NCT05307731RecruitingPhase 4
Fingolimod for Type 2 Diabetes Mellitus
Fingolimod for Type 2 Diabetes Mellitus: a Pilot, Prospective, Randomized, and Open Label Single-center Study
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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 .
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 21 Mar 2022
- Start date
- 15 Mar 2022
- Primary completion date
- 15 Mar 2028
- Lead sponsor
- General Hospital of Shenyang Military Region
- Diseases
- Type 2 diabetes
- NCT number
- NCT05307731
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 15 Mar 2022 to the primary completion date, 15 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with class IA or class III antiarrhythmic drugs;
Other illness
- patients with type 1 diabetes;
- Allergic to the study drug;
- 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;
- Patients with systemic infection (including but not limited to bacteria, fungi, viruses, etc.);
Lab values
- Abnormal liver and kidney function (transaminase greater than 2.5 times the upper limit of normal value; creatinine greater than 133umol / L);
- Baseline QT interval extension (male \> 450ms or female \> 460ms);
Other
- diabetic complications (ketoacidosis, hypertonic state, lactic acidosis).
- Participating in other clinical trials within 3 months;
- Other circumstances that the investigator considers unsuitable for participating in this clinical study.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.