In The News

FDA Permits Marketing of Dermapace System to Treat Diabetic Foot Ulcers

December 28, 2017. The US Food and Drug Administration (FDA) has approved the marketing of the Dermapace System for adult patients with diabetic foot ulcers. This device is approved to treat chronic, full-thickness diabetic foot ulcers ≤16 cm2 that do not involve bone exposure. The Dermapace System mechanically stimulates foot ulcers via the use of energy pulses, similar to sound waves. In 2 double-blind, randomized, multicenter studies, 44% of patients treated with Dermapace experienced wound closure at 24 weeks, compared with 30% of patients who received sham treatment.

FDA Approves SGLT2 Inhibitor Ertugliflozin for Type 2 Diabetes

December 21, 2017. The US Food and Drug Administration (FDA) has approved the sodium-glucose cotransporter 2 (SGLT-2) inhibitor ertugliflozin for adults with type 2 diabetes (T2D). Ertugliflozin is a once-daily monotherapy available in 2 doses (5 and 15 mg); it also was approved for use in 2 fixed-dose combinations (with sitagliptin or metformin). Its approval was based on 9 phase 3 trials in approximately 12,600 adults with T2D. You can read more here.

SUSTAIN 3: Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes

December 2017. In this 56-week, phase 3, open-label, parallel-group, controlled trial, 813 patients with type 2 diabetes (T2D) were randomized 1:1 to add-on therapy with semaglutide 1.0 mg or exenatide extended-release (ER) 2.0 mg. The primary endpoint was change in A1C levels from baseline (8.3%). At study end, A1C was reduced by 1.5% with semaglutide and 0.9% with exenatide ER (P<0.0001 for noninferiority and superiority).

FDA Approves Short-Acting Insulin Admelog to Treat Diabetes

December 11, 2017. The US Food and Drug Administration (FDA) announced the approval of Admelog (insulin lispro injection), a short-acting insulin indicated to improve blood glucose control in adult and pediatric patients ≥3 years of age with type 1 diabetes and adults with type 2 diabetes. Admelog is the first short-acting insulin approved as a “follow-on” product via the FDA’s 505(b)(2) pathway. It is recommended that healthcare providers monitor potassium levels in patients taking Admelog who are at risk for hypokalemia.

FDA Approves Once-Weekly Semaglutide for T2DM

December 5, 2017. The US Food and Drug Administration (FDA) has approved the once-weekly injectable glucagon-like peptide-1 receptor agonist semaglutide (0.5 and 1.0 mg doses) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This approval was predicated on data from 8 major clinical trials, comprising more than 8,000 patients, and including a FDA-mandated cardiovascular outcomes trial.

DEVOTE: Temporal Relationships Between Severe Hypoglycemia, Cardiovascular Outcomes, and Mortality

September 15, 2017. This secondary analysis of the double-blind Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events(DEVOTE) evaluated the association between severe hypoglycemia (SH) and cardiovascular (CV) outcomes/mortality in patients randomly assigned to once-daily treatment with either insulin degludec or insulin glargine U100.

Risk Factors for Severe Hypoglycemia in Adults With Diabetes

December 1, 2017. Assessing hypoglycemia risk is essential when individualizing diabetes care. This studied aimed to evaluate risk factors for severe hypoglycemia over a median 15.2 years among 1,206 participants with diabetes, using data from the ongoing, prospective Atherosclerosis Risk in Communities (ARIC) cohort study. Mean participant age was 64 years, 46% were male, and 32% were black.

AACE and Endocrine Society Work Together to Improve Insulin Affordability and Access

November 20, 2017. The American Association of Clinical Endocrinologists and the Endocrine Society have introduced a resolution at the 2017 Interim Meeting of the American Medical Association House of Delegates to improve insulin affordability for the millions of Americans with diabetes who inject insulin daily. The resolution seeks a summit to identify solutions to dramatic insulin cost increases, reduce patient cost-sharing, curb nonmedical insulin switching, facilitate greater insulin pricing transparency, and integrate drug formularies into electronic medical records.

Canagliflozin Reduces Cardiovascular Events in Patients With Type 2 Diabetes Regardless of Cardiovascular Disease History

November 13, 2017. A prespecified data analysis from the Canagliflozin Cardiovascular Assessment Study (CANVAS) found that canagliflozin, a sodium glucose cotransporter 2 (SGLT-2) inhibitor, reduced cardiovascular (CV) events in patients with type 2 diabetes and with and without a history of CV disease (the secondary prevention cohort, n=6,656, and primary prevention cohort, n=3,486, respectively). The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

National Clinical Care Commission Act Becomes Public Law

November 2, 2017. President Trump has signed the National Clinical Care Commission Act (S. 920) to establish a public/private commission of experts and patient advocacy representatives to collectively assess federal government diabetes programs, identify inefficiencies and gaps, and provide recommendations to the US Department of Health and Human Services and Congress to improve diabetes care. Congratulations to all AACE advocates, the broad diabetes community, and industry partners who worked to support this legislation.