 Months
Liver Chemistries: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), and Gamma-Glutamyl Transferase (GGT).
To assess the change from baseline in Liver Function Test Markers: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), and Gamma-Glutamyl Transferase (GGT).
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Renal Function Markers: estimated Glomerular Filtration Rate, Urine Albumin-to-Creatinine Ratio, Serum Creatinine, Blood Urea Nitrogen, Uric Acid, and Cystatin C
To assess the change from baseline in markers for chronic kidney disease, including estimated Glomerular Filtration Rate, Urine Albumin-to-Creatinine Ratio, Serum Creatinine, Blood Urea Nitrogen, Uric Acid, and Cystatin C.
Time frame: Baseline, 6 Months, 12 Months.
Resolution Rate of Metabolic Syndrome
Time frame: 6 Months, 12 Months.
Proportion of Patients Achieving Glycemic Control Targets
To assess the percentage of patients reaching predefined Glycated Hemoglobin targets of \<6.5%, \<7.0%, and \<7.5%.
Time frame: 3 Months, 6 Months, 9 Months, 12 Months.
Glycated Hemoglobin
To assess the change from baseline in Glycated Hemoglobin (HbA1c).
Time frame: Baseline, 3 Months, 9 Months, 12 Months.
Fasting Blood Glucose
To assess the change from baseline in fasting blood glucose.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Patient-Reported Quality of Life (DSQL) score
To measure the change in patient-reported quality of life using the Diabetes-Specific Quality of Life (DSQL) score.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Incidence of Adverse Events
Time frame: Up to 12 months
Medication Costs
To assess the medication costs associated with Type 2 Diabetes.
Time frame: Up to 12 months
Incidence of Major Adverse Cardiovascular Events (MACE)
To assess the number of participants experiencing one or more components of MACE (a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke).
Time frame: Up to 12 months.
non-invasive scores for liver steatosis and fibrosis: Fibrosis-4 Index
Time frame: Baseline, 6 Months,12 Months.
blood pressure (systolic and diastolic)
To assess the change from baseline in blood pressure (systolic and diastolic).
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
body weight
To assess the change from baseline in body weight.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
waist circumference
To assess the change from baseline in waist circumference.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Body Mass Index
To assess the change from baseline in Body Mass Index.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Triglycerides（TG）
To assess the change from baseline in Triglycerides（TG）
Time frame: Baseline, 6 Months, 12 Months
Total Cholesterol (TC)
To assess the change from baseline in Total Cholesterol (TC)
Time frame: Baseline, 6 Months, 12 Months
Low-Density Lipoprotein Cholesterol (LDL-C)
To assess the change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, 6 Months, 12 Months
High-Density Lipoprotein Cholesterol (HDL-C)
To assess the change from baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline, 6 Months, 12 Months
Non-High-Density Lipoprotein Cholesterol (non-HDL-C）
To assess the change from baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C）
Time frame: Baseline, 6 Months, 12 Months
Free Fatty Acids (FFA）
To assess the change from baseline in Free Fatty Acids (FFA）
Time frame: Baseline, 6 Months, 12 Months
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