Using Fingolimod to treat Type 2 Diabetes
Fingolimod for Type 2 Diabetes Mellitus: a Pilot, Prospective, Randomized, and Open Label Single-center Study
This study is testing if Fingolimod can help people with Type 2 Diabetes manage their condition better than standard treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Locations | 1 site (Shenyang) |
| Trial ID | NCT05307731 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with clinically diagnosed Type 2 Diabetes and specific glycosylated hemoglobin levels.
Not a fit: Patients with Type 1 Diabetes or those with significant diabetic complications will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for managing Type 2 Diabetes Mellitus.
How similar studies have performed: While there is limited data on the use of Fingolimod for diabetes, similar studies exploring novel treatments for Type 2 Diabetes have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shenyang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.