ADA: Lilly, Boehringer's DPP-4 drug Tradjenta ties generic rival in heart safety study

Boehringer Ingelheim and Eli Lilly have already shown that Tradjenta doesn’t hurt patients’ hearts. But the pair is back with even more supporting evidence that they hope will bolster the drug's profile in a competitive field.

Monday at the American Diabetes Association annual meeting, the companies rolled out results showing Tradjenta didn’t increase cardiovascular risks for Type 2 diabetes patients when pitted against generically available glimepiride.

And when it came to preventing low blood sugar and spurring weight loss, Tradjenta registered wins. The study, called Carolina, showed Tradjenta could cut the relative risk of hypoglycemia by 77% over glimepiride and trigger a 1.5 kg weight reduction, too.

The results follow data from a separate trial, dubbed Carmelina, unveiled last October. That study showed Tradjenta was no worse than placebo for Type 2 diabetes’ patients’ hearts.

But the new trial was the first to test a member of Tradjenta’s class of DPP-4 inhibitors against an active comparator, the pharmas noted. It also tracked safety over the longest period ever studied in a DPP-4 CV outcomes trial at more than six years.

The way Lilly and BI see it, they can’t have too much cardiovascular data for Tradjenta, which is fighting for a place in the diabetes treatment landscape among drugs that have shown not only that they’re safe for the heart, but can confer cardiovascular benefits, too.

"When you treat people with diabetes, you only want to use medications that don’t cause harm overall," but also "have a proven and established safety and cardiovascular" track record, Mohamed Eid, Boehringer's VP of clinical development and medical affairs, said.

And those companies would know. Jardiance, their shared SGLT2 inhibitor, was the first-ever diabetes medicine to demonstrate that it could help patients’ hearts, a finding that’s raised the bar for diabetes drugmakers across the board. For patients with established CV disease, the American College of Cardiology and American Diabetes Association now recommend doctors prescribe therapies with proven CV benefits, Jeff Emmick, Lilly Diabetes’ VP of product development, said in a press release.

But that doesn’t mean there’s no place for Tradjenta and its peers. "Physicians considering additional therapies to lower blood glucose for their patients need a DPP-4 inhibitor with an established long-term safety profile. This new data … expands the evidence and experience with Tradjenta, to provide healthcare professionals with confidence in the long-term safety profile across a broad range of patients," Emmick added.

Sales of the drug increased by 7% between 2017 and 2018, hitting $574.7 million worldwide.