Fingolimod for Type 2 Diabetes Mellitus

G

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)

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

Trial contacts and locations

1

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Central trial contact

HuiSheng Chen

Data sourced from clinicaltrials.gov

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