Fingolimod for Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307731
• Other study ID #: Y(2021)071
• Status: Recruiting
• Phase: Phase 4
• Start date: March 15, 2022
• Est. completion date: March 15, 2024

Study information

• Verified date: August 2023
• Source: General Hospital of Shenyang Military Region
• Contact: HuiSheng Chen
• Phone: +8624897511
• Email: chszh[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
China	Department of Neurology, General Hospital of Northern Theater Command	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of glycosylated hemoglobin, compared with baseline		180 days
Secondary	The changes of glycosylated hemoglobin, compared with baseline		90 days, 120 days
Secondary	The changes of treatment drugs, compared with baseline	including drug numbers and doses	90 days, 120 days, 180 days
Secondary	The changes of 2-hour postprandial blood glucose, compared with baseline		30 days, 90 days, 120 days, 180 days
Secondary	The changes of fasting blood glucose, compared with baseline		30 days, 90 days, 120 days, 180 days
Secondary	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
Secondary	The changes of insulin, compared with baseline		30 days, 90 days, 120 days, 180 days
Secondary	The changes of C-peptide, compared with baseline		30 days, 90 days, 120 days, 180 days
Secondary	any adverse events		180 days