Are there any other possible disadvantages of taking part?
Although empagliflozin does not appear to cross the placenta, it is possible empagliflozin could affect an unborn child. Women who are pregnant, plan to get pregnant or are breast-feeding cannot join the study. Women who could become pregnant must agree to use highly effective contraception throughout the study and for a week after the end of the study (types of contraception which are considered highly effective are listed in the footnote below2).
If a participant becomes pregnant during the study (or wishes to do so), they should stop taking the study pills and tell the local study nurse or study doctor promptly so appropriate action can be taken.
If participants have private medical insurance or require travel insurance, their policy may be affected by joining the study, they should check this with with their insurance provider.
2Highly effective methods of contraception include implants, injections, combined oral contraceptive pills (started at least 3 months before joining the study), intrauterine devices (often known as a coils), vasectomised partner, or true and complete abstinence (i.e. not calendar or temperature methods).