Status:
RECRUITING
Fingolimod for Type 2 Diabetes Mellitus
Lead Sponsor:
General Hospital of Shenyang Military Region
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 f...
Eligibility Criteria
Inclusion
- Age: 18-70 years old;
- clinically diagnosed type 2 diabetes.
- Glycosylated hemoglobin: 6.5% - 9.5%;
- No drug treatment or only one oral hypoglycemic drug within 6 months;
- Fasting blood glucose: \< 13.9mmol/l for those without medication, or \< 13.3mmol/l for those with medication;
- if the antidiabetic drugs are taken, the dosage and the drug must be stable in the past 3 months.
- Body mass index (BMI) ≤ 45 kg / m2;
- Sign informed consent
Exclusion
- patients with type 1 diabetes;
- diabetic complications (ketoacidosis, hypertonic state, lactic acidosis).
- Allergic to the study drug;
- Abnormal liver and kidney function (transaminase greater than 2.5 times the upper limit of normal value; creatinine greater than 133umol / L);
- Complicated with other serious organ diseases;
- 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;
- Presence or history of mobitz type II second or third degree AV block or sick sinus syndrome, unless the patient has a pacemaker;
- Baseline QT interval extension (male \> 450ms or female \> 460ms);
- Treatment with class IA or class III antiarrhythmic drugs;
- Patients with systemic infection (including but not limited to bacteria, fungi, viruses, etc.);
- Participating in other clinical trials within 3 months;
- Other circumstances that the investigator considers unsuitable for participating in this clinical study.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05307731
Start Date
March 15 2022
End Date
March 15 2026
Last Update
August 21 2025
Active Locations (1)
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1
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China, 110016