We will compare the health and quality of life of participants given Sotagliflozin with participants given a placebo. A placebo is a tablet that looks the same as Sotagliflozin but is not an active medicine (dummy medicine). Participants won’t be able to choose whether they receive the Sotagliflozin tablets or the placebo tablets, this will be decided in a random way (a bit like tossing a coin but done by a computer). Neither the participant, nurse or doctor will be told if the participant is receiving the Sotagliflozin or placebo. Participants will not be able to ask to find this out, but we’ll tell them once the trial is finished and the results of the trial are published. In an emergency, if a doctor looking after the participant needs to know what treatment they are receiving, for their safety, they’ll be able to ask for this information. To take part in the trial participants have to be happy to receive either the Sotagliflozin tablets or the placebo tablets.
Participants will be given the Sotagliflozin 200 mg or placebo tablets to take once per day for 4 months.
Participants will continue to take their usual medications as directed. Taking the trial tablets may mean that they need to adjust their regular insulin dose but their trial doctor or nurse will discuss this with them.