NCT05307731

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 .

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2022

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

March 21, 2022

Last Update Submit

August 20, 2025

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • The changes of glycosylated hemoglobin, compared with baseline

    180 days

Secondary Outcomes (8)

  • The changes of glycosylated hemoglobin, compared with baseline

    90 days, 120 days

  • The changes of treatment drugs, compared with baseline

    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

    30 days, 90 days, 120 days, 180 days

  • +3 more secondary outcomes

Study Arms (2)

Fingoland group

EXPERIMENTAL

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

Drug: FingolimodDrug: guideline-based treatment for DM

Control group

ACTIVE COMPARATOR

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

Drug: guideline-based treatment for DM

Interventions

FingolimodDRUG

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

Fingoland group
guideline-based treatment for DMDRUG

guideline-based treatment for DM

Control groupFingoland group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAmines

Study Officials

  • HuiSheng Chen, Ph.D

    The General Hospital of Northern Theater Command

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HuiSheng Chen

CONTACT

+8624897511chszh@aliyun.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 1, 2022

Study Start

March 15, 2022

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08

Locations

CN(1)