Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
5 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Observationnel
Inscription (Estimé)
3550
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
T2DM patients
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Glycated Hemoglobin (HbA1c)
Délai: Baseline, 6 Months
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months
|
Baseline, 6 Months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
N-terminal pro-B-type natriuretic peptide
Délai: 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
Délai: 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).
Délai: 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
Délai: 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
Délai: 6 Months, 12 Months.
|
6 Months, 12 Months.
|
|
|
Proportion of Patients Achieving Glycemic Control Targets
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Up to 12 months
|
Up to 12 months
|
|
|
Medication Costs
Délai: 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)
Délai: 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
Délai: Baseline, 6 Months,12 Months.
|
Baseline, 6 Months,12 Months.
|
|
|
blood pressure (systolic and diastolic)
Délai: 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
Délai: 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
Délai: 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
Délai: 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）
Délai: Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Triglycerides（TG）
|
Baseline, 6 Months, 12 Months
|
|
Total Cholesterol (TC)
Délai: 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)
Délai: 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)
Délai: 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）
Délai: 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）
Délai: Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Free Fatty Acids (FFA）
|
Baseline, 6 Months, 12 Months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
18 juillet 2026
Achèvement primaire (Estimé)
18 janvier 2028
Achèvement de l'étude (Estimé)
18 juillet 2028
Dates d'inscription aux études
Première soumission
22 avril 2026
Première soumission répondant aux critères de contrôle qualité
5 mai 2026
Première publication (Réel)
12 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Maladies métaboliques
- Troubles du métabolisme du glucose
- Diabète sucré
- Maladies nutritionnelles et métaboliques
- Diabète sucré, Type 2
- Effets physiologiques des drogues
- Mécanismes moléculaires d'action pharmacologique
- Agents hypoglycémiants
- Actions pharmacologiques
- Actions et utilisations chimiques
- Inhibiteurs du transporteur sodium-glucose 2
- chiglitazar
Autres numéros d'identification d'étude
- CGZ401
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .