In The News

Leading Medical Association Announces Scientific and Clinical Review of Potential Relationship Between Diabetes Ketoacidosis and SGLT2 Inhibitors

The American Association of Clinical Endocrinologists (AACE), the leading medical organization representing more than 6000 experts in the care and treatment of diabetes patients, today announced plans to convene a conference of US and international experts to examine the issue of diabetic ketoacidosis (DKA) among patients treated with SGLT2 inhibitors, a class of medications approved for use in adults with type 2 diabetes. AACE will conduct this meeting to provide answers to questions from its membership raised in response to recent case reports and publications on the subject.

Dapagliflozin’s Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes

This 24-week, multicenter, randomized, double-blind, placebo-controlled study with a 28-week extension was developed to assess the efficacy and safety of the selective sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin 10 mg vs placebo in patients with type 2 diabetes, preexisting cardiovascular disease, and a history of hypertension. Co-primary endpoints were A1C reduction from baseline and the proportion of patients achieving a combined endpoint involving reductions in the following parameters: A1C ≥0.5%, body weight ≥3%, and systolic blood pressure ≥3 mm Hg.

New Position Statement: Diabetes Self-management Education and Support in Type 2 Diabetes

The American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics have released a joint position statement on diabetes self-management education and support (DSME/S) for patients with type 2 diabetes. The statement provides an algorithm to guide providers on when to refer patients for education and support, and highlights 4 critical times for assessing the need for DSME/S: at patient diagnosis; annually; when new disease complications affect disease management; and, when transitions in care occur.

Biomarkers Related to Severe Hypoglycemia and Lack of Good Glycemic Control in ACCORD

Biomarkers Related to Severe Hypoglycemia and Lack of Good Glycemic Control in ACCORDJune 2015. This study was developed to identify blood biomarkers that predict the success of glycemic control intensification in patients with type 2 diabetes. Investigators used a nested, case-control design to compare case (n=326) and control (n=1075) patients using data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study.

Veterans Affairs Diabetes Trial: Follow-up of Glycemic Control and Cardiovascular Outcomes in Type 2 Diabetes

Previously, the 5.6-year Veterans Affairs Diabetes Trial (VADT) found that intensive glucose lowering did not significantly reduce the rate of major cardiovascular (CV) events compared with standard therapy in patients with type 2 diabetes (T2D). This publication reports on the extended follow-up of VADT participants over a median of 9.8 years, with data available for 92.4% of patients. The primary outcome was time to the first major CV event; secondary outcomes were CV mortality and all-cause mortality.

Evaluation of Lixisenatide in Acute Coronary Syndrome Study – American Diabetes Association Scientific Sessions

Clinical trial results for the ELIXA study (Evaluation of Lixisenatide in Acute Coronary Syndrome) were presented at the American Diabetes Association 75th Annual Scientific Sessions. This multi-country, multisite study evaluated over 6,000 patients with type 2 diabetes (T2D) who had experienced an acute coronary syndrome event in the 180 days before enrollment.

Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes

Results of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study were simultaneously presented at the American Diabetes Association 75th Annual Scientific Sessions and published online by the New England Journal of Medicine. This randomized, double-blind study evaluated 14,671 patients with type 2 diabetes and established cardiovascular (CV) disease who added sitagliptin or placebo to their existing therapeutic regimen.

Results Presented for the Fluctuation Reduction With Insulin and GLP-1 Added Together (FLAT-SUGAR) Trial

Results of the Fluctuation Reduction With Insulin and Glucagon-like Peptide-1 agonist (GLP-1) Added Together (FLAT-SUGAR) trial were presented at the American Diabetes Association 75th Annual Scientific Sessions. This trial was developed to assess the severity and impact of glucose variability (assessed using masked continuous glucose monitoring [CGM]), on cardiovascular (CV) risk in middle-aged and older patients with type 2 diabetes and additional CV risk factors. The FLAT-SUGAR trial enrolled 102 patients receiving background therapy with basal insulin (glargine) and metformin.

Adding Dapagliflozin to Insulin and Liraglutide Leads to Significant Improvements in Glycemic Control in Patients With Type 1 Diabetes

Results of a retrospective analysis evaluating the impact of triple therapy with insulin, liraglutide, and dapagliflozin in patients with type 1 diabetes were presented at the 24th Annual American Association of Clinical Endocrinologists Scientific and Clinical Congress. This retrospective analysis evaluated the impact of adding dapagliflozin therapy to 10 patients already receiving liraglutide plus insulin. Dapagliflozin was initiated at a daily dose of 5 mg and increased to 10 mg over approximately 1 week; results were evaluated after 12 weeks of triple therapy.

FDA Drug Safety Communication: SGLT2 Inhibitors for Diabetes May Result in Ketoacidosis

The US Food and Drug Administration (FDA) is warning that the sodium-glucose cotransporter-2 (SGLT2) inhibitors canagliflozin, dapagliflozin, and empagliflozin, used to treat type 2 diabetes, may lead to ketoacidosis. Patients should seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Health care professionals should evaluate patients who present with these signs or symptoms and discontinue SGLT2 inhibitors if acidosis is confirmed.

Pages