Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
40 participants
INTERVENTIONAL
2022-03-15
2026-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fingoland group
The patients of this group were treated with Fingolimod 0.5mg per day, in addition to guideline based treatment.
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
Control group
The patients of this group were treated with diabetes drugs based on guideline
guideline-based treatment for DM
guideline-based treatment for DM
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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General Hospital of Shenyang Military Region
OTHER
Responsible Party
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Hui-Sheng Chen
chief
Principal Investigators
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HuiSheng Chen, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The General Hospital of Northern Theater Command
Locations
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Department of Neurology, General Hospital of Northern Theater Command
Shenyang, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Y(2021)071
Identifier Type: -
Identifier Source: org_study_id
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