In The News

Exenatide Plus Dapagliflozin Significantly Reduces A1C Compared to Either Drug Alone: DURATION-8 Results

December 2016. This randomized controlled trial examined the effect on A1C of exenatide plus dapagliflozin compared with either drug alone. Over 28 weeks, among patients with type 2 diabetes, exenatide plus dapagliflozin reduced A1C by 2.0%. This was significant versus a reduction of 1.6% in the exenatide group (95% confidence interval [CI], −0.6 to −0.1; P=0.004), and compared to a reduction of 1.4% in the dapagliflozin group (95% CI, –0.8 to −0.3; P<0.001).

Semaglutide and Cardiovascular Outcomes in Patients With Type 2 Diabetes

November 10, 2016. This randomized controlled trial evaluated the cardiovascular (CV) impact of semaglutide, a long-acting glucagon-like peptide-1 (GLP-1) analogue. Investigators in the SUSTAIN-6 study assigned 3297 patients to receive once-weekly semaglutide 0.5 mg or 1.0 mg or placebo for 104 weeks. At baseline, 83% of patients had established CV disease and/or chronic kidney disease. The primary composite outcome was the first occurrence of CV death, nonfatal myocardial infarction, or nonfatal stroke.

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

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.