In The News

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.

Minimizing Glycemic Fluctuations in Patients With Type 2 Diabetes: Approaches and Importance

August 3, 2017. This review article examines the importance of and strategies for minimizing glycemic fluctuations in patients with type 2 diabetes (T2D). The authors note that measurements like A1C, fructosamine, and glycated albumin reflect a long-term average of plasma glucose and do not accurately measure short-term glycemic oscillations. Continuous glucose monitoring (CGM) more accurately monitors real-time glucose fluctuations.

FDA Grants Cardiovascular Indication for Liraglutide

August 25, 2017. The US Food and Drug Administration has granted a new indication for the diabetes drug liraglutide: to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease. This decision was based on data from the landmark LEADER trial, which found that adding liraglutide to standard of care reduced the risk of a composite CV endpoint by 13% vs placebo, representing a 1.9% absolute risk reduction (ARR). The LEADER trial also found a 22% reduction in CV death with liraglutide vs placebo (ARR 1.3%).

Sodium-Glucose Cotransporter-2 Inhibition Improves Incretin Sensitivity of Pancreatic β-cells in Patients With Type 2 Diabetes

August 8, 2017. This study evaluated whether the sodium-glucose cotransporter-2 (SGLT-2) dapagliflozin improved beta-cell incretin sensitivity by reducing glucotoxicity. In this 3-hour hyperglycemic clamp study, synthetic glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) were infused to 19 subjects with type 2 diabetes (T2D) and 10 with normal glucose tolerance (NGT). Subjects with T2D were evaluated twice—before and 8 weeks after treatment with dapagliflozin; subjects with NGT were evaluated once.

Cardiovascular Mortality and Morbidity in Patients With Type 2 Diabetes Following Initiation of Sodium-Glucose Cotransporter-2 Inhibitors Versus Other Glucose-Lowering Drugs (CVD-REAL Nordic): A Multinational Observational Analysis

August 3, 2017. This real-world, clinical practice-based study was designed to compare cardiovascular (CV) mortality and morbidity in new users of sodium-glucose cotransporter-2 (SGLT-2) inhibitors compared with new users of other glucose-lowering drugs. The CVD-REAL Nordic multinational observational analysis evaluated data for all patients who filled a prescription for glucose-lowering drugs between 2012 and 2015 in Denmark, Norway, and Sweden.

Results of Real-World Study Show Dapagliflozin Decreases Cardiovascular Events and All-Cause Mortality Risk Compared to DPP-4 inhibitors in Patients With Type 2 Diabetes

August 3, 2017. The results of Dapagliflozin Compared to DPP-4 inhibitors is Associated with Lower Risk of Cardiovascular Events and All-cause Mortality in Type 2 Diabetes Patients (CVD-REAL Nordic) show that, in a real-world setting, patients who use dapagliflozin experience lower risk of hospital events for heart failure (HHF), major adverse cardiac events (MACE), and all-cause mortality compared with patients who receive dipeptidyl peptidase-4 inhibitors (DPP-4i).

Updated Self-Management of Diabetes Recommendations From the American Diabetes Association and the American Association of Diabetes Educators Integrate Education With Support

July 28, 2017. The American Diabetes Association (ADA) and American Association of Diabetes Educators (AADE) have updated their diabetes self-management guidelines to integrate the education and support aspects of care for patients with diabetes. Education and support were presented as 2 separate topics in previous ADA/AADE National Standards for Diabetes Self-Management Education and Support, published in 2014. These topics were combined to reflect the importance of ongoing support for patients with diabetes.

SGLT2 Inhibitors and Diabetic Ketoacidosis: Data From the FDA Adverse Event Reporting System

Regulatory agencies have reported a potential link between sodium-glucose cotransporter-2 (SGLT-2) inhibitor use and diabetic ketoacidosis (DKA). To examine this, investigators conducted a detailed analysis of DKA events observed in patients using SGLT-2 inhibitors, as reported to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). FAERS data covered the first quarter of 2014 through the third quarter of 2016; data were evaluated using proportional reporting ratios (PRRs) and safety signals.

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