In The News

FDA Panel Supports Dexcom Continuous Glucose Monitoring for Insulin Dosing in Patients With Diabetes

July 22, 2016. A US Food and Drug Administration (FDA) advisory panel has voted in favor of allowing the Dexcom G5 Mobile continuous glucose monitoring (CGM) system to be used as a replacement for fingerstick glucose monitoring in patients with diabetes. Currently, this device is indicated for adjunctive use along with self-monitoring of blood glucose to provide trend information and alert patients to high and low blood glucose values.

Coprogression of Cardiovascular Risk Factors in Type 1 Diabetes During 30 Years of Follow-up in the DCCT/EDIC Study

July 2016. The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study demonstrated the beneficial effect of intensive therapy on cardiovascular outcomes, while identifying hyperglycemia as a dominant risk factor for patients with type 1 diabetes (T1D). This analysis evaluated the extent to which glycemic exposure influenced long-term changes in established risk factors for cardiovascular disease (CVD) among patients with T1D. Of the surviving DCCT cohort, 96% were enrolled for an additional 20-year observational study.

FDA Approves a Dedicated Syringe to Be Used With Humulin R U-500 Insulin

July 8, 2016. The US Food and Drug Administration (FDA) has approved a dedicated syringe for the administration of Humulin R U-500 insulin. This is now the only device approved for use with the U-500 insulin vial. Since conversions are no longer needed with this new device, the Humulin R U-500 insulin vial label will be updated to remove the dose conversion information for U-100 and tuberculin syringes. Approved syringes for use with Humulin R U-500 insulin vials will only be available with a prescription and should be co-prescribed with U-500 insulin.

Do Patient Characteristics Impact Decisions by Clinicians on Hemoglobin A1C Targets?

June 20, 2016. This retrospective study was conducted to determine whether physicians consider individualized risks and the benefits of tight glycemic control when setting A1C targets. Investigators evaluated National Health and Nutrition Examination Survey (NHANES) data for individuals with self-reported diabetes over an 8-year period between 2005 and 2014.

Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Patients With Type 2 Diabetes (LIRA-SWITCH)

July 2016. This randomized, double-blind, double-dummy, active-controlled 26-week trial was conducted at 86 sites worldwide to confirm the superiority of switching from sitagliptin to liraglutide on glycemic control. Participating patients (N=407) had type 2 diabetes (T2D) managed with metformin and sitagliptin. The primary endpoint was changes in A1C levels, with a secondary endpoint of change in body weight.

Cardiovascular Safety of Empagliflozin In Patients With Type 2 Diabetes: A Meta-analysis

July 2016. This meta-analysis of data from 8 randomized placebo-controlled trials was conducted to evaluate the efficacy and safety of empagliflozin 10 mg and 25 mg once daily in patients with type 2 diabetes and at low/medium and high cardiovascular (CV) risk. The primary endpoint was a 4-point major adverse CV events (MACE) composite of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, and hospitalization for unstable angina. The secondary endpoint was a 3-point MACE composite of CV death, non-fatal MI, and non-fatal stroke.

Persistent Effects of Intensive Glycemic Control on Retinopathy in Type 2 Diabetes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Follow-On Study

July 2016. This study evaluated whether the beneficial effects of intensive glycemic control and fenofibrate treatment to reduce retinopathy progression in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study persisted in the 4 years beyond the initial study period. Progression was defined as ≥3 steps in the Early Treatment Diabetic Retinopathy Study Scale. At follow-up, all patients had similar A1C levels.

Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes

June 14, 2016. This study evaluated a prespecified secondary objective of the EMPA-REG OUTCOME study: long-term renal outcomes associated with the use of the sodium-glucose cotransporter-2 inhibitor empagliflozin in patients with type 2 diabetes at high risk for cardiovascular events. Patients were randomly assigned to receive empagliflozin 10 or 25 mg or placebo. Incident or worsening nephropathy and rates of renal replacement therapy were all significantly lower in the empagliflozin group.

FDA Releases a Drug Safety Communication With Strengthened Kidney Warnings for Canagliflozin and Dapagliflozin

June 14, 2016. The US Food and Drug Administration has strengthened an existing warning regarding the risk of acute kidney injury with use of the sodium-glucose cotransporter-2 inhibitor medicines canagliflozin and dapagliflozin for the treatment of type 2 diabetes. Specifically, the FDA has revised the warning section of the canagliflozin and dapagliflozin drug labels to include information about acute kidney injury and recommendations to minimize this risk.

Cardiovascular Mortality in Patients With Type 2 Diabetes and Recent Acute Coronary Syndrome

This study—Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE)—evaluated the risk of cardiovascular (CV) death in all EXAMINE study participants compared with patients who experienced a major, nonfatal CV event during the EXAMINE study period. Patients with type 2 diabetes (N=5,380) who had experienced an acute coronary syndrome within the past 15 to 90 days were assigned to treatment with alogliptin or placebo. Outcomes evaluated included CV death and other nonfatal CV events.