Study for the effects of once-daily semaglutid on glycemic control in patients with type 2 diabetes (SWITCH SEMA-2 study)

JRCT ID: jRCT1011210032

Registered date:26/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 14/10/2021
• Target sample size: 172
• Study type: Interventional
• Intervention(s): Continue DPP-4 inhibitors or switch to once daily semaglutide. Participants in the semaglutide group follow an escalation regimen of semaglutide 7-14 mg (maintenance dose reached after 4 weeks of 3 mg semaglutide once daily).

Outcome(s)

• Primary Outcome: The change in HbA1c at 24 weeks from baseline

Secondary Outcome

1) The change in the other blood and urinary tests
2) The change in weight, abdominal circumference, blood pressure and pulse
3) Adverse effects
4) The factors associated with improvement of HbA1c and secondary endopoints

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1) Age 20-90 years old
2) HbA1c 7.0-10.0%
3) BMI >= 18.5 kg/m2
4) patients who were treated with DPP-4 inhibitors at least for 12 weeks without discontinuation for more than 1 week (SItagliptin, teneligliptin, and anagliptin: from regular dose to maximun dose; vildagliptin, saxagliptin, trelagliptin, linagliptin, alogliptin, and omarigliptin: regular dose)
5) written informed consent

Exclude criteria

1) treatment with GLP-1 receptor agonists within past 12 weeks
2) history of anaphylaxis of semaglutide
3) unstable retinopathy
4) severe hepatic dysfunction or renal dysfunction
5) severe ketosis, diabetic coma
6) severe infection, surgery, serious trauma
7) female patients who are pregnant, lactating and/or willing to be pregnant, or male patients who wants to impregnate partner during study period
8) patients who are inadequate to enter this study due to the other reasons by physician's judgments

Related Information

• Primary Sponsor: Nomoto Hiroshi
• Secondary ID(s): UMIN000045270