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RecruitingNCT05307731Updated Sep 10, 2026

Fingolimod for Type 2 Diabetes Mellitus

A Phase 4 interventional study of Fingolimod and guideline-based treatment for DM in Diabetes Mellitus, Type 2, sponsored by General Hospital of Shenyang Military Region. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by General Hospital of Shenyang Military Region · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2022; still recruiting 4 years 6 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 .

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Fingoland group

    The patients of this group were treated with Fingolimod 0.5mg per day, in addition to guideline based treatment.

    Drug: Fingolimod · Drug: guideline-based treatment for DM

  • Active comparator
    Control group

    The patients of this group were treated with diabetes drugs based on guideline

    Drug: guideline-based treatment for DM

Interventions

  • DrugFingolimod

    0.5mg daily for 90-180 days, in addition to guideline-based treatment for DM

  • Drugguideline-based treatment for DM

    guideline-based treatment for DM

06

What researchers measure

Primary outcomes

  1. The changes of glycosylated hemoglobin, compared with baseline

    Time frame: 180 days

Secondary outcomes

  1. The changes of glycosylated hemoglobin, compared with baseline

    Time frame: 90 days, 120 days

  2. The changes of treatment drugs, compared with baseline

    including drug numbers and doses

    Time frame: 90 days, 120 days, 180 days

  3. The changes of 2-hour postprandial blood glucose, compared with baseline

    Time frame: 30 days, 90 days, 120 days, 180 days

  4. The changes of fasting blood glucose, compared with baseline

    Time frame: 30 days, 90 days, 120 days, 180 days

  5. Beta cell function, compared with baseline

    an oral glucose tolerance tests(OGTT) will be used to assess beta cell function.

    Time frame: 30 days, 90 days, 120 days, 180 days

  6. The changes of insulin, compared with baseline

    Time frame: 30 days, 90 days, 120 days, 180 days

  7. The changes of C-peptide, compared with baseline

    Time frame: 30 days, 90 days, 120 days, 180 days

  8. any adverse events

    Time frame: 180 days

07

Study locations

1 of 1 sites recruiting
  • Department of Neurology, General Hospital of Northern Theater Command
    Shenyang, 110016, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05307731
Lead sponsor
General Hospital of Shenyang Military Region
Responsible party
Hui-Sheng Chen (chief, General Hospital of Shenyang Military Region) — Principal investigator
First posted
Apr 1, 2022
Start date
Mar 15, 2022
Primary completion
Mar 15, 2028 (estimated)
Completion
Mar 15, 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

HuiSheng Chen
Contact
chszh@aliyun.com
+8624897511
HuiSheng Chen, Ph.D
principal investigator · The General Hospital of Northern Theater Command

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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