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Fingolimod for Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Fingolimod

guideline-based treatment for DM

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Neurology, General Hospital of Northern Theater CommandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fingoland group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The changes of glycosylated hemoglobin, compared with baseline

Secondary Outcome Measures

The changes of glycosylated hemoglobin, compared with baseline

The changes of treatment drugs, compared with baseline

including drug numbers and doses

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

The changes of fasting blood glucose, compared with baseline

Beta cell function, compared with baseline

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

The changes of insulin, compared with baseline

The changes of C-peptide, compared with baseline

any adverse events

Full Information

NCT ID

NCT05307731

First Posted

March 21, 2022

Last Updated

August 20, 2023

Sponsor

General Hospital of Shenyang Military Region

1. Study Identification

Unique Protocol Identification Number

NCT05307731

Brief Title

Fingolimod for Type 2 Diabetes Mellitus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2022 (Actual)

Primary Completion Date

March 15, 2024 (Anticipated)

Study Completion Date

March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

General Hospital of Shenyang Military Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fingoland group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Fingolimod

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

guideline-based treatment for DM

Intervention Description

guideline-based treatment for DM

Primary Outcome Measure Information:

Title

The changes of glycosylated hemoglobin, compared with baseline

Time Frame

180 days

Secondary Outcome Measure Information:

Title

The changes of glycosylated hemoglobin, compared with baseline

Time Frame

90 days, 120 days

Title

The changes of treatment drugs, compared with baseline

Description

including drug numbers and doses

Time Frame

90 days, 120 days, 180 days

Title

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

Time Frame