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2016 ADA 76th Scientific Sessions Rundown, Part 1

In part 1 of our ADA Rundown, we look at cardiovascular benefits for multiple drugs, new combination treatments, and the possibility that Invokana’s weight loss benefits may also apply to people who don’t have diabetes.

NEW ORLEANS–Diabetes researchers, endocrinologists and primary care docs, patient advocacy groups and, of course, media, all came to this city over the weekend to catch the latest data on diabetes.  There was so much great information that we decided to give you a brief overview of some of the most important; over the next few weeks, we’ll continue to provide coverage in more detail, so as not to overwhelm you.

This is truly an exciting time for treatments for diabetes. If you think back to 1950, we only had one oral drug, sulfonylurea. Then in 1995 — almost 50 years later — metformin was introduced (available in Europe 10 years prior to the U.S. introduction), giving us two drugs for type 2 diabetes.  Now, just about 20 years later, we have over 1,123 possible combinations of drugs for the treatment of diabetes. And according to this conference we will have a lot more in the years to come.

Novo Nordisk CMO Todd Hobbs said in an interview that they have put a lot of effort into what they hope is a blockbuster in their pipeline: semaglutide, the once-weekly GLP-1 drug that could follow in the footsteps of its blockbuster daily, Victoza. They also announced two other studies that pitted the drug against two future competitors. Semaglutide topped AstraZeneca’s weekly GLP-1, Bydureon, and Merck & Co.’s Januvia, a DPP-4 med and fellow incretin mimetic, showing “very consistent and excellent improvements” over those meds.

Also at this meeting we are getting information on at least 3 drugs that can reduce the risk of heart disease, strokes and heart attacks, which is truly exciting as most people with diabetes die from heart disease. This could change the paradigm on how we treat diabetes.

Merck & Co. and Pfizer are upbeat on their ertugliflozin cardiovascular outcomes study, as rival SGLT-2 med Jardiance continues to generate excitement for its high ratings in a heart-safety test. They are now looking to enroll 8,000 patients, to power the study to gauge ertugliflozin’s benefits as well as risks. They also added two secondary endpoints: cardiovascular death, and a composite endpoint covering CV death and hospitalization for heart failure.

Sanofi’s LixiLan is already at the FDA and even has the FDA advisory committee backing for approval. But the data keeps coming on the French drugmaker’s combo, which pairs its best-selling basal insulin, Lantus, with a new GLP-1 drug Lyxumia (lixisenatide). This medication hit its goals in two pivotal trials presented here, beating both its constituent parts in type 2 diabetes.

Eli Lilly’s GLP-1 drug Trulicity has not been just waiting around for its weekly dosing advantage, but continuing to present new data in a variety of patient groups to build a broader case. The AWARD-9 trial presented tested Trulicity alongside Sanofi’s Lantus (insulin glargine), and the combo beat Lantus alone at every measure. The new data is important “because it adds to the dataset on Trulicity and how it can be used in a clinical setting,” David Kendall, Lilly’s VP of medical affairs, stated in an interview. “Even patients who’ve progressed to insulin therapy can still benefit” from the drug.  

The Trulicity-Lantus pair delivered A1C reductions of 1.44%, compared with 0.67% for Type 2 diabetes patients taking Lantus and a placebo. Plus, more than two-thirds of patients taking both drugs hit their A1C goal of less than 7%, while 35% of patients in the Lantus arm did. Fasting blood sugar dropped more in the combo arm, and after 28 weeks of treatment, patients taking Trulicity needed fewer units of Lantus to keep their glucose levels in check. Patients in the combo group also dropped weight–1.91 kg was the median measure–while those in the Lantus arm gained 0.5 kg. On the safety side, hypoglycemia rates were similar. About one-tenth of the Trulicity patients did experience nausea and/or diarrhea, consistent with previous studies of the drug. The 300 patients enrolled in the study had been unable to hit their blood sugar targets on Lantus alone beforehand.

Then we heard more information on how Johnson & Johnson’s Invokana has helped patients lose weight — sometimes more weight than they did on another diabetes treatment. Could the drug work for weight loss in patients without diabetes? The answer was yes in a proof-of concept trial presented, which showed that combining Invokana (canagliflozin) with the older weight-loss med phentermine delivered a 7.5% loss of body weight. The 334-patient study tested the two-med combo against phentermine alone, canagliflozin alone, and a placebo. After 26 weeks, patients using the combo had lost 7.5% of their body weight, compared with 4.1% in those taking phentermine alone, 1.9% of those only taking canagliflozin, and 0.6% of placebo patients. Also, almost two-thirds of the patients taking both drugs reduced their body weight by at least 5%, compared with 17.5% of placebo patients. “The findings support the potential clinical impact that canagliflozin could have on the lives of people constantly having to manage their weight,” said Dr. James List, global head of cardiovascular and metabolism at J&J’s Janssen unit, in the interview.

 

Go to Part 2 of this article.