Tan, Susanne, Schellenberg, Doerte, Morton, Kayce, Dokras, Anuja, Seufert, Joachim, Zwanziger, Denise, Dunschen, Karin, Zakaria, Marjorie, Huseinovic, Neda, Basson, Craig, Fuhrer, Dagmar and Hinder, Markus (2021) Licogliflozin versus placebo in women with polycystic ovary syndrome: A randomized, double-blind, phase 2 trial. Diabetes, Obesity and Metabolism. pp. 1-5. ISSN 14631326

Abstract

Polycystic ovary syndrome (PCOS) is characterized by hyperandrogenism and insulin resistance. The dual sodium-glucose co-transporter 1/2 inhibitor (SGLT1/2i) licogliflozin (LIK066) ameliorates hyperinsulinism in patients with diabetes and obesity. This study examines the effect of licogliflozin on androgens in women with PCOS. In a multicentre, randomized, placebo-controlled, double-blind, 2-week trial, patients with PCOS received licogliflozin 50 mg or placebo three times a day (TID). Changes in free testosterone (FT), other androgens and variables of insulin resistance were analysed. Concentration of FT did not change (TRLIK066:TRPCB [FT]: 0.88; 90% CI: 0.70-1.11; P =.353). Licogliflozin reduced androstendione (A4) by 19% (TRLIK066:TRPCB [A4]: 0.81; 90% CI: 0.68-0.99; P =.089) and dehydroepiandrosteron sulphate (DHEAS) by 24% (TRLIK066:TRPCB [DHEAS]: 0.76; 90% CI: 0.65-0.89; P =.008). Hyperinsulinaemia was reduced by 70% by licogliflozin (highest insulin concentration [MAXI]; TRLIK066:TRPCB [MAXI]: 0·26; 90% CI:0.20-0.34; P <.001 and area under the curve insulin [AUCI]; TRLIK066:TRPCB [AUCI]: 0.32; 90% CI: 0.25-0.41; P <.001). Diarrhoea and nausea occurred as common adverse events. Dual inhibition of SGLT1/2 ameliorates hyperinsulinaemia and hyperandrogenaemia in women with PCOS. Licogliflozin may represent a promising novel treatment option for PCOS.

Item Type:	Article
Keywords:	antidiabetic drug clinical trial drug mechanism endocrine therapy phase I-II study SGLT2 inhibitor
Date Deposited:	24 Aug 2021 00:45
Last Modified:	24 Aug 2021 00:45
URI:	https://oak.novartis.com/id/eprint/45205