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Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes

5 mei 2026 bijgewerkt door: Chipscreen Biosciences, Ltd.

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

3550

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

T2DM patients

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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).
Geneesmiddel: 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)
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Glycated Hemoglobin (HbA1c)
Tijdsspanne: Baseline, 6 Months
Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months
Baseline, 6 Months

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chipscreen Biosciences, Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

18 juli 2026

Primaire voltooiing (Geschat)

18 januari 2028

Studie voltooiing (Geschat)

18 juli 2028

Studieregistratiedata

Eerst ingediend

22 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

5 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CGZ401

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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