We present changes in glycemic control and weight with empagliflozin versus placebo in EMPA-REG OUTCOME based on two approaches, addressing the impact of additional glucose-lowering therapies introduced during the trial.Design and Method:
Patients with type 2 diabetes and high cardiovascular risk were randomized to receive empagliflozin 10 mg or 25 mg or placebo in addition to standard of care. Background glucose-lowering therapy was to remain unchanged for 12 weeks then could be adjusted according to local guidelines. We compared changes in HbA1c, fasting plasma glucose (FPG) and weight in all patients prior to receiving additional glucose-lowering therapy or changes in background glucose-lowering therapy versus all data obtained in all patients who were randomized and received at least one dose of study drug (modified intent-to-treat [ITT] approach).Results:
Of 7,020 treated patients, 54.2% and 32.5% in the placebo and empagliflozin groups, respectively, received additional or intensified glucose-lowering therapy. At week 12, comparable differences in HbA1c, FPG and weight were seen (table). However, interestingly, at week 164 there were only slight differences between the 2 approaches despite having the option to change glucose-lowering therapy.Conclusions:
In EMPA-REG OUTCOME, there were no clinically meaningful differences between analyses of glycemic control and weight that included or excluded changes in glucose-lowering therapy.