In The News

Lipid-Lowering Efficacy of the PCSK9 Inhibitor Evolocumab (AMG 145) in Patients With Type 2 Diabetes

May 2016. This random-effects meta-analysis evaluated data from randomized controlled trials to assess the efficacy of the PCSK9 inhibitor evolocumab, compared with placebo and ezetimibe, in improving lipid profiles in patients with and without type 2 diabetes (T2D). Three trials were suitable for evaluation; they included 413 patients with T2D and 2119 patients without T2D. In patients with T2D, evolocumab was associated with mean low-density lipoprotein cholesterol (LDL-C) reductions of 60% vs placebo and 39% vs ezetimibe.

FDA Adds Warnings About Heart Failure Risk to Labels of Drugs Containing Saxagliptin and Alogliptin

April 5, 2016. A US Food and Drug Administration (FDA) safety review has found that saxagliptin and alogliptin, 2 dipeptidyl peptidase-4 inhibitor medications used to treat type 2 diabetes, may increase heart failure risk, particularly in patients with existing cardiovascular or kidney disease. Therefore, the FDA is adding warnings to these drug’s labels regarding the potential for increased heart failure. The FDA recommends that health care professionals consider discontinuing these medications in patients who develop heart failure.

FDA Revises Warnings Regarding Use of Metformin in Certain Patients With Reduced Kidney Function

April 8, 2016. The US Food and Drug Administration (FDA) is requiring labeling changes for metformin-containing medicines for diabetes, expanding the drug’s use in certain patients with impaired renal function. The current metformin labeling strongly recommends against use in patients with impaired kidney function. However, following a review of numerous medical studies, the FDA has concluded that metformin can be used safely in patients with mild renal impairment and in some patients with moderate renal impairment.

Impact of CMS Competitive Bidding Program on Medicare Beneficiary Safety and Access to Diabetes Testing Supplies

March 18, 2016. This retrospective, longitudinal analysis evaluated US Centers for Medicare & Medicaid Services (CMS) claims data (2009-2012) to confirm a 2012 CMS report indicating no acquisition disruptions or changes in health outcomes due to the rollout of the CMS Competitive Bidding Program (CBP) for diabetes supplies. The study population comprised 43,939 beneficiaries in the 9 test markets originally targeted by the CBP (TEST group) and 485,688 beneficiaries in non-test markets (NONTEST group); all patients were insulin users.

Glucose Variability: Timing, Risk Analysis, and Relationship to Hypoglycemia in Diabetes

April 2016. This “Perspective” article from Diabetes Care discusses the close relationship between glucose control, glucose variability (GV), and hypoglycemia. The authors emphasize that diabetes control requires optimization and balance between 2 key markers: hypoglycemia frequency and A1C levels (reflecting average blood glucose, primarily driven by the extent of hyperglycemia). They stress the need to standardize GV measurement to improve patient assessment. Follow this link to read the study abstract.

Hypoglycemia Requiring Medical Intervention in a Large Cohort of Adults With Diabetes Receiving Care in US Integrated Health Care Delivery Systems

March 2016. This study evaluated the burden of severe hypoglycemia requiring medical intervention in 917,440 adults with diabetes receiving care between 2005 and 2011 at SUPREME-DM (Surveillance, Prevention, and Management of Diabetes Mellitus) sites. Data were obtained from inpatient and emergency room records. Investigators found annual rates of severe hypoglycemia ranging from 1.4 to 1.6 events per 100 person-years.

Effects of Sodium-Glucose Cotransporter-2 Inhibitors on Cardiovascular Events, Death, and Major Safety Outcomes in Adults With Type 2 Diabetes

March 18, 2016. This systematic review and meta-analysis was conducted to assess the effect of sodium-glucose cotransporter-2 (SGLT-2) inhibition on cardiovascular (CV) events, death, and safety outcomes in patients with type 2 diabetes (T2D). Following a thorough literature search, final data evaluated included 6 regulatory submissions (N=37,525 patients) and 57 published trials (N=33,385), representing 7 SGLT-2 inhibitor drugs.

Polypharmacy in the Aging Patient: A Review of Glycemic Control in Older Adults With Type 2 Diabetes

March 8, 2016. This review was conducted to help clarify the substantial uncertainty surrounding type 2 diabetes treatment in older adults. Specifically, it evaluated data from 4 large randomized clinical trials (selected because they provide the majority of evidence used to guide diabetes therapy). The authors noted a lack of data in patients older than 80 years of age. Additionally, among patients provided with intensive glycemic control, observable improvements in micro- and macrovascular complications were not observed for 8-10 years.

Effect of CPAP on Glycemic Control in Patients with Obstructive Sleep Apnea and Type 2 Diabetes. A Randomized Clinical Trial

February 24, 2016. This 6-month, open-label, parallel-arm, randomized clinical trial allocated 50 patients with obstructive sleep apnea, type 2 diabetes (T2D), and A1C levels ≥6.5% to treatment with continuous positive airway pressure (CPAP) or no CPAP for 6 months. The study objectives were to evaluate the impact of CPAP on patient A1C levels, as well as the determinants of benefits observed. Specifically, investigators measured Homeostasis Model Assessment and Qualitative Insulin Sensitivity Check Index scores, as well as systemic biomarkers.

Long-term Metformin Use and Vitamin B12 Deficiency in the Diabetes Prevention Program Outcomes Study

February 22, 2016. This secondary analysis of data from the Diabetes Prevention Program Outcomes Study (DPPOS) followed patients for approximately 13 years to assess the risk of vitamin B12 deficiency with long-term metformin use. Investigators found that low B12 levels (≤203 pg/mL) were significantly more common at 5 years in patients taking metformin versus placebo (4.3% vs 2.3%, P=0.02), but not at 13 years (7.4% vs 5.4%, P=0.12).

AACE Consensus Conference on Continuous Glucose Monitoring Issues Statement

March 2016. Participants in a recent Consensus Conference on Continuous Glucose Monitoring (CGM) held by the American Association of Clinical Endocrinologists (AACE) agreed that access to CGM should be available to all patients who could benefit from it. The conference addressed 4 key questions related to CGM technology: 1) physician/patient benefit from expanded CGM use; 2) the relevance and reporting of CGM data; 3) interpretation and reporting of CGM data; and 4) currently available clinical data.

AACE/ACE Release Their 2016 Outpatient Glucose Monitoring Consensus Statement

February 10, 2016. The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have announced the publication of their outpatient glucose monitoring consensus statement. The statement provides detailed analyses to support precise recommendations for the type of system and frequency of use for either self-monitoring blood glucose therapy or continuous glucose monitoring to reduce short- and long-term complications of diabetes.

December 9

The AACE Diabetes Resource Center is a compendium of educational tools that enable AACE members to take the lead in implementation of diabetes practice guidelines and also assist other members of their healthcare team in the formulation and delivery of education and guidelines with the goal of improving care for patients with diabetes in their communities.