T2DM (Type 2 Diabetes Mellitus)
Conditions
Brief summary
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.
Interventions
DRUGSGLT-2 inhibitor and Chiglitazar
Prescribed as an add-on therapy to an SGLT-2 inhibitor-based regimen according to the physician's clinical judgment and routine practice
DRUGSGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs)
Any oral antidiabetic drug (other than Chiglitazar) prescribed by the treating physician as an add-on therapy to an SGLT-2 inhibitor-based regimen.
Sponsors
Chipscreen Biosciences, Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years, inclusive. * Diagnosis of Type 2 Diabetes Mellitus (T2DM) . * Receiving stable-dose SGLT-2 inhibitor monotherapy or in combination with one other oral antidiabetic drug for at least one month prior to screening, but with inadequate glycemic control, defined as HbA1c ≥ 7.5%. * Must be willing to participate and have provided written informed consent.
Exclusion criteria
* Current or routine use of insulin therapy. * Use of three or more antidiabetic drugs within one month prior to screening. * Current treatment with a thiazolidinedione (TZD) or a GLP-1 receptor agonist (GLP-1 RA). * Prior treatment with Chiglitazar Sodium. * Presence of life-threatening comorbidities, severe edema, or severe hepatic impairment (Child-Pugh Class C). * Laboratory findings meeting any of the following criteria: a) Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 5 times the upper limit of normal (ULN); b) Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m².
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin (HbA1c) | Baseline, 6 Months | Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| N-terminal pro-B-type natriuretic peptide | Baseline, 6 Months, 12 Months | To assess the change from baseline in N-terminal pro-B-type natriuretic peptide |
| High-sensitivity C-reactive Protein | Baseline, 6 Months, 12 Months | To assess the change from baseline in High-sensitivity C-reactive Protein |
| Liver Chemistries: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), and Gamma-Glutamyl Transferase (GGT). | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | 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). |
| Renal Function Markers: estimated Glomerular Filtration Rate, Urine Albumin-to-Creatinine Ratio, Serum Creatinine, Blood Urea Nitrogen, Uric Acid, and Cystatin C | Baseline, 6 Months, 12 Months. | 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. |
| Resolution Rate of Metabolic Syndrome | 6 Months, 12 Months. | — |
| Proportion of Patients Achieving Glycemic Control Targets | 3 Months, 6 Months, 9 Months, 12 Months. | To assess the percentage of patients reaching predefined Glycated Hemoglobin targets of \<6.5%, \<7.0%, and \<7.5%. |
| Glycated Hemoglobin | Baseline, 3 Months, 9 Months, 12 Months. | To assess the change from baseline in Glycated Hemoglobin (HbA1c). |
| Fasting Blood Glucose | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | To assess the change from baseline in fasting blood glucose. |
| Patient-Reported Quality of Life (DSQL) score | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | To measure the change in patient-reported quality of life using the Diabetes-Specific Quality of Life (DSQL) score. |
| Incidence of Adverse Events | Up to 12 months | — |
| Medication Costs | Up to 12 months | To assess the medication costs associated with Type 2 Diabetes. |
| Incidence of Major Adverse Cardiovascular Events (MACE) | Up to 12 months. | 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). |
| non-invasive scores for liver steatosis and fibrosis: Fibrosis-4 Index | Baseline, 6 Months,12 Months. | — |
| blood pressure (systolic and diastolic) | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | To assess the change from baseline in blood pressure (systolic and diastolic). |
| body weight | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | To assess the change from baseline in body weight. |
| waist circumference | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | To assess the change from baseline in waist circumference. |
| Body Mass Index | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | To assess the change from baseline in Body Mass Index. |
| Triglycerides（TG） | Baseline, 6 Months, 12 Months | To assess the change from baseline in Triglycerides（TG） |
| Total Cholesterol (TC) | Baseline, 6 Months, 12 Months | To assess the change from baseline in Total Cholesterol (TC) |
| Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline, 6 Months, 12 Months | To assess the change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) |
| High-Density Lipoprotein Cholesterol (HDL-C) | Baseline, 6 Months, 12 Months | To assess the change from baseline in High-Density Lipoprotein Cholesterol (HDL-C) |
| Non-High-Density Lipoprotein Cholesterol (non-HDL-C） | Baseline, 6 Months, 12 Months | To assess the change from baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C） |
| Free Fatty Acids (FFA） | Baseline, 6 Months, 12 Months | To assess the change from baseline in Free Fatty Acids (FFA） |
Outcome results
None listed