In The News

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.

Asian Indians Show High Incidence of Diabetes and Rapid Progression

This article evaluated the incidence of diabetes and prediabetes and the rates and predictors of dysglycemic progression in a population-based Asian Indian cohort (the Chennai Rural Epidemiology Study). At baseline, diabetes, prediabetes, and “any dysglycemia” incidence were 22.2, 29.5, and 51.7 per 1,000 person-years, respectively. Over a median 9.1 years of follow-up, 19.4% of individuals with normal glucose tolerance converted to diabetes and 25.7% to prediabetes. Among individuals with baseline prediabetes, 58.9% converted to diabetes.

Effect of the Threshold Suspend Feature for Insulin Delivery on Hypoglycemia

This study evaluated sensor glucose (SG) data from 20,973 patients who enabled the automatic threshold suspend (TS) feature of the MiniMed 530G system and uploaded their pump and sensor data. When enabled, TS suspends insulin delivery for up to 2 hours when SG values reach a prespecified threshold. A comparison was made based on patient-days where TS was enabled (n=758,382) vs not enabled (166,791).

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.