NCT07580638Not yet recruiting
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
Chiglitazar Add-On to SGLT-2 Inhibitors in Patients With Type 2 Diabetes: A Nationwide, Multicenter Registry Study (C-STAR)
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 3550 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 18 Jul 2026
- Primary completion date
- 18 Jan 2028
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT07580638
What you commit to
- Study type: Observational
- Planned participants: 3550
- From 18 Jul 2026 to the primary completion date, 18 Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Presence of life-threatening comorbidities, severe edema, or severe hepatic impairment (Child-Pugh Class C).
Lab values
- Prior treatment with Chiglitazar Sodium.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.