Diabetes Treatments Continue to Advance With New Data from Merck and Novo Nordisk
As a diabetes patient, Todd Hobbs, U.S. chief medical officer of Novo Nordisk, has been excited about all of the advancements in the space presented at the American Diabetes Association (ADA) 79th Scientific Sessions in San Francisco.
“Over the past few years there has been a good amount of information presented at ADA. This year though, with all of the data presented, this was the most exciting year,” Hobbs told BioSpace in an exclusive interview.
Over the weekend, Novo Nordisk presented data from three separate studies that highlighted the efficacy of its oral semaglutide, an investigational once-daily glucagon-like peptide-1 (GLP-1) analog in a pill. In the PIONEER 2 and 4 studies, oral semaglutide stood up against Eli Lilly’s Jardiance and Novo’s own Victoza.
In PIONEER 2, semaglutide demonstrated a superior A1C reduction of 1.3% compared to a 0.9% reduction with Jardiance at 26 weeks and a statistically significant reduction in A1C for the secondary endpoint at 52 weeks. In PIONEER 4, semaglutide demonstrated a non-inferior reduction in A1C versus Victoza and a superior reduction versus placebo at 26 weeks. At 52 weeks, semaglutide demonstrated statistically significant reductions in A1C against both Victoza and placebo, Novo Nordisk announced.
Hobbs said the data presented is exciting because it shows that an oral form of semaglutide can achieve the same results as an injectable.
“The goal was to reproduce an injectable profile in an oral. It hadn’t been done before and we wanted to do that in an oral fashion. The totality of the PIONEER (IIIa clinical program) shows we’ve been able to do that,” Hobbs said.
In addition to the PIONEER 2 and 4 data, Novo Nordisk also presented data from the PIONEER 6 trial that showed oral semaglutide demonstrated non-inferiority of major adverse cardiovascular events (MACE) versus placebo. The trial results are based on an accumulation of 137 first major adverse cardiovascular events and a median follow-up time of 16 months.
Novo Nordisk took the PIONEER data to the U.S. Food and Drug Administration in March hoping to seek regulatory approval. Armed with a Priority Review voucher, the company anticipates the regulatory authority to make a decision by mid- to late-September, Hobbs said. Hobbs noted that the company is also planning to seek additional label approval for semaglutide based on the MACE data but that will not be under the priority review.
Novo Nordisk certainly was not the only company to present data. Merck Research Labs presented data that showed the efficacy of Merck’s Januvia on type 2 diabetes patients age 65 and older in comparison to dapagliflozin, an SGLT2 inhibitor. Data showed that patients who took Januvia achieved better glycemic control and were more likely to reach their A1C goal. The study researchers noted that the farther patients were from their goal when their medication was intensified, the less likely they were to achieve it.
Sam Engel, associate vice president of diabetes, endocrinology and women’s health at Merck Research Laboratories, told BioSpace that the data will provide additional data for treatment of this patient population. Many of the patients in this age group have additional health issues that can impact treatment of type 2 diabetes. Therapies for diabetes are typically developed for broader patient populations, but Engel said it is critical for researchers to look at subpopulations of patients, such as those over the age of 65.
“Personalized treatment is an emerging theme in diabetes care. One size does not fit all,” Engel said. “This allows an individual provider to tailor therapy to a given patient.”
Over the past few years, Engel said there has been a “wealth” of advancements made in diabetes care but it helps providers to know the different options available when it comes to treating the disease.
“The evidence that is used to inform the tailored care decisions is usually lacking,” he said.