Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
5. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Observasjonsmessig
Registrering (Antatt)
3550
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
T2DM patients
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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).
|
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)
|
Any oral antidiabetic drug (other than Chiglitazar) prescribed by the treating physician as an add-on therapy to an SGLT-2 inhibitor-based regimen.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Glycated Hemoglobin (HbA1c)
Tidsramme: Baseline, 6 Months
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months
|
Baseline, 6 Months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
N-terminal pro-B-type natriuretic peptide
Tidsramme: 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
Tidsramme: 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).
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 Months, 12 Months.
|
6 Months, 12 Months.
|
|
|
Proportion of Patients Achieving Glycemic Control Targets
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
|
Medication Costs
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline, 6 Months,12 Months.
|
Baseline, 6 Months,12 Months.
|
|
|
blood pressure (systolic and diastolic)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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）
Tidsramme: Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Triglycerides（TG）
|
Baseline, 6 Months, 12 Months
|
|
Total Cholesterol (TC)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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）
Tidsramme: 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）
Tidsramme: Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Free Fatty Acids (FFA）
|
Baseline, 6 Months, 12 Months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
18. juli 2026
Primær fullføring (Antatt)
18. januar 2028
Studiet fullført (Antatt)
18. juli 2028
Datoer for studieregistrering
Først innsendt
22. april 2026
Først innsendt som oppfylte QC-kriteriene
5. mai 2026
Først lagt ut (Faktiske)
12. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. mai 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Metabolske sykdommer
- Glukosemetabolismeforstyrrelser
- Sukkersyke
- Ernæringsmessige og metabolske sykdommer
- Diabetes mellitus, type 2
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Hypoglykemiske midler
- Farmakologiske handlinger
- Kjemiske handlinger og bruk
- Sodium-Glucose Transporter 2-hemmere
- chiglitazar
Andre studie-ID-numre
- CGZ401
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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