Fingolimod for Type 2 Diabetes Mellitus

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase: Enrolling; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: guideline-based treatment for DM; Drug: Fingolimod

Study type: Interventional

Funder types: Other

Identifiers

NCT05307731

Y(2021)071

Details and patient eligibility

About

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 .

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Fingoland group

Experimental group

Description:

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

Treatment:

Drug: guideline-based treatment for DM

Drug: Fingolimod

Control group

Active Comparator group

Description:

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

Treatment:

Drug: guideline-based treatment for DM