2018 Biomedtracker / Datamonitor Healthcare / Meddevicetracker Post-ADA Report

The American Diabetes Association (ADA) 78th Scientific Sessions was held in Orlando, FL from 22–26 June 2018. While there were no major new ground-breaking results presented, the highlight of this year's conference was further details from oral semaglutide's (NVO) Phase III program, since the GLP-1 agonist appears more efficacious than other oral options and even than Novo's own injectable Victoza. While Novo had additional data from its trial of recently approved injectable semaglutide (Ozempic) showing advantages over Lilly's Trulicity, the latter had data from a higher-dose study.

A Januvia (MRK) study raised questions whether the DPP-IV inhibitor was more effective on glycemic control than SGLT-2 inhibitors in stage 2 renal impairment, though a KOL was skeptical. The results were particularly notable as soon after the conference, JNJ announced its SGLT-2 inhibitor Invokana met an interim analysis in its Phase III DN trial CREDENCE, though without details.

Meanwhile, long-acting insulins Toujeo (SNY) and Tresiba (NVO) continued to battle with competing data from a comparative trial and real- world studies.

A major highlight outside of study results was the ADA/EASD's release of a draft consensus treatment algorithm. While the algorithm retained metformin as the first-line choice, it subsequently focused on whether patients had atherosclerotic cardiovascular disease/heart failure, highlighting the GLP-1 agonists and SGLT-2 inhibitors with proven CV benefits. Other steps focused on whether there was a need for hypoglycemia minimization and weight loss.

On the device front, there was interesting data on Insulet's Omnipod Horizon hybrid closed-loop system, a three-way comparison of CGM devices (Senseonics' Eversense, Dexcom G5, and Abbott's Freestyle Libre Pro), and Medtronic's new Sugar.IQ app for its Guardian Connect CGM system.

This report also has information and commentary on:

GLP-1 Agonists

• AZN's GLP-1/glucagon receptor dual agonist MEDI0382
• New data on Victoza in type 1

SGLT Inhibitors

• Zynquista (SNY, LXRX) and Farxiga (AZN, BMY, Ono) updated and new data in type 1 diabetes
• SGLT-2/GLP-1 agonist combinations
• Farxiga in diabetics with heart failure
• Invokana (JNJ, Daiichi Sankyo, Mitsubishi Tanabe) amputation risk from an observational study, CV effects by renal impairment status from CANVAS, and effects on diastolic dysfunction

SGLT-2/DPP-IV Inhibitor Fixed-Dose Combination

• AZN’s Qtern versus insulin glargine

Other Mechanisms

• Updated Phase II data from second-generation MetAP2 inhibitor ZGN-1061 (ZFGN)

Devices

• Several closed loop systems, including DBLG1 (Diabeloop, Cellnovo) and investigator-initiated trials on inpatient, non-critical-care use and inclusion of pramlintide
• Reapplix's LeucoPatch (3CPatch in the US) versus standard-of-care in hard-to-heal diabetic foot ulcers

Like our report? Have any questions or feedback? Please let us know at [email protected].