In The News

Years of Life Gained by Multifactorial Intervention in Patients With Type 2 Diabetes Mellitus and Microalbuminuria: 21 Years Follow-Up on the Steno-2 Randomized Trial

October 2016. This study evaluated the long-term impact of the 7.8-year Steno-2 study, initiated in 1993 to assess the impact of an intensified, multifactorial intervention (addressing hyperglycemia, adiposity, hypertension, dyslipidemia, and increased blood platelet aggregation) in patients with type 2 diabetes and microalbuminuria. In the current study, patients were observed for a median 13.4 years after the conclusion of Steno-2 interventions.

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.