臨床研究等提出・公開システム

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.)

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

Kentaro Watanabe

Nihon University Itabashi Hospital

30-1 Oyaguchi-kamicho, Itabashi

watanabe.kentaro@nihon-u.ac.jp

Kentaro Watanabe

Nihon University Itabashi Hospital

30-1 Oyaguchi-kamicho, Itabashi

+81-3-3972-8111

watanabe.kentaro@nihon-u.ac.jp

Recruiting

Nov. 17, 2025

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

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%

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

Both

Type 2 diabetes

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 be assigned to the oral semaglutide (Rybelsus) treatment group. An observation period of 1 to 2 months will be set after obtaining consent. Patients with HbA1c levels below 7.0% or above 10.0% at the end of the observation period will be excluded. At the start of treatment, dapagliflozin will be administered at 5 mg/day, and oral semaglutide at 3 mg/day. In the oral semaglutide group, the dosage will be increased to 7 mg/day after one month of treatment. The treatment period will last for three months.

Type 2 diabetes

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

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.

+81-3-3972-8111

Feb. 18, 2025

No

none