In The News

Diabetes Drug (Liraglutide) Makes NASH Vanish in Some Patients

Research findings presented at the 2015 International Liver Conference In Vienna indicate that treating patients with injectable liraglutide provides substantial clinical response and reduced fibrosis in patients with nonalcoholic steatohepatitis (NASH). In this double-blind, randomized trial, 52 patients with obesity and biopsy-demonstrated NASH were assigned to receive once-daily injections of liraglutide 1.8 mg or placebo.

US Centers for Disease Control and Prevention Announces Prediabetes Initiative

The US Centers for Disease Control is working with the American Medical Association to encourage physicians to recruit Americans living with prediabetes into evidence-based prevention programs to decrease their risk of progression to type 2 diabetes.

FDA Panel Backs Safety Updates for Saxagliptin and Alogliptin

An advisory committee to the U.S. Food and Drug Administration (FDA) has indicated that the labels for the dipeptidyl peptidase-4 inhibitor drugs saxagliptin and alogliptin should carry information about the potential risk of heart failure (HF) with these medications. This recommendation was based on information obtained from long-term cardiovascular follow-up studies, which found that neither drug was associated with an increased risk of overall cardiovascular death, stroke, or myocardial infarction.

Screening for Type 2 Diabetes Mellitus: A Systematic Review for the U.S. Preventive Services Task Force

This document provides an update to the 2008 U.S. Preventive Services Task Force review on diabetes screening in adults. Following a comprehensive literature review, investigators found that available data suggest no 10-year mortality benefit to accompany diabetes screening. Additionally, trials of patients with impaired glucose tolerance and/or impaired fasting glucose indicate that treating these conditions is associated with reduced progression to type 2 diabetes.

American Association of Clinical Endocrinologists/American College of Endocrinology Release New, Comprehensive Clinical Practice Guidelines and Updated Algorithm for Developing a Comprehensive Diabetes Mellitus Care Plan

AACE/ACE announced the publication its new diabetes clinical practice guidelines and updated diabetes algorithm to assist clinical caregivers with the medical management of patients with diabetes mellitus. These substantially modified guidelines advocate for comprehensive diabetes control beyond glycemic control, addressing multiple risk factors. The AACE/ACE guidelines promote individual patient goals and the development of personalized management plans.

The Effect of Dapagliflozin on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes

This multicenter, randomized, double-blind, placebo-controlled trial was developed to assess the efficacy and safety of dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, vs placebo over 24 weeks, with a 28-week extension period. Patients (N=922) had type 2 diabetes, preexisting cardiovascular disease, and a history of hypertension; they were allocated to treatment with dapagliflozin 10 mg or placebo. Among patients receiving insulin, the dose was reduced by 25% at randomization.

Insulin Pump Risks and Benefits: A Clinical Appraisal of Pump Safety Standards, Adverse Event Reporting, and Research Needs

The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group have published a joint statement on the topic of insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII). Because available evidence on the safety and efficacy of CSII remains limited, the EASD and ADA have collaborated to review systems in place for evaluating pump safety from a clinical perspective.

Gender-Based Differences in Glycemic Control and Hypoglycemia Prevalence in Patients With Type 2 Diabetes

This study evaluated the impact of gender on glycemic control and hypoglycemia using pooled data from 6 randomized clinical trials of insulin glargine or NPH insulin in insulin-naïve patients with type 2 diabetes. Both males and females had similar baseline A1C levels and diabetes duration (~8.9% and ~10 years) and were followed for 24-36 weeks following insulin initiation.

2 Treatment Approaches for Human Regular U-500 Insulin in Patients With Type 2 Diabetes Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy With or Without Oral Agents: A Randomized, Titration-to-Target Clinical Trial

This 24-week, open-label, parallel trial compared the efficacy and safety of 2 dosing regimens of human regular U-500 insulin, used to replace high-dose U-100 insulin. The patient population was 325 patients with inadequately controlled type 2 diabetes (T2D). At baseline, mean patient A1C was 8.7%, and U-100 insulin dose was 287.5 units administered over 5 daily injections. Patients were randomized to treatment with twice- or thrice-daily U-500R (BID, TID); the primary outcome was A1C reduction from baseline.

FDA Approves New Treatment for Diabetic Retinopathy in Patients With Diabetic Macular Edema

The U.S. Food and Drug Administration (FDA) has expanded the approved use for aflibercept injection (Eylea) to treat diabetic retinopathy (DR) in patients with diabetic macular edema. Aflibercept is administered by injection into the eye once monthly for 5 months and subsequently once every 2 months. The drug’s safety and efficacy were evaluated in 679 patients in 2 clinical studies; patients were randomly assigned to receive aflibercept or macular laser photocoagulation.

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