Fingolimod for Type 2 Diabetes Mellitus

Fingolimod for Type 2 Diabetes Mellitus: a Pilot, Prospective, Randomized, and Open Label Single-center Study

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 .

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Fingolimod; Drug: guideline-based treatment for DM

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: HuiSheng Chen; Phone Number: +8624897511; Email: chszh@aliyun.com

Study Locations

• China
  • Shenyang, China, 110016
    • Recruiting
    • Department of Neurology, General Hospital of Northern Theater Command
    • Contact: Hui-Sheng Chen, Ph.D.; Phone Number: +86 13352452086; Email: chszh@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fingoland group; The patients of this group were treated with Fingolimod 0.5mg per day, in addition to guideline based treatment.	Drug: Fingolimod; 0.5mg daily for 90-180 days, in addition to guideline-based treatment for DM; Drug: guideline-based treatment for DM; 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; guideline-based treatment for DM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The changes of glycosylated hemoglobin, compared with baseline	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of glycosylated hemoglobin, compared with baseline		90 days, 120 days
The changes of treatment drugs, compared with baseline	including drug numbers and doses	90 days, 120 days, 180 days
The changes of 2-hour postprandial blood glucose, compared with baseline		30 days, 90 days, 120 days, 180 days
The changes of fasting blood glucose, compared with baseline		30 days, 90 days, 120 days, 180 days
Beta cell function, compared with baseline	an oral glucose tolerance tests(OGTT) will be used to assess beta cell function.	30 days, 90 days, 120 days, 180 days
The changes of insulin, compared with baseline		30 days, 90 days, 120 days, 180 days
The changes of C-peptide, compared with baseline		30 days, 90 days, 120 days, 180 days
any adverse events		180 days

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Investigators: Principal Investigator: HuiSheng Chen, Ph.D, The General Hospital of Northern Theater Command

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Sphingosine 1 Phosphate Receptor Modulators; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fingolimod Hydrochloride
• Other Study ID Numbers: Y(2021)071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No