In The News

Initial Combination of Empagliflozin and Metformin in Patients With Type 2 Diabetes

October 2016. This 24-week randomized study compared the efficacy and safety of initial type 2 diabetes therapy with metformin (MET), the sodium glucose co-transporter-2 inhibitor empagliflozin (EMP), or both treatments. Drug-naïve patients (N=1364) were randomized to 8 treatment groups: EMP 12.5 mg bid + MET 1000 mg bid; EMP 12.5 mg bid + MET 500 mg bid; EMP 5 mg bid + MET 1000 mg bid; EMP 5 mg bid + metformin 500 mg bid, EMP 25 mg qd; EMP 10 mg qd; MET 1000 mg bid; or MET 500 mg bid. The primary endpoint was change in A1C levels from baseline (mean baseline level: 8.6% to 8.9%).

Exenatide Once Weekly Plus Dapagliflozin Once Daily Versus Exenatide or Dapagliflozin Alone in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy (DURATION-8)

September 2016. This 28-week, multisite, double-blind phase 3 randomized controlled trial evaluated the efficacy and safety of add-on therapy with the glucagon-like peptide-1 receptor agonist exenatide (EXE) and the sodium glucose co-transporter-2 inhibitor dapagliflozin (DAP) in patients with type 2 diabetes, taking metformin ≥1500 mg/day, with uncontrolled glycemia (A1C 8% to 12%). EXE once weekly and DAP once daily were added separately or simultaneously in 1:1:1 randomization, with patients (N=695) adding EXE, DAP, or both to their current regimen.

Severe Hypoglycemia in Patients With Known Diabetes Requiring Emergency Department Care

This multicenter Italian study was conducted to describe the characteristics and associated risk factors of patients with established diabetes who required emergency department care for severe hypoglycemia. A total of 520 patients were identified; the majority had frailty and multiple comorbidities; 43.6% were being treated with oral antihyperglycemic drugs alone, 42.8% with insulin alone, and 13.6% with both. Glibenclamide and repaglinide were the most commonly used oral drugs. Approximately one-third (35.4%) of patients required hospitalization, and in-hospital death rates were 2.3%.

Dapagliflozin QD and Exenatide QW Dual Therapy: A 24-Week Randomized, Placebo-Controlled, Phase 2 Study Examining Effects on Body Weight and Prediabetes in Obese Nondiabetic Adults

August 23, 2016. This single-center, double-blind trial evaluated the use of dapagliflozin plus exenatide on body weight, body composition, glucose parameters, and systolic blood pressure (SBP) in patients with obesity but no diabetes. Fifty adults were randomized (age 18–70 years; body mass index 30–45 kg/m2) to dapagliflozin 10 mg once daily plus long-acting exenatide 2 mg once weekly, or placebo. After 24 weeks, the difference in body weight loss between dapagliflozin/exenatide vs placebo was −4.13 kg (95% confidence interval: −6.44, −1.81; P<0.001).

Hypoglycemia When Adding Sulfonylureas to Metformin

August 3, 2016. This systematic review and network meta-analysis was conducted to compare the relative risk of hypoglycemia when adding next-generation sulfonylureas (SUs) to metformin in patients with type 2 diabetes. Thirteen trials of SU therapy and 14 trials of non-SU therapy were analyzed. Investigators found that, compared with glipizide, the odds ratio (OR) for hypoglycemia was lowest with gliclazide (0.22, confidence interval 0.05-0.96), followed by glimepiride (0.40, 0.13-1.27) and glibenclamide (0.21, 0.03-1.48).

Risk of Cause-Specific Death in Individuals With Diabetes: A Competing Risks Analysis

August 2016. This pooled analysis of 55,292 individuals was conducted using data from a series of Spanish population cohorts to determine the association between type 2 diabetes (T2D) and cause-specific death over 10 years. Participants were required to have no prior history of cardiovascular (CV) disease and to be 35 to 79 years of age.

Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes

July 28, 2016. This analysis of the (Empaglifozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) trial evaluated the long-term renal effects of empagliflozin in patients with type 2 diabetes. Prespecified renal endpoints included: a) incident or worsening nephropathy (progression to macroalbuminuria, doubling of serum creatinine, renal replacement therapy initiation, or death from renal disease); and, b) incident albuminuria.

FDA Approves Lixisenatide (Adlyxin) to Treat Type 2 Diabetes

July 28, 2016. The US Food and Drug Administration has approved the glucagon-like peptide-1 receptor agonist lixisenatide (Adlyxin) as a once-daily injection to improve glycemic control in adults with type 2 diabetes. Click here for full article

A Population-Based Study of All-Cause Mortality and Cardiovascular Disease in Association With Prior History of Hypoglycemia Among Patients With Type 1 Diabetes

July 2016. This study investigated the effects of severe hypoglycemia on all-cause mortality and cardiovascular disease (CVD) incidence in patients with type 1 diabetes (T1D). The study comprised 2 nested case-control studies (total cohort N=10,411) and used a time-density sampling method to identify age- and sex-matched controls between 1997 and 2011. Severe hypoglycemia history was identified within 1, 1 to 3, and 3 to 5 years before the occurrence of study outcomes.

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.

AACE Resource Center

The AACE Diabetes Resource Center is a compendium of educational tools that enable AACE members to take the lead in implementation of diabetes practice guidelines and also assist other members of their healthcare team in the formulation and delivery of education and guidelines with the goal of improving care for patients with diabetes in their communities.