- Merck and Pfizer are expanding the size of a key clinical trial aimed at demonstrating the cardiovascular benefit of ertugliflozin, an experimental SGLT-2 inhibitor in development for treatment of type 2 diabetes, the companies said over the weekend.
- Ertugliflozin also met its primary endpoints in two phase 3 trials testing the drug as a monotherapy and in combination with Merck’s Januvia (a DPP-4 inhibitor). Both treatments led to a statistically significant reduction in average blood glucose.
- The two drug companies plan to submit applications for both ertugliflozin and the combination treatment to the FDA by the end of 2016.
Competition has ramped up in the growing global diabetes market, which is estimated to be worth over $70 billion, according to figures cited by Bloomberg. Januvia has been a blockbuster drug for Merck, but sales have leveled off in recent years.
And the pressure to demonstrate a cardiovascular benefit has increased sharply since Eli Lilly and Boehringer Ingelheim demonstrated a positive effect from their drug Jardiance.
The Danish company Novo Nordisk also recently unveiled data on its new drug Victoza which showed a 13% reduction in the risk of heart attack, stroke, and cardiovascular death following treatment.
Around half of deaths in patients with diabetes stem from heart disease, leading companies to study the effect of their drugs on cardiovascular risk.
Pfizer wants to ramp up its presence in the diabetes market in order to better compete, partnering with Merck in 2013 to advance ertugliflozin.
In a placebo-controlled trial of patients with type 2 diabetes, ertugliflozin significantly reduced a measure of average blood glucose, known as A1C, by .99% to 1.16%. Weight loss was also statistically significant and the safety profile compared favorably to placebo treatment.
Data from the second study showed treatment with ertugliflozin and Januvia was more effective than either ertuglifozin or Januvia alone.
Overall, Merck and Pfizer will run nine phase 3 trials in roughly 12,600 adults with type 2 diabetes as part of ertugliflozin’s clinical development.