In The News

Urinary Tract and Genital Infections in Patients With Type 2 Diabetes Treated With Sodium-Glucose Cotransporter 2 Inhibitors

November 12, 2016. This meta-analysis of randomized controlled trials (RCTs) evaluated the risk of urinary tract infection (UTIs) and genital infection in patients with type 2 diabetes using sodium-glucose cotransporter 2 (SGLT-2) inhibitors. A total of 52 RCTs involving 36,689 patients were eligible for inclusion, and all drug formulations and dosages were evaluated.

Walking After Meals Is Particularly Effective for Lowering Postprandial Glucose

October 17, 2016. This randomized crossover study evaluated whether the timing of walks in relation to meals improves postprandial glucose. Over a 2-week period, 41 adults with type 2 diabetes (mean age 60 years) were advised to either walk 30 minutes each day or for 10 minutes after each main meal. Participants’ physical activity was measured by accelerometry, and glucose levels were measured using continuous glucose monitoring. Postprandial glucose was assessed over the 3 hours after a meal using the incremental area under the blood glucose curve (iAUC).

Cardiovascular Autonomic Neuropathy and Cardiovascular Outcomes in the DCCT/EDIC Study

November 2016. This analysis of patients in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) evaluated whether cardiovascular autonomic neuropathy (CAN) is an independent risk factor for cardiovascular disease (CVD). A series of standardized cardiovascular autonomic reflex tests was performed at DCCT baseline, every 2 years during the DCCT, and at 2 times during EDIC follow-up.

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

October 17, 2016. 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%).

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