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The purpose of this study is to investigate gut microbiota change and glucose lowering effect of initial combination therapy of gemigliptin and metformin compared to glimepiride and metformin in obese patients with type 2 diabetes.
Obese type 2 diabetes patients who were not treated with anti-diabetic medication within 6 weeks, were randomly assigned to gemigliptin/metformin or sulphonylurea/metformin. After 24 week treatment, gut microbiota composition change, glucose lowering effect, body weight, and gut hormones were compared between two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemigliptin/metformin | Experimental | zemimet-SR 50/1000 mg x 1 tablet |
|
| glimepiride/metformin | Active Comparator | amaryl-Mex 1/500 mg x 2 tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemigliptin/metformin | Drug | zemimet-SR 50/1000 mg x 1 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| gut microbiota composition change from baseline | Analysis of gut microbiota composition at class, genus, and species levels before and after treatment. Inter-individual changes of gut microbiota changes were analyzed. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change | HbA1c change from baseline to 24 weeks | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Using bioimpedance analysis, muscle mass and total and visceral fat mass were analyzed after 24 week treatment. | 24 weeks |
| Beta-cell function | HOMA-beta and insulinogenic index calculated before and after treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae Jung Oh | Seoul National University Bundang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C534891 | LC15-0444 |
| D008687 | Metformin |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| glimepiride/metformin | Drug | amaryl-Mex 1/500 mg x 2 tablets |
|
|
| 24 weeks |
| GLP-1 | Plasma levels of GLP-1 during 75g OGTT. | 24 weeks |
| GIP | Plasma levels of GIP during 75g OGTT. | 24 weeks |
| PYY | Plasma levels of PYY during 75g OGTT. | 24 weeks |