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Clinical Trials in China / NCT05307731
Recruiting Phase 4

Fingolimod for Type 2 Diabetes Mellitus

NCT05307731 · tracked via the Priya Life Science China tracker
Sponsor
General Hospital of Shenyang Military Region
Phase
Phase 4
Started
2022-03-15
Last updated
2026-09-10

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

Fingolimodguideline-based treatment for DM

Fingolimod: 0.5mg daily for 90-180 days, in addition to guideline-based treatment for DM

guideline-based treatment for DM: guideline-based treatment for DM

Study summary

The aim of this study is to explore the efficacy and safety of Fingoland in the treatment of type 2 diabetes. A total of 40 patients were randomly divided into two groups. One group was treated with fingolimod, another group was given guideline based treatment. The changes of islet function in patients with glycosylated hemoglobin, insulin and C-peptide were observed .

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age: 18-70 years old; 2. clinically diagnosed type 2 diabetes. 3. Glycosylated hemoglobin: 6.5% - 9.5%; 4. No drug treatment or only one oral hypoglycemic drug within 6 months; 5. Fasting blood glucose: \< 13.9mmol/l for those without medication, or \< 13.3mmol/l for those with medication; 6. if the antidiabetic drugs are taken, the dosage and the drug must be stable in the past 3 months. 7. Body mass index (BMI) ≤ 45 kg / m2; 8. Sign informed consent Exclusion Criteria: 1. patients with type 1 diabetes; 2. diabetic complications (ketoacidosis, hypertonic state, lactic acidosis). 3. Allergic to the study drug; 4. Abnormal liver and kidney function (transaminase greater than 2.5 times the upper limit of normal value; creatinine greater than 133umol / L); 5. Complicated with other serious organ diseases; 6. Recent disease history (within the past 6 months): myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III / IV heart failure; 7. Presence or history of mobitz type II second or third degree AV block or sick sinus syndrome, unless the patient has a pacemaker; 8. Baseline QT interval extension (male \> 450ms or female \> 460ms); 9. Treatment with class IA or class III antiarrhythmic drugs; 10. Patients with systemic infection (including but not limited to bacteria, fungi, viruses, etc.); 11. Participating in other clinical trials within 3 months; 12. Other circumstances that the investigator considers unsuitable for participating in this clinical study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Neurology, General Hospital of Northern Theater Command Shenyang China Recruiting

More General Hospital of Shenyang Military Region trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05307731 on ClinicalTrials.gov ↗ ← All trials in China