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Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis & glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ertugliflozin | Experimental | Ertugliflozin 5/15mg once daily with standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertugliflozin 5 mg, 15mg | Drug | Ertugliflozin 5/15mg once daily in addition to standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiologic liver parameters | Number of participants reported change in liver fat content from baseline, as quantified by fibroscan | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c% levels compare with baseline in 6 months | Efficacy | up to 24 weeks |
| Change in body weight compare with baseline in 6 months | Body Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Nabeed Tahir, MBBS | Contact | +923015376299 | 2907 | nabeedtahir@getzpharma.com |
| Jahanzeb Kamal Khan, MBBS | Contact | +923201212945 | 8386 | jahanzeb.kamal@getzpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Umar Raja, MBBS | Shifa International Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North west general hospital | Recruiting | Peshawar | KPK | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29097281 | Background | Hu M, Phan F, Bourron O, Ferre P, Foufelle F. Steatosis and NASH in type 2 diabetes. Biochimie. 2017 Dec;143:37-41. doi: 10.1016/j.biochi.2017.10.019. Epub 2017 Oct 31. | |
| 27212244 | Background | Targher G, Byrne CD, Lonardo A, Zoppini G, Barbui C. Non-alcoholic fatty liver disease and risk of incident cardiovascular disease: A meta-analysis. J Hepatol. 2016 Sep;65(3):589-600. doi: 10.1016/j.jhep.2016.05.013. Epub 2016 May 17. |
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| up to 24 weeks |
| Change in waist circumference compare with baseline in 6 months | Waist Circumference | up to 24 weeks |
| Fibrosis 4 score levels compare with baseline in 6 months | Fibrosis Scoring < 1.45 indicates Fibrosis Stage 0-2, 1.45 to 3.25 is deemed indeterminate fibrosis stage, > 3.25 indicates Fibrosis stage 3-4 | up to 24 weeks |
| Non-Alchoholic Fatty Liver Disease Fibrosis Score levels compare with baseline in 6 months | Non-Alchoholic Fatty Liver Disease Fibrosis Scoring, < -1.455 indicates Fibrosis Stage 0-2, -1.455 to 0.676 is considered indeterminate fibrosis stage, > 0.676 indicates Fibrosis Stage 3-4 | up to 24 weeks |
| Frequency of adverse events in 6 months | Safety | up to 24 weeks |
| 29358469 | Background | Mantovani A, Byrne CD, Bonora E, Targher G. Nonalcoholic Fatty Liver Disease and Risk of Incident Type 2 Diabetes: A Meta-analysis. Diabetes Care. 2018 Feb;41(2):372-382. doi: 10.2337/dc17-1902. |
| 29137912 | Background | Mantovani A, Zaza G, Byrne CD, Lonardo A, Zoppini G, Bonora E, Targher G. Nonalcoholic fatty liver disease increases risk of incident chronic kidney disease: A systematic review and meta-analysis. Metabolism. 2018 Feb;79:64-76. doi: 10.1016/j.metabol.2017.11.003. Epub 2017 Nov 11. |
| 23855299 | Background | Schuppan D, Schattenberg JM. Non-alcoholic steatohepatitis: pathogenesis and novel therapeutic approaches. J Gastroenterol Hepatol. 2013 Aug;28 Suppl 1:68-76. doi: 10.1111/jgh.12212. |
| 25371775 | Background | Gusdon AM, Song KX, Qu S. Nonalcoholic Fatty liver disease: pathogenesis and therapeutics from a mitochondria-centric perspective. Oxid Med Cell Longev. 2014;2014:637027. doi: 10.1155/2014/637027. Epub 2014 Oct 13. |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008103 | Liver Cirrhosis |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C570288 | ertugliflozin |
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