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Year In Review: Diabetes

Discussion in 'Endocrinology' started by Mahmoud Abudeif, Nov 26, 2019.

  1. Mahmoud Abudeif

    Mahmoud Abudeif Golden Member

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    Throughout this year, diabetes medicine saw a flurry of new approved agents, along with expanded indications to existing therapies.

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    New Approvals, Indications, and Wins

    Two of the newest classes of antidiabetic agents -- sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) -- continued to grow in popularity this year.

    This was marked by the first approval of an oral formulation of a GLP-1 RA -- Novo Nordisk's semaglutide (Rybelsus) for type 2 diabetes -- based upon the findings of the PIONEER trials. Agents in this class are typically administered as once-weekly injectables, with semaglutide having been previously approved in its injectable form (Ozempic) back in 2017.

    Another GLP-1 RA -- Novo Nordisk's liraglutide (Victoza) -- underwent a label expansion to include an indication for kids ages 10 and older with type 2 diabetes. This new indication makes liraglutide the first non-insulin treatment for pediatric type 2 diabetes since metformin.

    Another big win for these newer antidiabetic agents came in the form of label expansions to Janssen's SGLT2 inhibitor canagliflozin (Invokana) in type 2 diabetes. New indications for the drug now include cardiovascular and renal preventions for adults with diabetic kidney disease: the prevention of end-stage kidney disease, worsening renal impairment, cardiovascular death, hospitalization for heart failure, and diabetic nephropathy with albuminuria. The once-daily oral medication already went through its first label expansion last year, when it gained indications for the prevention of myocardial infarction, stroke, and death among patients with type 2 diabetes and established cardiovascular disease.

    Similarly, SGLT2 inhibitors that contain dapagliflozin (Farxiga, Xigduo) also gained approval for new indications in 2019, based on findings of the DERIVE study, and are now okayed for use in patients with type 2 diabetes and chronic kidney disease with an estimated glomerular filtration rate of 45-59 mL/min/1.73 m2.

    New type 2 diabetes agents weren't the only new approvals this year. Over the summer, the first-ever glucagon rescue treatment for severe hypoglycemia that doesn't require an injection was approved. Eli Lilly's Baqsimi instead is delivered via an intranasal powder through a single-use dispenser, available for patients ages 4 years and up with type 1 or type 2 diabetes.

    Another rescue glucagon for severe hypoglycemic events was also approved. Xeris Pharmaceuticals's Gvoke, a ready-to-use injectable comprised of room-temperature stable liquid glucagon, is indicated for patients with diabetes ages 2 years and up.

    Advancements in diabetes technology also took a big step forward in 2019. In February, the first interoperable insulin pump was authorized for marketing by the FDA: the Tandem Diabetes Care t:Slim X2 insulin pump. The "interoperable" technology of the pump can be custom-tailored to be used with other components of a patient's diabetes management system.

    And in October, the latest generation of Dexcom's continuous glucose monitor (CGM) -- the G6 Pro -- was cleared by the FDA for use in patients with diabetes ages 2 years and older. Some new features of this CGM include a blinded mode, which lets the real-time glucose data go right to the healthcare professional without the patient's knowledge, as well as an unblinded mode that allows the patient to see the glucose readings.

    Rapid-acting insulin aspart (Fiasp) was also approved by the FDA for use in insulin pumps. Indicated for use in adults with either type 1 or type 2 diabetes, the label for Novo Nordisk's insulin aspart now includes multiple dosing options for continuous subcutaneous insulin infusion in pumps.

    Flops in Type 1 Diabetes

    Not everything came up roses for diabetes this year, as there were some rejections of investigational therapies. One of the biggest disappointments came when an FDA advisory panel declined to recommend the SGLT2 inhibitor empagliflozin (Jardiance) for approval in type 1 diabetes. Already approved for type 2 diabetes at 10 mg and 25 mg doses, Boehringer Ingelheim's once-daily oral treatment was revamped into a lower-dose, 2.5 mg formula with a proposed new trade name exclusive to the type 1 diabetes community. However, only 2 members of the panel voted to recommend approval, with 14 voting against -- the advisory committee was hung up on the potential risk for diabetic ketoacidosis and lack of long-term follow-up data from the EASE program. Although the FDA hasn't made its final approval decision on the drug, it often follows the recommendations of its advisory committees.

    Empagliflozin wasn't the only new drug seeking approval for type 1 diabetes that faced turmoil this year. Sanofi's dual SGLT1/2 inhibitor sotagliflozin (Zynquista) was formally turned down for approval by the FDA, following a split advisory committee vote at the start of the year. Seeking approval as an add-on to insulin for patients with type 1 diabetes, the ever-present worry about the risk for diabetic ketoacidosis played a large part in certain voting members giving this drug a "no."

    In a similar vein, the SGLT2 inhibitor dapagliflozin (Farxiga) was also turned down after AstraZeneca sought a label expansion with the DEPICT program data to include an indication as an adjunct to insulin for type 1 diabetes.

    Research Advancements in Type 1

    One of the biggest headlines in type 1 diabetes research was the promise of a possible preventative in high-risk individuals. Specifically, a prophylactic 14-day course of treatment with the anti-CD3 antibody teplizumab in individuals with first-degree relatives diagnosed with type 1 diabetes had a significantly reduced risk of progressing to the disorder themselves. The TrialNet Study reported at this year's American Diabetes Association (ADA) meeting that only 43% of those who received teplizumab were diagnosed with type 1 diabetes 5 years after randomization compared with 72% of those who received placebo.

    Another study this year found that allogeneic islet transplantation helped people with type 1 diabetes achieve long-term glycemic control. Although the study included only 28 patients, 28% of the group were free of insulin and maintained normoglycemia with an HbA1c of 6.5% or less 10 years after transplantation. And almost 40% were able to ditch insulin 5 years after transplantation.

    Finally, an Australian study reported a 14% decline in type 1 diabetes incidence in infants and young children after the oral rotavirus vaccine was added to the list of vaccines as part of the Australian National Immunisation Program.

    New Age of Technology

    One of the biggest themes in diabetes medicine this year was the push beyond therapeutics and into technology. Most of these technological advancements came with systems, such as CGMs, insulin pumps, and closed-loop systems, which helped to make the daily struggle of diabetes more manageable for patients.

    This kicked off with the ADA's release of a new report to offer guidance on diabetes technology specifically tailored for primary care doctors.

    "Diabetes technology is changing at a very rapid pace," the lead author of the guidance, James Chamberlain, MD, of St. Mark's Hospital and St. Mark's Diabetes Center in Salt Lake City, told MedPage Today earlier this year. "Patients are asking their providers about insulin delivery systems, continuous glucose monitoring, insulin pumps, and hybrid closed-loop pump products, and we believe primary care providers must have at least a basic understanding of these technologies."

    The guidelines walks primary care docs through the ins and outs of blood glucose monitoring for patients with type 1 or type 2 diabetes, performed through the traditional self-monitoring method or with a CGM. They also gave a top-line grade "A" recommendation to automated insulin delivery for any patient ages 7 years and up with type 1 diabetes, tied together by an insulin pump, CGM, and algorithm for insulin delivery.

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