Using Fingolimod to treat Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy and safety of Fingolimod in treating patients with Type 2 Diabetes Mellitus. A total of 40 participants will be randomly assigned to receive either Fingolimod or standard guideline-based treatment. The study will monitor changes in islet function, glycosylated hemoglobin levels, insulin, and C-peptide levels over the course of the intervention. The aim is to determine if Fingolimod can provide a beneficial effect compared to conventional treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: HuiSheng Chen, Ph.D — The General Hospital of Northern Theater Command
• Study coordinator: HuiSheng Chen
• Email: chszh@aliyun.com
• Phone: +8624897511

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.