A Practical Randomized Controlled Clinical Trial Protocol for the Use of Semaglutide in the Treatment of Peripheral Neuropathy in Type 2 Diabetes

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500096584

Enrollment

Unknown

Registered

2025-01-26

Start date

2025-03-01

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Type 2 diabetes

Interventions

Trial group:Mecobalamine tablets 500ug tid oral as the basic neuronutritional treatment, according to the patients tolerance, the dose of semiglutide starting from 0.25mg qw, gradually increasing the

Control group:Methobalamine tablets 500ug tid were given orally as the basic neuronutritional treatment, and semaglutide was not given

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) T2DM patients with DPN aged >=18 years and =19kg/m^2 and <=35kg/m^2 at screening time; (4) To participate in this study voluntarily, I sign a written informed consent.

Exclusion criteria

Exclusion criteria: (1) Neuropathy caused by other causes, such as multiple sclerosis, Parkinson's, cervical and lumbar diseases, Guillain-Barre syndrome, epilepsy, severe arteriovenous disease, etc.; (2) Contraindications for GLP-1RA use, including personal or family history of acute/chronic pancreatitis, multiple endocrine adenomatosis type 2 (MEN2), or medullary thyroid carcinoma (MTC), and clinically significant gastric empouting abnormalities (such as severe diabetic gastroparesis, gastric outlet obstruction, etc.); (3) GLP-1 RA has been used for more than 1 week in the past 3 months, GLP-1 RA has been used for more than 1 month within 1 year, and GLP-1 RA has been used for more than 3 months before 1 year; (4) A history of stroke, transient ischemic attack, unstable angina pectoris, or myocardial infarction in the 3 months prior to study inclusion; (5) A history of acute diabetic complications (diabetic ketoacidosis, lactic acidosis, or hyperosmolar hyperglycemia) within 6 months prior to screening; (6) A history of alcohol abuse or drug addiction; (7) Pregnant and lactating women.

Design outcomes

Primary

Measure	Time frame
Neural function;	—

Secondary

Measure	Time frame
DPN-related quality of life;	—

Countries

China

Contacts

Public ContactLingling Xu

Shenzhen Hospital, Southern Medical University

lucylingl@126.com+86 135 3883 8066

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026