Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes

NCT07580638 | Not Yet Recruiting

• 1 other identifier: CGZ401
• Study Type: observational
• Target: 3,550
• Locations: 0 countries
• Sites: N/A

Brief 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) . 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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

• Glycated Hemoglobin (HbA1c)

  Change From Baseline in Glycated Hemoglobin (HbA1c) at 6 Months

  Baseline, 6 Months

Secondary Outcomes (23)

• N-terminal pro-B-type natriuretic peptide

  Baseline, 6 Months, 12 Months

• 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).

  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

  Baseline, 6 Months, 12 Months.

• Resolution Rate of Metabolic Syndrome

  6 Months, 12 Months.

Study Arms (2)

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).

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)

Drug: SGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs)

Interventions

SGLT-2 inhibitor and Chiglitazar DRUG

Prescribed as an add-on therapy to an SGLT-2 inhibitor-based regimen according to the physician's clinical judgment and routine practice

Chiglitazar Cohort (Exposure Group)

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.

Comparator Cohort (Control Group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

T2DM patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors; chiglitazar

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): July 18, 2026
• Primary Completion (Estimated): January 18, 2028
• Study Completion (Estimated): July 18, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share