Fingolimod for Type 2 Diabetes Mellitus
- NCT ID
- NCT05307731
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Phase 4
- Sponsor
- General Hospital of Shenyang Military Region
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 40 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following 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.
Study locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: China
Sample of listed locations
- Department of Neurology, General Hospital of Northern Theater Command — Shenyang, 110016, China — Site recruitment status not specified in the registry data
Study details
- Start date
- March 15, 2022
- Primary completion date
- March 15, 2028
- First posted
- April 1, 2022
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT05307731
- Registry last updated
- September 10, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT05307731 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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