Fingolimod for Type 2 Diabetes Mellitus

Phase 4

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Fingolimod; Drug: guideline-based treatment for DM

• Registration Number: NCT05307731
• Lead Sponsor: General Hospital of Shenyang Military Region

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fingoland group	Fingolimod	The patients of this group were treated with Fingolimod 0.5mg per day, in addition to guideline based treatment.
Fingoland group	guideline-based treatment for DM	The patients of this group were treated with Fingolimod 0.5mg per day, in addition to guideline based treatment.
Control group	guideline-based treatment for DM	The patients of this group were treated with diabetes drugs based on guideline

Primary Outcome Measures

Name	Time	Method
The changes of glycosylated hemoglobin, compared with baseline	180 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China