In The News

FDA Approves a New, Faster-Acting Mealtime Insulin for Adults With Type 1 and Type 2 Diabetes

October 3, 2017. The US Food and Drug Administration (FDA) has approved a new, faster-acting injected mealtime insulin called Fiasp ("fast-acting insulin aspart"). Fiasp is similar to the mealtime insulin NovoLog but with a quicker onset and offset; Fiasp can be used as late as 20 minutes after starting a meal (although before-meal administration is preferable), and the more rapid offset reduces the risk of post-meal hypoglycemia. Fiasp will be offered at the same price as NovoLog.

FDA Approves the FreeStyle Libre Flash Glucose Monitoring System for Adults With Diabetes

September 27, 2017. The US Food and Drug Administration (FDA) has approved the first continuous glucose monitoring system that does not require a "fingerstick" blood sample. The FreeStyle Libre Flash Glucose Monitoring System uses a small sensor wire inserted below the skin's surface. By waving a mobile reader above the sensor, a user can determine if glucose levels are too high or low, as well as see changes in glucose levels that can inform diabetes treatment decisions. The system can be worn for up to 10 days after a 12-hour start-up period.

Evolocumab Is Effective and Safe for People With and Without Diabetes

September 15, 2017. Evolocumab is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor that reduced cardiovascular (CV) events and low-density lipoprotein cholesterol over a median of 2.2 years in the randomized FOURIER trial (N=27,564). This prespecified post-hoc analysis investigated the efficacy and safety of evolocumab vs placebo among patients with (n=11,031) and without diabetes (n=16,533) at baseline. The impact of evolocumab on the risk of developing diabetes also was investigated.

Empagliflozin Improves Clinical Outcomes and Reduces Mortality in Patients With Diabetes, Cardiovascular Disease, and Chronic Kidney Disease

September 13, 2017. The EMPA-REG OUTCOME trial investigated the impact of empagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, on 7,020 patients with type 2 diabetes (T2D) and cardiovascular (CV) disease. This analysis of a subset of patients with T2D, CV disease, and chronic kidney disease at baseline found that empagliflozin is not only safe, but improves clinical outcomes and reduces mortality when added to standard of care treatment.

DEPICT-1 Trial: Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes

September 14, 2017. This 24-week double-blind, multicenter, randomized controlled trial evaluated the safety and efficacy of the sodium-glucose cotransporter-2 inhibitor dapagliflozin in patients with type 1 diabetes (T1D) not adequately controlled on insulin therapy. Patients were randomly assigned to receive dapagliflozin 5 mg or 10 mg, or placebo. The primary endpoint was A1C reduction from baseline. At 24 weeks, the mean A1C difference from baseline vs placebo was -0.42% and -0.45% for dapagliflozin 5 and 10 mg, respectively (P<0.0001 for both).

DURATION-8 Trial: Efficacy and Safety of Once-Weekly Exenatide Plus Once-Daily Dapagliflozin vs Exenatide or Dapagliflozin Alone

September 13, 2017. This 28-week double-blind, multicenter, randomized controlled trial evaluated the efficacy of once-weekly exenatide 2 mg (EXE) with or without dapagliflozin 10 mg (DAPA) in patients with type 2 diabetes inadequately controlled on metformin alone. Participants were randomized to receive EXE + DAPA, EXE + oral placebo, or DAPA + injected placebo; the study also included a 24-week extension phase.

Risk of Lower Extremity Amputations in Patients With Type 2 Diabetes Mellitus Using SGLT2 Inhibitors

September 12, 2017. This retrospective, real-world study evaluated the risk of below-knee lower extremity (BKLE) amputation among patients with type 2 diabetes taking any sodium glucose co-transporter 2 (SGLT-2) inhibitor (118,018 patients total), including 73,024 patients taking canagliflozin. Researchers compared the incidence of BKLE among these patients compared with 226,623 patients taking antihyperglycemic agents (AHAs) other than SGLT-2 inhibitors. All patients included in the study were using SGLT-2 inhibitors or other AHAs for the first time.

FDA Grants Tentative Approval for Admelog (Insulin Lispro Injection)

September 1, 2017. The U.S. Food and Drug Administration (FDA) has granted tentative approval to Sanofi for a rapid-acting human insulin analog called Admelog (insulin lispro injection) 100 units/mL, indicated to improve glycemic control in adults and children with diabetes. Tentative approval was granted because Admelog is similar to FDA-approved insulin lispro injection in its physiochemical, nonclinical, and clinical characteristics.

Acute Kidney Injury in Patients Using SGLT2 Inhibitors: What's the Risk?

August 21, 2017. Recently, the U.S. Food and Drug Administration (FDA) issued alerts for 2 sodium-glucose cotransporter-2 (SGLT-2) inhibitors, canagliflozin and dapagliflozin, regarding an increased risk for acute kidney injury (AKI). In response, researchers evaluated data from 2 large health care utilization cohorts to assess the risk of AKI among patients with type 2 diabetes who use SGLT-2 inhibitors in a real-world setting. Researchers compared the incidence of AKI events over a median of 14 months between SGLT-2 inhibitor users and nonusers.

Comparing the Efficacy and Safety of SGLT2 Inhibitors vs DPP4 Inhibitors as Monotherapy or Add-on to Metformin: A Systematic Review and Meta-Analysis

August 10, 2017. Sodium-glucose cotransporter-2 (SGLT-2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors are both indicated as monotherapy or add-on to metformin for patients with type 2 diabetes (T2D). This systematic review and meta-analysis of 25 randomized controlled trials (N=14,619) compared the efficacy and safety of SGLT-2 vs DPP-4 inhibitors in this therapeutic context.

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