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Not yet recruiting NCT07580638

Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes

— Observational T2DM (Type 2 Diabetes Mellitus)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SGLT-2 inhibitor and Chiglitazar, SGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs).
Who it may be relevant to
Registry conditions: T2DM (Type 2 Diabetes Mellitus). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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
  • 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.

Primary outcome measures

  • Glycated Hemoglobin (HbA1c) [Time frame: Baseline, 6 Months]
Secondary outcome measures (12)
  • N-terminal pro-B-type natriuretic peptide [Time frame: Baseline, 6 Months, 12 Months]
  • 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). [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 [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 [Time frame: 3 Months, 6 Months, 9 Months, 12 Months.]
  • Glycated Hemoglobin [Time frame: Baseline, 3 Months, 9 Months, 12 Months.]
  • Fasting Blood Glucose [Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.]
  • Patient-Reported 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 [Time frame: Up to 12 months]
  • Incidence of Major Adverse Cardiovascular Events (MACE) [Time frame: Up to 12 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07580638 · CGZ401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗