Prof. Marx (Aachen, Germany)

As you can see in the Kaplan–Meier curve, linagliptin does not increase CV risk compared with glimepiride here with superimposing curves here for linagliptin or glimepiride.

When we look at all the single endpoints all on the line of unity, so no signal into one or the other direction here and if we look at subgroups here: very consistent findings no matter whether they had a low or high eGFR, HbA_1c levels, age or gender.

In addition, we looked at all-cause mortality and showed that linagliptin did not increase the risk of all-cause mortality compared with glimepiride.

In addition, again, looking at heart failure-related outcomes, we saw no significant difference between the two groups.

I mentioned that we looked at the secondary endpoints here, and we could show that more patients receiving linagliptin achieved the HbA_1c goal of ≤7.0% without moderate or severe hypoglycaemia and without the need for rescue medication, as you can see here.

With respect to HbA_1c -lowering, there’s no meaningful difference between the two drugs here – this is an MMRM analysis here. You see the initial drop with sulphonylurea – this is known – but over time here, no difference in HbA_1c. 

But we saw a major difference with respect to hypoglycaemic events (as shown here for any hypoglycaemic events for glimepiride in green and linagliptin in blue) and also for moderate or severe hypoglycaemia, major difference in favour of linagliptin showing a tremendous reduction of hypoglycaemic events. Summarising: approximately 1 in 3 patients receiving glimepiride experienced moderate-to-severe hypoglycaemia.

Let’s look at weight gain: I mentioned that sulphonylurea treatment patients usually gain some weight and there was a mean difference of 1.5 kg between the two groups [linagliptin and glimepiride].