In The News

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.

Dapagliflozin Lowers Plasma Glucose Concentration and Improves Beta Cell Function

March 2015. This study was designed to examine the effects of the sodium glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin on beta cell function in patients with type 2 diabetes mellitus (T2DM). Twenty-four individuals with T2DM received dapagliflozin or placebo for 2 weeks, with a 75-gram oral glucose tolerance test (OGTT) and insulin clamp performed before and after treatment. During the OGTT, plasma glucose, insulin, and C-peptide concentrations were also measured.

Surge in Newly Identified Diabetes Among Medicaid Patients in 2014 Within Medicaid Expansion States Under the Affordable Care Act

March 22, 2015. Pursuant to the Affordable Care Act (ACA), 26 states and the District of Columbia expanded Medicaid in January 2014, while 24 states did not. Investigators identified the number of patients with newly identified diabetes among enrollees aged 19 to 64 years in states that expanded Medicaid vs those that did not. In the states that expanded Medicaid, the number of Medicaid-enrolled patients with newly identified diabetes increased by 23% (14,625 vs 18,020), compared with an increase of 0.4% (11,612 vs 11,653 patients) in the states that did not expand Medicaid.

Efficacy and Safety of Saxagliptin in Older Participants in the SAVOR-TIMI 53 Trial

March 10, 2015. This retrospective analysis was conducted to examine the safety and cardiovascular (CV) effects of saxagliptin in elderly (≥65 years, n=8561) and very elderly (≥75 years, n=2330) patients who participated in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) trial. The primary endpoint was a composite of CV mortality, myocardial infarction, or ischemic stroke; patients were followed for a median of 2.1 years.

Heart Failure and Mortality Outcomes in Patients With Type 2 Diabetes Taking Alogliptin Versus Placebo in EXAMINE

Concerns have been reported regarding excessive rates of in-hospital heart failure (HF) with DPP-4 inhibitors. This evaluation of data from EXAMINE, a multicenter, randomized, double-blind trial, assessed HF-related hospital admission rates in patients assigned to treatment with alogliptin (n=2701) or placebo (n=2679) and followed for a median of 533 days.

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