In The News

The Impact of Severe Hypoglycemia on Economic and Patient-Reported Outcomes

January 5, 2018. This observational, cross-sectional study found that reducing the frequency and severity of hypoglycemia could improve health-related quality of life (HRQoL) and reduce health care utilization and costs. Using data from the US National Health and Wellness Survey, the impact of hypoglycemia on health care resource utilization, HRQoL, work productivity and activity impairment, and estimated direct and indirect costs, were analyzed. Surveyed adults had type 2 diabetes and were using a basal insulin with oral antidiabetic drugs or rapid-acting/premixed insulins.

Updated Warning: FDA Warns of Diabetic Ketoacidosis and Serious Urinary Tract Infections with SGLT-2 Inhibitor Use

January 19, 2018. The US Food and Drug Administration (FDA) has identified further evidence supporting its May 2015 decision to revise the labeling for sodium-glucose cotransporter-2 (SLGT-2) inhibitors in patients with type 2 diabetes. Based on data submitted to the FDA’s Adverse Event Reporting System database, this update warns that use of these drugs may result in life-threatening diabetic ketoacidosis (DKA) and serious urinary tract infections (UTIs). In all identified cases (73 DKA and 19 UTIs), patients required emergency treatment or hospitalization.

Metformin Use Safe in Moderate-to-Severe Chronic Kidney Disease and Type 2 Diabetes

January 5, 2018. Three studies were conducted to establish a safe, effective metformin dose for patients with type 2 diabetes (T2D) and moderate (stages 3A/3B) to severe (stage 4) chronic kidney disease (CKD). First, a dose-finding study evaluated blood metformin concentrations over 1 week in response to dose increases. Appropriate daily dosages were found to be: 1,500 mg in CKD3A; 1,000 mg in CKD3B; and 500 mg in CKD4. Next, a treatment study monitored patient blood metformin, lactate, and A1C levels to validate the previously identified optimal metformin dosage for each CKD stage.

The Effect of Triple Therapy With Exenatide, Dapagliflozin, and Metformin on Cardiovascular Risk Factors in Patients With Type 2 Diabetes

January 5, 2018. DURATION-8 was a 28-week, phase 3, randomized controlled trial evaluating the efficacy and safety of exenatide once weekly (QW) + dapagliflozin vs either drug alone, all added to metformin monotherapy in 695 patients with type 2 diabetes. This post-hoc analysis grouped patients according to their baseline body weight, systolic blood pressure (SBP), and triglyceride levels and then assessed the impact of exenatide QW + dapagliflozin, exenatide QW, or dapagliflozin on these risk factors.

Incretin-Based Therapies Do Not Increase Pancreatic Cancer Risk Among Patients With Type 2 Diabetes

January 3, 2018. This meta-analysis of 33 randomized controlled trials of ≥52 weeks’ duration in 79,971 individuals with type 2 diabetes evaluated the risk of pancreatic cancer in patients using incretin-based therapies vs placebo or other antidiabetic drugs. A total of 87 pancreatic cancer events were observed.

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.

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