The 79th Scientific Sessions of the American Diabetes Association (ADA) were many meetings in one—the presentations on basic science, clinical trials, diet and nutrition, diabetes technology, and policy and advocacy bring more than 14,000 participants together. This year’s sessions
, held June 7-11, 2019, in San Francisco, California, had something for everyone. Here are 5 takeaways from ADA.
1. Renal outcomes for type 2 diabetes therapies are big news
Follow-up results from CREDENCE
, the first dedicated renal outcomes trial for canagliflozin, and analyses of data from DECLARE
and EMPA-REG OUTCOME, the earlier cardiovascular outcomes trials for dapagliflozin and empagliflozin, point to the ability of sodium glucose cotransporter 2 (SGLT2) inhibitors to keep people with type 2 diabetes (T2D) from progression to chronic kidney disease and ultimately ending up on dialysis. The connections
among diabetes, cardiovascular disease, and renal decline were a theme throughout the ADA Sessions—look for renal indications to be the next big area of competition among T2D drugs, and SGLT2 inhibitors in particular. Other dedicated renal outcomes trials, DAPA-CKD and EMPA-KIDNEY, are under way.
2. Oral semaglutide posts some big wins, along with a mixed result
Many attendees were waiting to see results for Novo Nordisk’s investigational drug oral semaglutide, which already has an application pending at FDA under priority review, with a decision due in September. The first glucagon-like peptide 1 (GLP-1) receptor agonist to come in a pill could be a game-changer if it brings the superior glycemic control and weight loss benefits of the GLP-1 class to patients who have been fearful of using injectable drugs. Early in the ADA Sessions, results
from PIONEER 2 and PIONEER 4 showed oral semaglutide offered better glycemic control than empagliflozin and more weight loss than liraglutide. But all eyes were on PIONEER 6
, the cardiovascular outcomes trial. Results showed that the drug is safe and it did reduce deaths, but the short trial didn’t quite meet the standard of superiority needed to demonstrate a clear benefit. A commentator at the presentation pointedly asked why not. It’s expected that Novo Nordisk will pool data from PIONEER 6 and the CV outcomes trial for injectable semaglutide, SUSTAIN 6, to ask FDA for CV indications for both formulations.
3. ADA presents time-in-range results for CGM users
The consensus report
from a panel of international experts who met in February is newsworthy for many reasons—it represents the first evidence-based guidelines for time-in-range with continuous glucose monitoring (CGM), which is becoming as important as glycated hemoglobin (A1C) as an assessment of overall health and a predictor of future complications, Second, it shows how far CGM has come as a disease management tool and why it is poised to become mainstream for those with T2D. Third, while the guidelines were presented at ADA, they were endorsed by every major clinical, education, and advocacy group in the diabetes community. In general, the consensus is that most adults should keep their blood glucose in the range of 70 to 180 mg/dL for 70% of the day, or just under 17 hours.
4. Tech, tech, and more tech
Cruising the exhibit floor is always a highlight of the ADA Sessions, because this is where one gets to see and touch the latest in rapidly advancing diabetes technology. The ADA Sessions are always the time of year when everyone from major CGM and insulin pump makers to upstarts announce partnerships or product rollouts, and 2019 was no exception. This year, the DiabetesMine
D-Data ExChange kicked off the tech conversation June 7 on the first day of the sessions. Tidepool
, which is developing Tidepool Loop, announced major agreements with the CGM maker Dexcom and diabetes technology giant Medtronic. On the ADA exhibit floor, Glooko used a high-profile spot to highlight its brand-new agreement
with Companion Medical, the makers of InPen. The demo booth for Eversense’s implantable CGM was a popular stop, as were updates
about the study Senseonics has under way to extend approval of its sensor from the current 90 days to 180 days.
5. Real-world data get more attention
FDA says it plans to pay more attention to real-world data, which are making more headlines at conferences, too. Data from claims have always been important to payers, who want to know how drugs and products perform in patients with comorbidities or other challenges that would keep them out of clinical trials. Abbott’s FreeStyle Libre made headlines
early in the meeting with news that its popular flash glucose monitoring system brought A1C down by 0.9% for people with T2D after just 3 months of use. And the first results from an ongoing real-world study, EMPRISE
, were presented in an oral session. This study comparing patients taking empagliflozin with those taking dipeptidyl peptidase 4 inhibitors found that patients taking empagliflozin have fewer cardiovascular events, but that overall cost of care for the 2 groups is about the same.