Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
2026年5月5日 更新者：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.
調査の概要
状態
まだ募集していません
条件
研究の種類
観察的
入学 (推定)
3550
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
T2DM patients
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Glycated Hemoglobin (HbA1c)
時間枠：Baseline, 6 Months
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months
|
Baseline, 6 Months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
N-terminal pro-B-type natriuretic peptide
時間枠：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
時間枠：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).
時間枠：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
時間枠：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
時間枠：6 Months, 12 Months.
|
6 Months, 12 Months.
|
|
|
Proportion of Patients Achieving Glycemic Control Targets
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 12 months
|
Up to 12 months
|
|
|
Medication Costs
時間枠：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)
時間枠：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
時間枠：Baseline, 6 Months,12 Months.
|
Baseline, 6 Months,12 Months.
|
|
|
blood pressure (systolic and diastolic)
時間枠：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
時間枠：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
時間枠：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
時間枠：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）
時間枠：Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Triglycerides（TG）
|
Baseline, 6 Months, 12 Months
|
|
Total Cholesterol (TC)
時間枠：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)
時間枠：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)
時間枠：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）
時間枠：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）
時間枠：Baseline, 6 Months, 12 Months
|
To assess the change from baseline in Free Fatty Acids (FFA）
|
Baseline, 6 Months, 12 Months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月18日
一次修了 (推定)
2028年1月18日
研究の完了 (推定)
2028年7月18日
試験登録日
最初に提出
2026年4月22日
QC基準を満たした最初の提出物
2026年5月5日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年5月5日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。