Chiglitazar added to SGLT-2 inhibitors for type 2 diabetes
Official title: Chiglitazar Add-On to SGLT-2 Inhibitors in Patients With Type 2 Diabetes: A Nationwide, Multicenter Registry Study (C-STAR)
Run by Chipscreen Biosciences, Ltd. · NCT07580638 · Data updated 2026-11-12
This real-world registry tests whether adding chiglitazar to ongoing SGLT-2 inhibitor therapy helps adults with type 2 diabetes improve blood sugar control and supports heart, kidney, and liver safety.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 3550 (estimated) |
| Sponsor | Chipscreen Biosciences, Ltd. Industry-sponsored |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | September 4, 2026 |
| Main results expected | January 18, 2028 |
| Study ends | July 18, 2028 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07580638 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with type 2 diabetes, currently on stable SGLT-2 inhibitor therapy (with or without one other OAD) and HbA1c ≥ 7.5%.
✕Probably not a fit
Patients who are on insulin therapy, on three or more antidiabetic drugs, or with severe liver disease, kidney failure, or other serious contraindications may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, non-interventional registry enrolling adults with type 2 diabetes who are already on an SGLT-2 inhibitor and may add chiglitazar or other oral antidiabetic drugs as part of routine care. Data are collected from regular follow-up visits to assess glycemic control, cardiovascular, renal, and hepatic outcomes, plus overall safety of the combination therapy. Participants continue their usual diabetes care under their physician’s supervision. The study aims to describe real-world effectiveness and safety of the chiglitazar-SGLT-2 combination in routine practice.
Why it matters
Potential benefit: If successful, the approach could inform real-world treatment strategies for improving glycemic control and potentially reducing cardiovascular and renal risks in type 2 diabetes.
How similar studies have gone: Previous real-world studies of combination oral antidiabetic therapies have shown mixed results; this registry adds contemporary data on chiglitazar in combination with SGLT-2 inhibitors.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Beijing Hospital
Beijing, Beijing Municipality, China Recruiting -
West China Hospital of Sichuan University
Chengdu, Sichuan, China Recruiting
Study contacts
- Study coordinator: Wang
- Email: xinhwang@chipscreen.com
- Phone: +86 0755-36993550
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.