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NCT Number: NCT05307731

Fingolimod for Type 2 Diabetes Mellitus

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 .

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location status: Recruiting

Location contact

Hui-Sheng Chen, Ph.D.

CONTACT

[email protected]

+86 13352452086

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • patients with type 1 diabetes;
  • diabetic complications (ketoacidosis, hypertonic state, lactic acidosis).
  • Allergic to the study drug;
  • Abnormal liver and kidney function (transaminase greater than 2.5 times the upper limit of normal value; creatinine greater than 133umol / L);
  • 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;
  • Baseline QT interval extension (male > 450ms or female > 460ms);
  • Treatment with class IA or class III antiarrhythmic drugs;
  • Patients with systemic infection (including but not limited to bacteria, fungi, viruses, etc.);
  • Participating in other clinical trials within 3 months;
  • Other circumstances that the investigator considers unsuitable for participating in this clinical study.

Treatment and study plan

Fingolimod

Drug

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

guideline-based treatment for DM

Drug

guideline-based treatment for DM

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

    Time frame: 90 days, 120 days, 180 days

    including drug numbers and doses

  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

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

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

  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

Study contacts

Contact information is provided by the study sponsor or research team.

HuiSheng Chen

CONTACT

[email protected]

+8624897511

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2022
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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