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This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention & Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Active Comparator | This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. |
|
| Non-used drug | Placebo Comparator | This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10Mg Tab | Drug | This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention & Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome Measure | Patients who meet all inclusion criteria and none of the exclusion criteria and are not screen failures for reasons listed above will be randomized in a 1:1 ratio to either receive 10 mg per day dapagliflozin or enter control group at Visit 2. | 6 months |
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Inclusion criteria
For inclusion in the study patients should fulfil the following criteria:
3.30 or more mL/min/1.73 m2 of estimated glomerular filtration rate 4.Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study (from the time they sign consent) and for 1 month after the last dose of IP to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
5.Subjects who are blood donors should not donate blood during the study and for 1 month following their last dose of IP.
Exclusion criteria
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tzu Meng Weng | Contact | +886-2312-3456 | 66579 | wengmengtzu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NTUH | Recruiting | Taipei | Zhongzheng Dist. | 100229 | Taiwan |
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| Placebo | Drug | This trial is a randomized, open label, two-arm, parallel-group, non-used comparator, single center trial to evaluate the efficacy of dapagliflozin in subjects with Nonalcoholic fatty liver disease. This is a principal investigator initiate study. This study is supported by Liver Disease Prevention & Treatment Research Foundation. Dapagliflozin will be provided free of charge by AstraZeneca. |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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