Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
5 maj 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Observationell
Inskrivning (Beräknad)
3550
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
T2DM patients
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Glycated Hemoglobin (HbA1c)
Tidsram: Baseline, 6 Months
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months
|
Baseline, 6 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
N-terminal pro-B-type natriuretic peptide
Tidsram: 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
Tidsram: 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).
Tidsram: 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
Tidsram: 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
Tidsram: 6 Months, 12 Months.
|
6 Months, 12 Months.
|
|
|
Proportion of Patients Achieving Glycemic Control Targets
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 12 months
|
Up to 12 months
|
|
|
Medication Costs
Tidsram: 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)
Tidsram: 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
Tidsram: Baseline, 6 Months,12 Months.
|
Baseline, 6 Months,12 Months.
|
|
|
blood pressure (systolic and diastolic)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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）
Tidsram: Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Triglycerides（TG）
|
Baseline, 6 Months, 12 Months
|
|
Total Cholesterol (TC)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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）
Tidsram: 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）
Tidsram: Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Free Fatty Acids (FFA）
|
Baseline, 6 Months, 12 Months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
18 juli 2026
Primärt slutförande (Beräknad)
18 januari 2028
Avslutad studie (Beräknad)
18 juli 2028
Studieregistreringsdatum
Först inskickad
22 april 2026
Först inskickad som uppfyllde QC-kriterierna
5 maj 2026
Första postat (Faktisk)
12 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 maj 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Diabetes mellitus
- Närings- och metabola sjukdomar
- Diabetes mellitus, typ 2
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Hypoglykemiska medel
- Farmakologiska åtgärder
- Kemiska åtgärder och användningar
- Sodium-Glucose Transporter 2-hämmare
- chiglitazar
Andra studie-ID-nummer
- CGZ401
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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