In The News

FDA Approves Empagliflozin to Reduce Cardiovascular Death in Adults With Type 2 Diabetes

December 2, 2016. The US Food and Drug Administration has approved a new indication for empagliflozin to reduce the risk of cardiovascular (CV) death in adult patients with type 2 diabetes (T2D) and cardiovascular disease. This decision is based on a postmarketing study of more than 7,000 patients with T2D and CV disease. This study found that empagliflozin reduced the risk of CV death vs placebo when added to standard of care therapies for diabetes and atherosclerotic CV disease. Click here for full article

FDA Approves One Drop Chrome Mobile Blood Glucose Monitoring System

December 6, 2016. The US Food and Drug Administration has approved the mobile blood glucose (BG) monitoring system One Drop Chrome and a subscription upgrade service, One Drop Premium. The One Drop Chrome device wirelessly transmits BG data directly via the One Drop app (available on both iOS and Android). The app can be used to log information related to glucose, diet, activity, and insulin. The platform offers users actionable insights based on their data.

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

This randomized controlled crossover study examined the effect of liraglutide on 24-h urinary albumin excretion rate (UAER) among patients with type 2 diabetes and persistent albuminuria (urinary albumin-to-creatinine ratio >30 mg/g) and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2. After placebo treatment, geometric mean (IQR) UAER was 199 (81-531) mg/24-h, mean measured GFR (mGFR) was 75 mL/min/1.73 m2, 24-h systolic blood pressure (SBP) was 145/80 mm Hg, and A1C was 7.7%.

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.

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