T2DM (Type 2 Diabetes Mellitus)NCT07580638
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
An observational study of T2DM (Type 2 Diabetes Mellitus), run by Chipscreen Biosciences, Ltd. at 2 sites in China.
Trial summary
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) . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- SGLT-2 inhibitor and Chiglitazar and SGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs)
- Type of treatment
- Pill or oral medicine
- How many people
- 3,550 participants
- Where
- 2 sitesChina
- Study dates
- 4 Sep 2026to 18 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: T2DM patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Guo, +86 13901317569, glx1218@163.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Tong, +86 18980601196, tongnw@scu.edu.cn
About this study
Official title: 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?
Read more
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.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- SGLT-2 inhibitor and Chiglitazar, SGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT-2 inhibitor and ChiglitazarDrug
Prescribed as an add-on therapy to an SGLT-2 inhibitor-based regimen according to the physician's clinical judgment and routine practice
SGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs)Drug
Any oral antidiabetic drug (other than Chiglitazar) prescribed by the treating physician as an add-on therapy to an SGLT-2 inhibitor-based regimen.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: SGLT-2 inhibitor and Chiglitazar | |
| Comparator Cohort (Control Group) | Participants with T2DM on a background SGLT-2 inhibitor-based therapy who are prescribed oral antidiabetic drugs (other than Chiglitazar) Receives: Drug: SGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin (HbA1c)
Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months
Measured: Baseline, 6 Months
Secondary outcomes (23)
N-terminal pro-B-type natriuretic peptide
To assess the change from baseline in N-terminal pro-B-type natriuretic peptide
Measured: Baseline, 6 Months, 12 Months
High-sensitivity C-reactive Protein
To assess the change from baseline in High-sensitivity C-reactive Protein
Measured: Baseline, 6 Months, 12 Months
Liver Chemistries: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), and Gamma-Glutamyl Transferase (GGT).
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).
Measured: 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
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.
Measured: Baseline, 6 Months, 12 Months.
Resolution Rate of Metabolic Syndrome
Measured: 6 Months, 12 Months.
Proportion of Patients Achieving Glycemic Control Targets
To assess the percentage of patients reaching predefined Glycated Hemoglobin targets of <6.5%, <7.0%, and <7.5%.
Measured: 3 Months, 6 Months, 9 Months, 12 Months.
Glycated Hemoglobin
To assess the change from baseline in Glycated Hemoglobin (HbA1c).
Measured: Baseline, 3 Months, 9 Months, 12 Months.
Fasting Blood Glucose
To assess the change from baseline in fasting blood glucose.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Patient-Reported Quality of Life (DSQL) score
To measure the change in patient-reported quality of life using the Diabetes-Specific Quality of Life (DSQL) score.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Incidence of Adverse Events
Measured: Up to 12 months
Medication Costs
To assess the medication costs associated with Type 2 Diabetes.
Measured: Up to 12 months
Incidence of Major Adverse Cardiovascular Events (MACE)
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).
Measured: Up to 12 months.
non-invasive scores for liver steatosis and fibrosis: Fibrosis-4 Index
Measured: Baseline, 6 Months,12 Months.
blood pressure (systolic and diastolic)
To assess the change from baseline in blood pressure (systolic and diastolic).
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
body weight
To assess the change from baseline in body weight.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
waist circumference
To assess the change from baseline in waist circumference.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Body Mass Index
To assess the change from baseline in Body Mass Index.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Triglycerides（TG）
To assess the change from baseline in Triglycerides（TG）
Measured: Baseline, 6 Months, 12 Months
Total Cholesterol (TC)
To assess the change from baseline in Total Cholesterol (TC)
Measured: Baseline, 6 Months, 12 Months
Low-Density Lipoprotein Cholesterol (LDL-C)
To assess the change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Measured: Baseline, 6 Months, 12 Months
High-Density Lipoprotein Cholesterol (HDL-C)
To assess the change from baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Measured: Baseline, 6 Months, 12 Months
Non-High-Density Lipoprotein Cholesterol (non-HDL-C）
To assess the change from baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C）
Measured: Baseline, 6 Months, 12 Months
Free Fatty Acids (FFA）
To assess the change from baseline in Free Fatty Acids (FFA）
Measured: Baseline, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start4 Sep 2026
- Primary completion18 Jan 2028 (estimated)
- Study completion18 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by Chipscreen Biosciences, Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580638
- Sponsor's protocol ID
- CGZ401
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiglitazar Add-On to SGLT-2 Inhibitors in Patients With Type 2 Diabetes: A Nationwide, Multicenter Registry Study (C-STAR)
- ClinicalTrials.gov ID
- NCT07580638
- Acronym / sponsor ID
- CGZ401
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,550 participants (estimated)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2026 (actual)
- Primary completion
- 18 Jan 2028 (estimated)
- Study completion
- 18 Jul 2028 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiglitazar Cohort (Exposure Group) | – | Drug: SGLT-2 inhibitor and ChiglitazarParticipants 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). |
| Comparator Cohort (Control Group) | – | Drug: SGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs)Participants with T2DM on a background SGLT-2 inhibitor-based therapy who are prescribed oral antidiabetic drugs (other than Chiglitazar) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- T2DM patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT-2 inhibitor and ChiglitazarPrescribed as an add-on therapy to an SGLT-2 inhibitor-based regimen according to the physician's clinical judgment and routine practice | Drug | Chiglitazar Cohort (Exposure Group) |
| 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. | Drug | Comparator Cohort (Control Group) |
Primary outcome
Glycated Hemoglobin (HbA1c)
Time frame: Baseline, 6 Months
Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months
23 secondary outcomes
N-terminal pro-B-type natriuretic peptide
Time frame: Baseline, 6 Months, 12 Months
High-sensitivity C-reactive Protein
Time frame: Baseline, 6 Months, 12 Months
Liver Chemistries: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), and Gamma-Glutamyl Transferase (GGT).
Time frame: 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
Time frame: Baseline, 6 Months, 12 Months.
Resolution Rate of Metabolic Syndrome
Time frame: 6 Months, 12 Months.
Proportion of Patients Achieving Glycemic Control Targets
Time frame: 3 Months, 6 Months, 9 Months, 12 Months.
Glycated Hemoglobin
Time frame: Baseline, 3 Months, 9 Months, 12 Months.
Fasting Blood Glucose
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Patient-Reported Quality of Life (DSQL) score
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Incidence of Adverse Events
Time frame: Up to 12 months
Medication Costs
Time frame: Up to 12 months
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: Up to 12 months.
non-invasive scores for liver steatosis and fibrosis: Fibrosis-4 Index
Time frame: Baseline, 6 Months,12 Months.
blood pressure (systolic and diastolic)
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
body weight
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
waist circumference
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Body Mass Index
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Triglycerides（TG）
Time frame: Baseline, 6 Months, 12 Months
Total Cholesterol (TC)
Time frame: Baseline, 6 Months, 12 Months
Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, 6 Months, 12 Months
High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline, 6 Months, 12 Months
Non-High-Density Lipoprotein Cholesterol (non-HDL-C）
Time frame: Baseline, 6 Months, 12 Months
Free Fatty Acids (FFA）
Time frame: Baseline, 6 Months, 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T2DM (Type 2 Diabetes Mellitus), run by Chipscreen Biosciences, Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang (+86 0755-36993550, xinhwang@chipscreen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin (HbA1c) (time frame: Baseline, 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.