Clinical trial NCT05307731: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: The changes of glycosylated hemoglobin, compared with baseline
timeFrame: 180 days
Secondary outcomes:
measure: The changes of glycosylated hemoglobin, compared with baseline
timeFrame: 90 days, 120 days
measure: The changes of treatment drugs, compared with baseline
timeFrame: 90 days, 120 days, 180 days
measure: The changes of 2-hour postprandial blood glucose, compared with baseline
timeFrame: 30 days, 90 days, 120 days, 180 days
measure: The changes of fasting blood glucose, compared with baseline
timeFrame: 30 days, 90 days, 120 days, 180 days
measure: Beta cell function, compared with baseline
timeFrame: 30 days, 90 days, 120 days, 180 days
measure: The changes of insulin, compared with baseline
timeFrame: 30 days, 90 days, 120 days, 180 days
measure: The changes of C-peptide, compared with baseline
timeFrame: 30 days, 90 days, 120 days, 180 days
measure: any adverse events
timeFrame: 180 days
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: HuiSheng Chen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: