Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes

Chiglitazar Add-On to SGLT-2 Inhibitors in Patients With Type 2 Diabetes: A Nationwide, Multicenter Registry Study (C-STAR)

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 Overview

• Status: Not yet recruiting
• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Intervention / Treatment: Drug: SGLT-2 inhibitor and Chiglitazar; Drug: SGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs)

• Study Type: Observational
• Enrollment (Estimated): 3550

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

T2DM patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chiglitazar Cohort (Exposure Group); Participants with T2DM on a background SGLT-2 inhibitor-based therapy who are newly prescribed Chiglitazar by their treating physician. This cohort includes patients on dual therapy (SGLT-2i + Chiglitazar) or triple therapy (SGLT-2i + Chiglitazar + another oral antidiabetic drug).	Drug: SGLT-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
Comparator Cohort (Control Group); Participants with T2DM on a background SGLT-2 inhibitor-based therapy who are prescribed oral antidiabetic drugs (other than Chiglitazar)	Drug: SGLT-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated Hemoglobin (HbA1c)	Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months	Baseline, 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
N-terminal pro-B-type natriuretic peptide	To assess the change from baseline in N-terminal pro-B-type natriuretic peptide	Baseline, 6 Months, 12 Months
High-sensitivity C-reactive Protein	To assess the change from baseline in High-sensitivity C-reactive Protein	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).	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.	Baseline, 6 Months, 12 Months.
Resolution Rate of Metabolic Syndrome		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%.	3 Months, 6 Months, 9 Months, 12 Months.
Glycated Hemoglobin	To assess the change from baseline in Glycated Hemoglobin (HbA1c).	Baseline, 3 Months, 9 Months, 12 Months.
Fasting Blood Glucose	To assess the change from baseline in fasting blood glucose.	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.	Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Incidence of Adverse Events		Up to 12 months
Medication Costs	To assess the medication costs associated with Type 2 Diabetes.	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).	Up to 12 months.
non-invasive scores for liver steatosis and fibrosis: Fibrosis-4 Index		Baseline, 6 Months,12 Months.
blood pressure (systolic and diastolic)	To assess the change from baseline in blood pressure (systolic and diastolic).	Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
body weight	To assess the change from baseline in body weight.	Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
waist circumference	To assess the change from baseline in waist circumference.	Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Body Mass Index	To assess the change from baseline in Body Mass Index.	Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Triglycerides（TG）	To assess the change from baseline in Triglycerides（TG）	Baseline, 6 Months, 12 Months
Total Cholesterol (TC)	To assess the change from baseline in Total Cholesterol (TC)	Baseline, 6 Months, 12 Months
Low-Density Lipoprotein Cholesterol (LDL-C)	To assess the change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C)	Baseline, 6 Months, 12 Months
High-Density Lipoprotein Cholesterol (HDL-C)	To assess the change from baseline in High-Density Lipoprotein Cholesterol (HDL-C)	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）	Baseline, 6 Months, 12 Months
Free Fatty Acids (FFA）	To assess the change from baseline in Free Fatty Acids (FFA）	Baseline, 6 Months, 12 Months

Collaborators and Investigators

• Sponsor: Chipscreen Biosciences, Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 18, 2026
• Primary Completion (Estimated): January 18, 2028
• Study Completion (Estimated): July 18, 2028

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Pharmacologic Actions; Chemical Actions and Uses; Sodium-Glucose Transporter 2 Inhibitors; chiglitazar
• Other Study ID Numbers: CGZ401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No