Diabetes
Conditions
Interventions
Experimental Group:Mecobalamin Tablets + Loxenatide/Add-on Insulin. Mecobalamin Tablets (0.5mg/tablet), oral administration, one tablet at a time, three times a day, may be adjusted according to age a
Control Group:Mecobalamin + Insulin. Mecobalamin Tablets (0.5mg/tablet), oral administration, one tablet at a time, three times a day, may be adjusted according to age and symptoms. Add or adjust insu
for those already using insulin, adjust the dose or regimen according to the condition, subcutaneous injection), continued for 3 months.
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 30 years and <=70 years; 2. Diagnosed with type 2 diabetes with poor glycemic control (6.5% < HbA1c < 10%); 3. Diagnosed with painful diabetic neuropathy based on physical examination or medical history, with a pain numerical rating scale score of 3-6; 4. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Taking antioxidant medications such as Vitamin E or Vitamin C; acute infections; hepatic insufficiency (ALT > 2.5 times the upper limit of normal or AST > 2.5 times the upper limit of normal); renal insufficiency (eGFR 160 mmHg or diastolic blood pressure > 100 mmHg). 6. Occurrence of diabetic ketosis, ketoacidosis, and severe infections within the last month. 7. Previously diagnosed depression patients who have been taking antidepressants for a long time; psychiatric patients without autonomous. 8. Pregnant, planning to become pregnant, or breastfeeding women. 9. History of multiple drug allergies or allergy to the components of this drug. 10. History or family history of medullary thyroid carcinoma, type 2 multiple endocrine neoplasia syndrome, congestive heart failure, inflammatory bowel disease, diabetic gastroparesis, acute pancreatitis, and frequent episodes of hypoglycemia (conditions where Loxenatide should not be used or used with caution). 11. Participation in clinical research within the last month. 12. Alcohol abuse and/or psychoactive substance use within the past 5 years, drug abusers and dependents. (Alcohol abuse behavior: according to the World Health Organization (WHO) alcohol consumption classification standard: beer > 750 mL·d?¹ or spirits > 10 mL·d?¹ or wine > 360 mL·d?¹). 13. Active eye disease, history of eye surgery, glaucoma, acute and chronic corneal diseases, long-term wearing of corneal contact lenses, etc. 14. Other pathologies or conditions that, in the judgment of the investigator, may reduce the likelihood of enrollment or complicate enrollment, such as frequently changing work environment, unstable living conditions, etc., which may easily lead to loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Toronto Clinical Scoring System (TCSS) was used to assess the changes in scores before and after administration, with the differences used for evaluation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in heart rate variability were evaluated using the difference method.;The changes in the Michigan Diabetic Neuropathy Score (MDNS) were evaluated using the difference method.;The changes in the Numerical Rating Scale for pain and the scores of the simplified McGill Pain Questionnaire were evaluated using the difference method.; | — |
Countries
China
Contacts
Public ContactLiu Xiaoxia
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed