The Influence of Oral Semaglutide for Vascular Inflammation in Japanese Patients with Type 2 Diabetes

Not Applicable

Recruiting

• Conditions: Patients with type 2 diabetes and a glycated hemoglobin level of 7% or more; type 2 diabetes

• Registration Number: JPRN-jRCTs071220027
• Lead Sponsor: Tahara Nobuhiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Patients with type 2 diabetes and a glycated hemoglobin level of 7% or more
2) Age of 18 to 90 years at screening and written informed consent to participate in this study
3) Age of less than 60 years with established cardiovascular disease, or age of 60 years or more with at least one cardiovascular risk factor
4) Oral hypoglycemic agents, lipid lowering agents, antihypertensive agents, and antiplatelet agents and doses of them unchanged within 90 days prior to screening
5) No treatment with any incretin-based antidiabetic agents (DPP-4 inhibitors or GLP-1 receptor agonists) within 90 days prior to screening

Exclusion Criteria

1. Patients with diabetic ketoacidosis or hyperglycemic hyperosmolar state
2. Patients with severe infection or surgical emergency
3. Patients with a history of hypersensitivity to study drugs
4. Pregnant patients
5. Patients with significant hepatic disorders or liver cirrhosis
6. Patients with a history of stomach resection
7. Patients with a fasting plasma glucose level of 200 mg/dL or more
8. Patients treated with insulin therapy
9. Patients with malignant neoplasms
10. Patients with active inflammatory diseases
11. Patients judged to be inappropriate to participate in this study by investigators
12. Patients treated with a DPP-4 inhibitor or a GLP-1 receptor agonist within 90 days before screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline after 6 months of treatment in vascular inflammation measured by blood-normalized standardized uptake value, known as a target-to-background ratio by FDG-PET/CT