Diabetes Mellitus, Type 2
Conditions
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 .
Interventions
DRUGFingolimod
0.5mg daily for 90-180 days, in addition to guideline-based treatment for DM
DRUGguideline-based treatment for DM
guideline-based treatment for DM
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes of glycosylated hemoglobin, compared with baseline | 180 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes of glycosylated hemoglobin, compared with baseline | 90 days, 120 days | — |
| The changes of treatment drugs, compared with baseline | 90 days, 120 days, 180 days | including drug numbers and doses |
| The changes of 2-hour postprandial blood glucose, compared with baseline | 30 days, 90 days, 120 days, 180 days | — |
| The changes of fasting blood glucose, compared with baseline | 30 days, 90 days, 120 days, 180 days | — |
| 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. |
| The changes of insulin, compared with baseline | 30 days, 90 days, 120 days, 180 days | — |
| The changes of C-peptide, compared with baseline | 30 days, 90 days, 120 days, 180 days | — |
| any adverse events | 180 days | — |
Countries
China
Contacts
CONTACTHuiSheng Chen
PRINCIPAL_INVESTIGATORHuiSheng Chen, Ph.D
The General Hospital of Northern Theater Command
Outcome results
None listed