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2016 ADA 76th Scientific Sessions Rundown, Part 2

Part 2 of our ADA Rundown checks out the latest information on competing long-acting insulins, and the ongoing research into potential class effect benefits for cardiovascular outcomes: as data shows CV benefits for DPP-4 and SGLT-2 treatments, are GLP-1 treatments under pressure? (Go to Part 1 of this article.)

Novo Nordisk’s next-generation long acting basal insulin Tresiba has a tough task: To take market share from the long-dominant Sanofi product Lantus, at a time when Sanofi has its own follow-on product Toujeo in the mix. Novo thinks it has an advantage, though. In two late-stage studies, Tresiba patients suffered fewer episodes of hypoglycemia — a feared risk of insulin treatment — compared with Sanofi’s blockbuster.

Sanofi’s Toujeo earned good marks in a real-word study of patients who switched to the new long-acting product from another basal insulin. Type 2 diabetes patients in the study successfully switched to Toujeo, with improvements to their A1C numbers and hypoglycemia risks. The SWITCH-1 and SWITCH-2 studies showed that the Novo product Tresiba significantly lowered rates of hypoglycemia in comparison with the Sanofi drug, while matching it at controlling blood sugar. The advantage for Tresiba was larger in Type 2, where patients taking the drug saw a 30% lower rate of hypoglycemic episodes, including a 42% drop in the rate of nighttime episodes. The reduction in severe hypoglycemia was even larger, with a 51% rate reduction for fully treated patients.  When Tresiba won approval last September, the FDA did not include Tresiba’s benefits on the hypoglycemia side, so Novo wasn’t able to tout that advantage in its launch earlier this year. The SWITCH data might change the agency’s mind on that, opening the door for ads targeting that safety edge.

Takeda already knew from 2013 results of a cardiovascular outcomes trial that its Type 2 diabetes med, Nesina, didn’t increase the risk of CV events for ACS patients when compared with placebo. But now it knows the same is true of the risk of death. Among Type 2 diabetes patients with ACS, death from any cause occurred in 5.7% of patients in the EXAMINE trial’s Nesina arm, compared with 6.5% of those taking placebo, according to a post hoc analysis presented. Their Actos Drug is now off patent and that drug alone took in more than 16 billion dollars over its lifetime. Plus, Nesina — along with related combo meds Kazano and Oseni, which join active ingredient alogliptin with metformin and Actos API pioglitazone, respectively — was hardly the first to hit the DPP-4 scene, which is dominated by Merck’s Januvia.

The entire DPP-4 class is feeling the heat thanks to meds from rival classes that recently demonstrated they could do more in the CV department. Last year, Eli Lilly and Boehringer Ingelheim’s SGLT-2 inhibitor, Jardiance, became the first diabetes drug to show it could actually provide a cardiac benefit, cutting down on the combined risk of CV death, heart attack and stroke. And more recently, Novo Nordisk’s  GLP-1 Victoza accomplished the same feat, and data was presented on how well it performed.

AstraZeneca is trumpeting positive data from a pair of analyses on SGLT-2 contender Farxiga. In one, researchers found that Farxiga recorded a decrease in body weight and blood pressure among patients with kidney problems that was similar to the decreases it posted among those with mild renal impairment or normal kidney function. And in the other, Farxiga — when administered alongside a potassium-sparing diuretic — cut down A1C, body weight and blood pressure without significantly upping potassium levels, researchers found, eliminating the potential for the hyperkalemia concerns that have surrounded its rival Invokana.

Jim McDermott, AZ’s head of U.S. medical affairs for its diabetes unit, added that, “SGLT-2s diminish in terms of their ability to lower glucose as renal function decreases, so what we wanted to do was see if there were attributes or benefits besides just lowering blood glucose.” Hiddo Lambers Heerspink, lead investigator, said in a statement that this is really good news, as the evidence suggests there are about 1 in 3 adults with diabetes who exhibit renal impairment. And in addition, “excretion was actually still high” in patients with renal impairment, suggesting the potential of a renal benefit for Farxiga. “You’d have to do a renal outcomes trial” to really establish that benefit, McDermott said — something AstraZeneca is talking about launching — but the data provided a “nice signal.”

So stay tuned for the next few newsletters which will go into more detail. We’ll also share a number of exclusive video interviews we conducted at ADA as well as the 2016 AACE meeting. These will provide new information that we promise you have not heard yet!