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Clinical Trial Summary

The aim of this works is to investigate the effect of genetic polymorphism of snps on human response to treatment with empagliflozine and its correlation with with pharmacokinetic parameters in Egyptian subjects

Clinical Trial Description

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, therefore resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia and also assists weight loss and blood pressure reduction. ABSORPTION Following oral administration, peak plasma concentrations were reached at 1.5 hours post-dose and then declined in a biphasic manner with a rapid distribution phase and a relatively slow terminal phase. Administration following a high-fat and high-calorie meal results in a slightly lower exposure with AUC decreasing by approximately 16% and Cmax decreasing by approximately 37% compared to fasted condition. METABOLISM In vitro studies suggest that empaglifozin is primarily metabolized by glucuronidation by 5'-diphospho-glucuronosyltransferases UG2B7, UGT1A3, UGT1A8, and UGT1A9. The most abundant metabolites are three glucuronide metabolites: 2-O-, 3-O-, and 6-O-glucuronide. Empagliflozin does not inhibit, inactivate, or induce CYP450 isoforms. It is a substrate for p-glycoprotein (p-gp), however in vitro studies suggest that it is unlikely to cause interactions with drugs that are p-gp substrates. After oral administration, empaglifozin was 41.2% eliminated in feces and 54.4% eliminated in urine. Terminal elimination half life was found to be 12.4 h based on population pharmacokinetic analysis. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05036421
Study type Interventional
Source Ain Shams University
Contact Sara M Shaheen
Phone +201008742248
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date September 1, 2021
Completion date February 2022

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