Diabetes News
Ursula Biba, Rhea W. Teng, Martin J. Kurian, and Kelly L. Close are of Close Concerns (http://www.closeconcerns.com), a healthcare information company focused exclusively on diabetes and obesity care. Close Concerns publishes Closer Look, a periodical that brings together news and insights in these areas. Each month, the Journal of Diabetes includes this News feature, in which Biba, Teng, Kurian, and Close review the latest developments relevant to researchers and clinicians.
1 AMERICAN ASSOCIATION FOR DIABETES EDUCATORS (AADE) 2019
AADE took place in Houston, Texas, August 9-12. Eli Lilly's (Indianapolis, Indiana) US medical lead for glucagon, Julie Settles, gave one of the most distinctive talks of the conference. She presented compelling data that showed the vastly improved ease of use and overall satisfaction of nasal glucagon vs its injectable counterpart. The study design mimicked a real-world situation in which emergency glucagon would be required, as it had trained and untrained caregivers give a high-fidelity manikin glucagon. Of the trained users (n = 32), 90.3% of nasal glucagon users were able to administer medication successfully, whereas only 15.6% of injected glucagon users were able to do so.1 In a follow-up study, even 90% of untrained users (n = 33) were able to successfully administer nasal glucagon, whereas none were able to use the injected glucagon successfully.1 Participants favored nasal glucagon and found it easier to prepare and use. Also related to nasal glucagon, a poster presented at the meeting detailed results from a cost-offset model of nasal glucagon vs injectable glucagon, showing considerable savings per severe hypoglycemic event with Baqsimi. Those on commercial insurance saved $929, those on Medicare Advantage saved $502, and those on Managed Medicaid saved $335. Savings were driven by increased likelihood of successful administration with nasal administration compared to injection.2 The model used in this study cited the aforementioned study of nasal glucagon, which found 90% success rates for nasal glucagon administration compared to 15% for injectable glucagon.2
2 HEART IN DIABETES 2019
Heart in Diabetes took place in Philadelphia, Pennsylvania from July 12-14. Dr Silvio Inzucchi (Yale University, New Haven, CT) assessed where the American Diabetes Association/European Association for the Study of Diabetes Consensus Algorithm on type 2 diabetes was “on target” and pointed out specific instances where it may have “missed the mark.” He lauded the algorithm for placing cardioprotective agents, like sodium-glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) agonists, at the top of the treatment algorithm after metformin for those with established atherosclerotic cardiovascular disease (ASCVD) or chronic kidney disease (CKD). He also stated that the algorithm's recommendation of an SGLT-2 inhibitor for those with established CKD was very forward-thinking given that no formal renal protection studies had yet released results when the algorithm was created. The algorithm “missed the mark” in his opinion by prematurely including heart failure data in prescribing decisions, recommending GLP-1 agonists after SGLT-2 inhibitors in patients with heart failure although there is a relative paucity of evidence for this recommendation and by making thiazolidinediones (TZDs) a relative afterthought.
Dr Elizabeth Selvin (Johns Hopkins University, Baltimore, MD) reviewed the evidence linking hypoglycemia to CVD and neurological disease in people with type 2 diabetes, focusing on the Atherosclerosis Risk in Communities Study (ARIC) study. Results showed significant associations between severe hypoglycemia and coronary heart disease, all-cause mortality, and cardiovascular mortality when adjusted for myriad factors.3 Nonsignificant trends toward association between severe hypoglycemia and heart failure, atrial fibrillation, and peripheral artery disease were also found.3 Dr Selvin noted that cause and effect cannot be isolated in these studies, which are not designed to investigate hypoglycemia specifically. On neurology, a later analysis of ARIC data found a nonsignificant association in older adults between severe hypoglycemia and mild cognitive impairment (adjusted OR = 1.51, 95% CI: 0.82-2-.76), and a significant association between severe hypoglycemia and dementia (adjusted OR = 2.35, 95% CI: 1.05-5.35).
COMPANY UPDATES | |
17 July 2019 | Adocia (Lyon, France) announced pipeline progression for their pramlintide insulin candidate, ADO09, with results expected in late 2019. |
18 July 2019 | Novartis (Basel, Switzerland) initiated a phase 3 trial (TALON) for their antivascular endothelial growth factor therapy brolucizumab. The trial is a head-to-head of brolucizumab vs aflibercept for diabetic macular edema. |
22 July 2019 | Sernova (London, Ontario, Canada) announced positive preliminary results in safety, tolerability, and efficacy for their Cell Pouch beta cell encapsulation system in type 1 diabetes. |
23 July 2019 | The Food and Drug Administration (FDA) approved Baxter's (Deerfield, IL) Myxredlin, the first premixed and ready-to-use insulin for IV infusion in hospital and acute care settings. |
23 July 2019 | FDA tentatively approved Sandoz's (Holzkirchen, Germany) Abbreviated New Drug Application (ANDA) for a potential generic of AstraZeneca's SGLT-2 inhibitor Farxiga (dapagliflozin). |
24 July 2019 | Eli Lilly's (Indianapolis, Indiana) nasal glucagon, Baqsimi, gained FDA approval, making it the first-ever severe hypoglycemia emergency treatment that does not require an injection. |
24 July 2019 | Alembic Pharmaceuticals (Vadodara, India) received tentative FDA approval for its ANDA for a generic version of AstraZeneca's SGLT-2 inhibitor Farxiga. |
25 July 2019 | AstraZeneca (Cambridge, UK; AZ) announced the addition of two more heart failure studies for Farxiga: DETERMINE-Reduced and DETERMINE-Preserved for heart failure with reduced and preserved ejection fraction, respectively. AZ also added a phase 1 NASH candidate (AZD2693) and a phase 2 painful diabetes neuropathy candidate (a tumor necrosis and nerve growth factor) to its pipeline. |
26 July 2019 | Sanofi (Paris, France) terminated their collaboration with Lexicon (The Woodlands, Texas) to develop, manufacture, and commercialize Zynquista (sotagliflozin). |
29 July 2019: | Pfizer (New York, NY) advanced its ACC and DGAT2 inhibitor combination (PF-07055341) for NASH treatment from phase 1 to phase 2. |
30 July 2019 | Eli Lilly's Jardiance (empagliflozin) was submitted to the FDA for type 1 diabetes. The company's oral GLP-1 candidate (OWL833) has also moved into phase 1. |
31 July 2019 | vTv (High Point, NC) began screening for a phase 2/3 trial of azeliragon in mild Alzheimer's disease and type 2 diabetes. |
5 August 2019 | AstraZeneca's Forxiga (dapagliflozin) received a formal approval from the European Commission to include positive cardiovascular and renal data from the DECLARE trial on its label.4 |
6 August 2019 | FDA granted Breakthrough Therapy Designation to Provention Bio's (Oldwick, NJ) teplizumab for the prevention or delay of clinical type 1 diabetes in at-risk individuals. |
6 August 2019 | Novo Nordisk (Bagsværd, Denmark) acquired a factory in North Carolina for the production of oral semaglutide. |
9 August 2019 | Novo Nordisk (Bagsværd, Denmark) initiated four new outcome trials for semaglutide: FOCUS for retinopathy outcomes, SUSTAIN FORTE for high doses, FLOW for chronic kidney disease, and SOUL CVOT for oral semaglutide. The company also announced positive topline results from the phase 2 trial investigating combination anti-IL-21 and liraglutide in people with type 1 diabetes. The study found statistically significant improvements in beta cell function with the combination therapy vs placebo. Two phase 1 candidates, next-generation basal insulin FSI965 and obesity therapy LA-GDF15 were also added to the company's pipeline. |
13 August 2019 | A prefilled syringe for Regeneron's (Tarrytown, NY) Eylea (injectable aflibercept) was approved by FDA. |