Health TrialsbyHealthPanel

Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes

ConditionT2DM (Type 2 Diabetes Mellitus)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorChipscreen Biosciences, Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

T2DM patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

3,550 Participants
are divided into 2 treatment groups
Group A: Chiglitazar Cohort (Exposure Group)1 intervention
Group B: Comparator Cohort (Control Group)1 intervention

Trial outcomes

Primary outcomes

1

Glycated Hemoglobin (HbA1c)

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

Time frame
Baseline, 6 Months

Secondary outcomes

1

N-terminal pro-B-type natriuretic peptide

To assess the change from baseline in N-terminal pro-B-type natriuretic peptide

Time frame
Baseline, 6 Months, 12 Months
2

High-sensitivity C-reactive Protein

To assess the change from baseline in High-sensitivity C-reactive Protein

Time frame
Baseline, 6 Months, 12 Months
3

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).

Time frame
Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
4

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.

Time frame
Baseline, 6 Months, 12 Months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chipscreen Biosciences, Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: