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Most treatments have side effects, which some people may experience, and others may not.

EMPA-KIDNEY is testing empagliflozin, which has already been tested in over 8,000 people. Among these people, it has been generally well-tolerated. It now has a licence from health regulators for use in some types of people who already have type 2 diabetes.

Nevertheless participants may experience some symptoms when taking empagliflozin which come from the way the drug works in the body. For example, empagliflozin causes increase salt and water loss into the urine and some people report noticing a need to pass urine more often. Some have reported symptoms suggestive of dehydration, such as increased levels of thirst or feeling faint. It may be necessary to change some of a participants other pills to compensate. Such symptoms (and other common symptoms) may also happen if participants are on the inactive pill (placebo), as they are common in people being treated for a kidney problem or diabetes.

For people with diabetes, there is a risk of a condition called ketoacidosis. If a potential participant has had ketoacidosis in the last 5 years they cannot join the study. Ketones build up if there is too little insulin in the body, a situation which also leads to persistently high levels of blood sugar. When taking empagliflozin, ketoacidosis can develop without blood sugar levels being particularly high. The symptoms of ketoacidosis are non-specific, including feeling or being sick, tummy ache and shortness of breath. Others may notice the smell of pear drops or nail varnish on the breath. Ketoacidosis is treated with increased insulin and fluid intake. Hospital treatment with a drip and insulin may be needed. There is extra information available on ketones in a separate information leaflet for those participants with diabetes.

As with all medicines, some people can develop an allergic reaction, including itchy skin or a skin rash. Very rarely, some people may require immediate treatment in a hospital or emergency room for swelling around the mouth and throat causing difficulty in breathing.

Local doctors may also notice that kidney function slightly decreases on starting empagliflozin. This may be transient and may not be a bad thing as it may be a sign of the protective effect of empagliflozin (or perhaps just natural changes in kidney function). They may also notice a slight increase in the concentrations of cholesterol and red blood cells in the blood.

Throughout the study, the research team will carefully monitor participants and their blood tests for possible side effects. Some side effects may necessitate study pills to be stopped temporarily or permanently.

The study research nurse will keep participants up to date with any new important information we learn about the pills.

If participants do experience unexpected symptoms and want to ask questions, they can contact their local study research nurse, or an EMPA-KIDNEY study doctor based in Oxford, on Freefone 0808 164 4060 (available 24 hours a day, 7 days a week).

Empagliflozin also works by increasing sugar in the urine. This can occasionally cause pain on passing urine and/or increase the chance of a urine or genital tract infection, like thrush. Confirmed infections are usually easily treated with a course of antibiotics or antifungal pills. If such treatment is ever needed, a GP or local study team could help diagnose and treat it.

Low blood sugar may also occur in people with diabetes who are already taking insulin or certain diabetes pills (like gliclazide). Common low blood sugar symptoms include: sweating, shakiness, hunger, restlessness, slurred speech, and confusion. A sugary drink normally reverses the problem.