In The News

FDA Approves New, Once-Weekly Extended-Release Exenatide Injection

October 23, 2017. The US Food and Drug Administration (FDA) has approved a new, extended-release formulation of exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, for adults with type 2 diabetes. The new formulation, called Bydureon BCise, is delivered via a once-weekly, single-dose autoinjector device that continuously releases consistent, therapeutic levels of exenatide. In clinical trials, the drug has been shown to lower A1C levels and promote weight loss, both as monotherapy and in combination with metformin, a sulfonylurea, or a thiazolidinedione.

Semaglutide Receives Votes in Favor of Approval From the FDA

October 18, 2017. An advisory committee of the US Food and Drug Administration (FDA) voted to recommend approval of Novo Nordisk’s semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA), to improve glycemic control in adults with type 2 diabetes (T2D). The decision was based on efficacy and safety data from 8 clinical trials, which involved more than 8,000 adults with T2D.

Empagliflozin Improves Urinary Albumin Excretion in Patients With Type 2 Diabetes

August 5, 2017. The effect of empagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, on urinary albumin-to-creatinine ratio (UACR) was explored in an analysis of data from EMPA-REG OUTCOME, a randomized, placebo-controlled trial. In the exploratory analysis, 6,953 patients were stratified according to albuminuria status at baseline (normo-, micro-, or macroalbuminuria) and data were pooled for the empagliflozin arms (10 and 25 mg) vs placebo. UACR levels were assessed at 12 and 164 weeks.

Glycaemic Control and Hypoglycemia in Patients With Type 2 Diabetes Switching From Twice-Daily Basal Insulin to Once-Daily Insulin Glargine 300 U/mL or Insulin Glargine 100 U/mL

July 24, 2017. This post-hoc analysis of 2 large, randomized controlled trials (EDITION 1 and EDITION 2) evaluated the effect of once-daily insulin glargine 300 U/mL (Gla-300) vs glargine 100 U/mL (Gla-100) over 6 months on blood glucose and hypoglycemia in patients with type 2 diabetes switching from twice-daily insulin. Change from baseline in A1C, assessed as least-squares mean difference, was similar for both groups in both studies: (EDITION 1, -0.01%; 95% confidence interval [CI]: -0.27%-0.24%; EDITION 2, 0.16%; 95% CI: -0.25%-0.57%).

FDA Approves a New, Faster-Acting Mealtime Insulin for Adults With Type 1 and Type 2 Diabetes

October 3, 2017. The US Food and Drug Administration (FDA) has approved a new, faster-acting injected mealtime insulin called Fiasp ("fast-acting insulin aspart"). Fiasp is similar to the mealtime insulin NovoLog but with a quicker onset and offset; Fiasp can be used as late as 20 minutes after starting a meal (although before-meal administration is preferable), and the more rapid offset reduces the risk of post-meal hypoglycemia. Fiasp will be offered at the same price as NovoLog.

FDA Approves the FreeStyle Libre Flash Glucose Monitoring System for Adults With Diabetes

September 27, 2017. The US Food and Drug Administration (FDA) has approved the first continuous glucose monitoring system that does not require a "fingerstick" blood sample. The FreeStyle Libre Flash Glucose Monitoring System uses a small sensor wire inserted below the skin's surface. By waving a mobile reader above the sensor, a user can determine if glucose levels are too high or low, as well as see changes in glucose levels that can inform diabetes treatment decisions. The system can be worn for up to 10 days after a 12-hour start-up period.

Evolocumab Is Effective and Safe for People With and Without Diabetes

September 15, 2017. Evolocumab is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor that reduced cardiovascular (CV) events and low-density lipoprotein cholesterol over a median of 2.2 years in the randomized FOURIER trial (N=27,564). This prespecified post-hoc analysis investigated the efficacy and safety of evolocumab vs placebo among patients with (n=11,031) and without diabetes (n=16,533) at baseline. The impact of evolocumab on the risk of developing diabetes also was investigated.

Empagliflozin Improves Clinical Outcomes and Reduces Mortality in Patients With Diabetes, Cardiovascular Disease, and Chronic Kidney Disease

September 13, 2017. The EMPA-REG OUTCOME trial investigated the impact of empagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, on 7,020 patients with type 2 diabetes (T2D) and cardiovascular (CV) disease. This analysis of a subset of patients with T2D, CV disease, and chronic kidney disease at baseline found that empagliflozin is not only safe, but improves clinical outcomes and reduces mortality when added to standard of care treatment.

DEPICT-1 Trial: Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes

September 14, 2017. This 24-week double-blind, multicenter, randomized controlled trial evaluated the safety and efficacy of the sodium-glucose cotransporter-2 inhibitor dapagliflozin in patients with type 1 diabetes (T1D) not adequately controlled on insulin therapy. Patients were randomly assigned to receive dapagliflozin 5 mg or 10 mg, or placebo. The primary endpoint was A1C reduction from baseline. At 24 weeks, the mean A1C difference from baseline vs placebo was -0.42% and -0.45% for dapagliflozin 5 and 10 mg, respectively (P<0.0001 for both).

DURATION-8 Trial: Efficacy and Safety of Once-Weekly Exenatide Plus Once-Daily Dapagliflozin vs Exenatide or Dapagliflozin Alone

September 13, 2017. This 28-week double-blind, multicenter, randomized controlled trial evaluated the efficacy of once-weekly exenatide 2 mg (EXE) with or without dapagliflozin 10 mg (DAPA) in patients with type 2 diabetes inadequately controlled on metformin alone. Participants were randomized to receive EXE + DAPA, EXE + oral placebo, or DAPA + injected placebo; the study also included a 24-week extension phase.

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