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Fingolimod for Type 2 Diabetes Mellitus

Sponsor
General Hospital of Shenyang Military Region (Other)
Overall Status
Recruiting
CT.gov ID
NCT05307731
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Fingolimod for Type 2 Diabetes Mellitus: a Pilot, Prospective, Randomized, and Open Label Single-center Study
Actual Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Mar 15, 2023
Anticipated Study Completion Date :
Mar 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fingoland group

The patients of this group were treated with Fingolimod 0.5mg per day, in addition to guideline based treatment.

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

Drug: guideline-based treatment for DM
guideline-based treatment for DM
Active Comparator: Control group

The patients of this group were treated with diabetes drugs based on guideline

Drug: guideline-based treatment for DM
guideline-based treatment for DM

Outcome Measures

Primary Outcome Measures

  1. The changes of glycosylated hemoglobin, compared with baseline [180 days]

Secondary Outcome Measures

  1. The changes of glycosylated hemoglobin, compared with baseline [90 days, 120 days]

  2. The changes of treatment drugs, compared with baseline [90 days, 120 days, 180 days]

    including drug numbers and doses

  3. The changes of 2-hour postprandial blood glucose, compared with baseline [30 days, 90 days, 120 days, 180 days]

  4. The changes of fasting blood glucose, compared with baseline [30 days, 90 days, 120 days, 180 days]

  5. 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.

  6. The changes of insulin, compared with baseline [30 days, 90 days, 120 days, 180 days]

  7. The changes of C-peptide, compared with baseline [30 days, 90 days, 120 days, 180 days]

  8. any adverse events [180 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Neurology, General Hospital of Northern Theater Command Shenyang China 110016

Sponsors and Collaborators

  • General Hospital of Shenyang Military Region

Investigators

  • Principal Investigator: HuiSheng Chen, Ph.D, The General Hospital of Northern Theater Command

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hui-Sheng Chen, chief, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier:
NCT05307731
Other Study ID Numbers:
  • Y(2021)071
First Posted:
Apr 1, 2022
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Fingolimod Hydrochloride

Study Results

No Results Posted as of Apr 1, 2022