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NCT Number: NCT07580638

Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes

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.

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Key information

Conditions

T2DM (Type 2 Diabetes Mellitus) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SGLT-2 inhibitor and Chiglitazar

Drug

Prescribed as an add-on therapy to an SGLT-2 inhibitor-based regimen according to the physician's clinical judgment and routine practice

SGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs)

Drug

Any oral antidiabetic drug (other than Chiglitazar) prescribed by the treating physician as an add-on therapy to an SGLT-2 inhibitor-based regimen.

Primary outcomes

  1. Glycated Hemoglobin (HbA1c)

    Time frame: Baseline, 6 Months

    Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months

Secondary outcomes

  1. N-terminal pro-B-type natriuretic peptide

    Time frame: Baseline, 6 Months, 12 Months

    To assess the change from baseline in N-terminal pro-B-type natriuretic peptide

  2. High-sensitivity C-reactive Protein

    Time frame: Baseline, 6 Months, 12 Months

    To assess the change from baseline in High-sensitivity C-reactive Protein

  3. Liver Chemistries: 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.

    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).

  4. Renal Function Markers: 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.

    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.

  5. Resolution Rate of Metabolic Syndrome

    Time frame: 6 Months, 12 Months.

  6. Proportion of Patients Achieving Glycemic Control Targets

    Time frame: 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%.

  7. Glycated Hemoglobin

    Time frame: Baseline, 3 Months, 9 Months, 12 Months.

    To assess the change from baseline in Glycated Hemoglobin (HbA1c).

  8. Fasting Blood Glucose

    Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.

    To assess the change from baseline in fasting blood glucose.

  9. Patient-Reported Quality of Life (DSQL) score

    Time frame: 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.

  10. Incidence of Adverse Events

    Time frame: Up to 12 months

  11. Medication Costs

    Time frame: Up to 12 months

    To assess the medication costs associated with Type 2 Diabetes.

  12. Incidence of Major Adverse Cardiovascular Events (MACE)

    Time frame: 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).

  13. non-invasive scores for liver steatosis and fibrosis: Fibrosis-4 Index

    Time frame: Baseline, 6 Months,12 Months.

  14. blood pressure (systolic and diastolic)

    Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.

    To assess the change from baseline in blood pressure (systolic and diastolic).

  15. body weight

    Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.

    To assess the change from baseline in body weight.

  16. waist circumference

    Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.

    To assess the change from baseline in waist circumference.

  17. Body Mass Index

    Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.

    To assess the change from baseline in Body Mass Index.

  18. Triglycerides（TG）

    Time frame: Baseline, 6 Months, 12 Months

    To assess the change from baseline in Triglycerides（TG）

  19. Total Cholesterol (TC)

    Time frame: Baseline, 6 Months, 12 Months

    To assess the change from baseline in Total Cholesterol (TC)

  20. Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline, 6 Months, 12 Months

    To assess the change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

  21. High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline, 6 Months, 12 Months

    To assess the change from baseline in High-Density Lipoprotein Cholesterol (HDL-C)

  22. Non-High-Density Lipoprotein Cholesterol (non-HDL-C）

    Time frame: Baseline, 6 Months, 12 Months

    To assess the change from baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C）

  23. Free Fatty Acids (FFA）

    Time frame: Baseline, 6 Months, 12 Months

    To assess the change from baseline in Free Fatty Acids (FFA）

Sponsors and collaborators

Lead sponsor

Chipscreen Biosciences, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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