Combination Therapy with an SGLT2 Inhibitor and a GLP-1 RA.

The influence of the combination of an SGLT2 inhibitor and a GLP-1 RA on Sirt1 gene expression. - Combination Therapy with an SGLT2 Inhibitor and a GLP-1 RA.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1031250503

Enrollment

Registered

2025-11-17

Start date

2025-11-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Type 2 diabetes

Interventions

Patients who have not been treated with an SGLT2 inhibitor will be assigned to the dapagliflozin (Forxiga) treatment group, while patients who have not been treated with a GLP-1 receptor agonist will

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with type 2 diabetes 2)Patients aged 20 to less than 85 years 3)Patients treated with a GLP-1 RA or a SGLT2 inhibitor for at least 3 months before baseline 4)Patients with HbA1c levels from 7.0% to less than 10.0%

Exclusion criteria

Exclusion criteria: 1)Patients with diabetes of causes other than type 2 diabetes 2)Patients receiving combination therapy with a GLP-1 receptor agonist and an SGLT2 inhibitor for more than 3 months before the start of the study 4)Patients with acute diseases, malignant diseases, chronic inflammatory diseases, collagen diseases, those undergoing steroid therapy, or those being treated with immunosuppressants 5)Patients with HbA1c levels below 7.0% or above 10.0% at the end of the observation period 6)Patients deemed inappropriate by the principal investigator or sub-investigators

Design outcomes

Primary

Measure	Time frame
The difference in Sirt1 gene expression in peripheral blood at the start of treatment and three months after treatment in all cases.	—

Secondary

Measure	Time frame
1)The difference in the gene expression levels of p53, Mcp1, Nlrp3, Foxo3, and Il-1be-ta in peripheral blood leukocytes, as well as Sirt1 activity, at the start of treatment and three months after treatment in all cases. 2)The difference in the gene expression levels of Sirt1, p53, Mcp1, Nlrp3, Foxo3, and Il-1be-ta in leukocytes, as well as Sirt1 activity, at the start of treatment and three months after treatment in the dapagliflozin or oral semaglutide treatment groups. 3)The difference in the gene expression levels of Sirt1, p53, Mcp1, Nlrp3, Foxo3, and Il-1be-ta, as well as Sirt1 activity, at the start of treatment or three months after treatment in the dapagliflozin or oral semaglutide treatment groups.	—

Measure

Time frame

1)The difference in the gene expression levels of p53, Mcp1, Nlrp3, Foxo3, and Il-1be-ta in peripheral blood leukocytes, as well as Sirt1 activity, at the start of treatment and three months after treatment in all cases. 2)The difference in the gene expression levels of Sirt1, p53, Mcp1, Nlrp3, Foxo3, and Il-1be-ta in leukocytes, as well as Sirt1 activity, at the start of treatment and three months after treatment in the dapagliflozin or oral semaglutide treatment groups. 3)The difference in the gene expression levels of Sirt1, p53, Mcp1, Nlrp3, Foxo3, and Il-1be-ta, as well as Sirt1 activity, at the start of treatment or three months after treatment in the dapagliflozin or oral semaglutide treatment groups.

—

Contacts

Public ContactWatanabe Kentaro

Nihon University Itabashi Hospital

watanabe.kentaro@nihon-u.ac.jp+81-3-3972-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026