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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingoland group | Experimental | The patients of this group were treated with Fingolimod 0.5mg per day, in addition to guideline based treatment. |
|
| Control group | Active Comparator | The patients of this group were treated with diabetes drugs based on guideline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod | Drug | 0.5mg daily for 90-180 days, in addition to guideline-based treatment for DM |
|
| Measure | Description | Time Frame |
|---|---|---|
| The changes of glycosylated hemoglobin, compared with baseline | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of glycosylated hemoglobin, compared with baseline | 90 days, 120 days | |
| The changes of treatment drugs, compared with baseline | including drug numbers and doses | 90 days, 120 days, 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HuiSheng Chen | Contact | +8624897511 | chszh@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| HuiSheng Chen, Ph.D | The General Hospital of Northern Theater Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command | Recruiting | Shenyang | 110016 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| guideline-based treatment for DM | Drug | guideline-based treatment for DM |
|
| 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 | an oral glucose tolerance tests(OGTT) will be used to assess beta cell function. | 30 days, 90 days, 120 days, 180 days |
| 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 |
| D004700 | Endocrine System Diseases |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |