In The News

FDA Approves Bydureon Add-On Therapy for Adults With Type 2 Diabetes

April 3, 2018. The US Food and Drug Administration has approved the use of Bydureon—extended-release exenatide—as add-on therapy to basal insulin in adults with type 2 diabetes (T2D) with poor glycemic control. This expanded indication is based on data from the DURATION-7 study, which evaluated Bydureon vs placebo as add-on therapy to insulin glargine in patients with T2D. In this study, mean A1C was reduced by 0.9% in the Bydureon group compared with 0.2% in the placebo group; similar rates of hypoglycemia were reported for both groups.

FDA Committee Recommends Approval of Continuous Glucose Monitor That Can Be Implanted for 3 Months

March 29, 2018. A US Food and Drug Administration advisory committee has voted unanimously to recommend approval of a continuous glucose monitor (CGM) that can be worn for up to 90 days. The device, the Eversense CGM, is manufactured by Senseonics. It is a small, fluorescence-based glucose sensor that can be implanted in the patient’s upper arm and paired with a transmitter to provide real-time data using a smartphone app.

Dexcom to Launch New Continuous Glucose Monitor

March 27, 2018. Dexcom has received US Food and Drug Administration approval for its new G6 real-time continuous glucose monitor, with an expected US launch between April and June of this year. The G6 is factory-calibrated and does not require a fingerstick. It can be worn continuously for up to 10 days, does not interfere with acetaminophen, and is approved for patients aged 2 years and older. The hardware includes a new one-button insertion, and the device is about two-thirds the original size.

FDA Clears 900-Unit Insulin Glargine Pen

March 27, 2018. The US Food and Drug Administration has cleared Sanofi’s new 900-unit insulin glargine pen, the Max SoloStar. With a higher capacity than any other long-acting insulin pen on the market, the Max SoloStar pen provides up to 160 units/mL of insulin glargine in a single injection. This means fewer injections, refills, and related copays for some patients, which could ease both the injection and financial burden of living with diabetes.

Cohort Study Identifies Patient Characteristics Associated With Severe Hypoglycemia

March 16, 2018. A retrospective cohort study using electronic medical records of 50,439 patients with type 2 diabetes in the Cleveland Clinic Health System was conducted between 2006-2015 to identify severe hypoglycemia events and associated risk factors. Incidence of severe hypoglycemia, defined as hospitalizations or emergency department visits for hypoglycemia, increased from 2006 to 2015 from 0.12% to 0.31% (P = 0.01).

IDegLira Is Effective in a Real-World Type 2 Diabetes Population

January 11, 2018. A European, retrospective chart review of adults (N=611) with type 2 diabetes evaluated the effect of IDegLira (a fixed-ratio combination of insulin degludec/liraglutide) on A1C, body weight, and other clinical characteristics ≥6 months after treatment initiation. Patients were stratified according to their baseline regimens: non-injectable therapies; glucagon-like peptide-1 receptor agonists (GLP-1 RAs) + oral antidiabetic drugs (OADs); combination insulin/GLP-1 RA + OADs; basal insulin + OADs; and multiple daily insulin injections (MDI) + OADs.

Several Diabetes Organizations Disagree With the American College of Physicians’ Recent Guidance on Blood Glucose Targets

March 9, 2018. The American Association of Clinical Endocrinologists (AACE), American Diabetes Association (ADA), American Association of Diabetes Educators (AADE), and The Endocrine Society (TES) have issued a statement strongly disagreeing with the recent guidance from the American College of Physicians (ACP) for A1C targets of 7% to 8% in adults with type 2 diabetes. This higher blood glucose target may put many patients at increased risk of complications, including cardiovascular disease, retinopathy, kidney disease, and amputation.

Diabetes Prevalence, Deaths, and Health Care Expenditures Worldwide: Estimates From the International Diabetes Foundation

February 26, 2018. The International Diabetes Foundation (IDF) performed a systematic literature review of studies published from 1990 to 2016 to estimate the 2017 worldwide prevalence of adult deaths attributable to and health care expenditures associated with impaired glucose tolerance (IGT), diabetes, and hyperglycemia in pregnancy. The IDF found that approximately 374 million adults have IGT and an estimated 451 million are living with diabetes. About 21.3 million live births in 2017 were to women with hyperglycemia.

Dulaglutide Superior to Placebo when Added to a Sodium Glucose Cotransporter-2 Inhibitor

February 23, 2018. The Assessment of Weekly AdministRation of LY2189265 (dulaglutide) in Diabetes-10 (AWARD-10) trial, a 24-week, phase 3b, double-blind, parallel-arm, placebo-controlled study, found the glucagon-like peptide-1 receptor agonist dulaglutide 1.5 mg (n=142) and 0.75 mg (n=142) significantly superior to placebo (n=140) in lowering A1C when added to any sodium glucose cotransporter-2 (SGLT-2) inhibitor, with or without metformin, in patients with uncontrolled type 2 diabetes.

Semaglutide Shows Greater Glycemic Control and Reduction in Body Weight Than Dulaglutide

January 31, 2018. This randomized, open label, parallel-group, phase 3b clinical trial evaluated the impact of dulaglutide vs semaglutide (both dipeptidyl peptidase-4 inhibitors) on A1C and body weight. For 40 weeks, participants with type 2 diabetes received either dulaglutide 0.75 mg (n=299), dulaglutide 1.5 mg (n=299), semaglutide 0.5 mg (n=301), or semaglutide 1.0 mg (n=300) in addition to metformin.

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