NCT05307731 Fingolimod for Type 2 Diabetes Mellitus
| NCT ID | NCT05307731 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | General Hospital of Shenyang Military Region |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-03-15 |
| Primary Completion | 2026-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2022-03-15 with a primary completion date of 2026-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
HuiSheng Chen, Ph.D
PRINCIPAL INVESTIGATOR
The General Hospital of Northern Theater Command
Frequently Asked Questions
Who can join the NCT05307731 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05307731 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05307731 currently recruiting?
Yes, NCT05307731 is actively recruiting participants. Contact the research team at chszh@aliyun.com for enrollment information.
Where is the NCT05307731 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT05307731 clinical trial?
NCT05307731 is sponsored by General Hospital of Shenyang Military Region. The principal investigator is HuiSheng Chen, Ph.D at The General Hospital of Northern Theater Command. The trial plans to enroll 40 participants.
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