In The News

FDA Issues Recommendations for Industry to Improve Blood Glucose Monitoring Test Systems

October 11, 2016. The US Food and Drug Administration has released a final guidance document: “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use” (ie, home use). Its purpose is to improve new blood glucose meters by providing manufacturers with recommendations regarding the types of studies and information to include in premarket 510(k) submissions for these devices.

The Effect of Liraglutide on Renal Function: a Randomized Clinical Trial

This 12-week randomized, double-blind, placebo-controlled trial evaluated the renal effects of the glucagon-like peptide-1 agonist liraglutide in patients with type 2 diabetes (T2D) and albuminuria who were receiving multifactorial care. The primary endpoint was 24-hour geometric mean (IQR) urinary albumin excretion rate (UAER) change; 32 patients were randomized to liraglutide 1.8 mg/day or placebo.

Comparing the Clinical Effects of Short- or Long-Acting GLP-1 Receptor Agonists vs Insulin Treatment From Head-to-Head Studies in Patients with Type 2 Diabetes

October 7, 2016. This meta-analysis evaluated clinical outcomes in patients with type 2 diabetes currently being treated with oral glucose-lowering medications who received add-on therapy with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) vs insulin therapy. Twenty-three publications summarizing 19 clinical trials were identified for use. Investigators found that, compared with insulin, GLP-1 RAs led to greater absolute reductions in A1C levels (0.17%), body weight (3.71 kg), and hypoglycemic episodes (34%; P< 0.0001 for all comparisons).

FDA Finalizes 2 Blood Glucose Monitoring System Guidance Documents

October 11, 2016. The US Food and Drug Administration has finalized 2 guidance documents related to blood glucose monitoring systems. These guidelines have been developed to provide recommendations regarding the information to be provided in 510(k) submissions for blood glucose monitoring systems used by health care professionals vs blood glucose self-monitoring systems used by patients. Click here for full article

FDA Clears Abbott’s Freestyle LIbre Pro, a Needle-Free Continuous Glucose Monitoring System, for Professional Use

September 29, 2016. The US Food and Drug Administration has approved Abbott’s Freestyle Libre Pro System for professional continuous glucose monitoring (CGM). According to Abbott, the device provides clinicians with 14 days of patient data, does not require finger-stick calibrations, and is significantly more affordable than competitive CGM models. Additionally, physician offices can purchase one system and use it to scan multiple patients.

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).