Fingolimod for Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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 .

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Fingolimod
* Drug: guideline-based treatment for DM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fingoland group<br>The patients of this group were treated with Fingolimod 0.5mg per day, in addition to guideline based treatment. | Drug: Fingolimod<br>* 0.5mg daily for 90-180 days, in addition to guideline-based treatment for DM<br>Drug: guideline-based treatment for DM<br>* guideline-based treatment for DM<br>|
| Active Comparator: Control group<br>The patients of this group were treated with diabetes drugs based on guideline | Drug: guideline-based treatment for DM<br>* guideline-based treatment for DM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of glycosylated hemoglobin, compared with baseline |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of glycosylated hemoglobin, compared with baseline |  | 90 days, 120 days | 
| The changes of treatment drugs, compared with baseline | including drug numbers and doses | 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 | an oral glucose tolerance tests(OGTT) will be used to assess beta cell function. | 30 days, 90 days, 120 days, 180 days | 
| The changes of insulin, 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 |