In The News

Initial Combination of Empagliflozin and Linagliptin in Patients With Type 2 Diabetes

This 52-week randomized study was conducted to evaluate the efficacy and safety of combined therapy with empagliflozin and linagliptin in patients with type 2 diabetes (T2D). Mean baseline patient A1C was approximately 8%. Following a washout period, patients (N=677) were proportionally assigned to 1 of 5 study groups (listed with A1C reductions achieved at 24 weeks): empagliflozin 25 mg/linagliptin 5 mg (-1.08%); empagliflozin 10 mg/linagliptin 5 mg (-1.24%); empagliflozin 25 mg (-0.95%); empagliflozin 10 mg (-0.83%); or linagliptin 5 mg (-0.67%).

Preventable Major Cardiovascular Events Associated With Uncontrolled Glucose, Blood Pressure, and Lipids, and Active Smoking in Adults With Diabetes With and Without Cardiovascular Disease: A Contemporary Analysis

This study assessed the incidence of major cardiovascular (CV) hospitalization events and all-cause deaths among adults with diabetes with or without cardiovascular disease (CVD), inadequately controlled A1C, elevated LDL cholesterol (LDL-C) and blood pressure (BP), and current smoking. Participants were 859,617 adults with diabetes enrolled in U.S. integrated health care organizations between 2005 and 2011 (31% with existing CVD).

FDA Approves New Insulin Product, Toujeo

The U.S. Food and Drug Administration (FDA) has approved insulin Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL). Expected to be available in the United States by mid-2015, this once-daily, long-acting basal insulin has been approved to improve glycemic control in adults with type 1 and type 2 diabetes. This approval was based on FDA review of results from the EDITION clinical trial program, a series of international phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults with diabetes.

A Randomized Controlled Trial to Provide Adherence Information and Motivational Interviewing to Improve Diabetes and Lipid Control

This study assessed whether patients with medication adherence information (AI) provided to their physicians, with or without motivational interviewing (MI), was associated with improved diabetes and lipid control. Participants (N=1692) were members of a single large Michigan health system; they had A1C levels above target and were receiving oral antidiabetic and lipid-lowering medications. Patients were assigned to usual care (UC) or UC with AI or with AI + MI. The primary outcomes were A1C and LDL cholesterol levels at 18 months.

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

This study was designed to evaluate the impact of patient gender on glucose control and hypoglycemia incidence in insulin-naïve patients with inadequately controlled type 2 diabetes (T2D). Investigators evaluated patient-level pooled data from 6 randomized controlled trials of insulin glargine or NPH insulin (N=2600; trials were 24-36 weeks duration). Mean baseline patient A1C was ~8.9%-9.0% and mean patient age was 57 years.

FDA Approves Lucentis to Treat Diabetic Retinopathy in Patients With Diabetic Macular Edema

The U.S. Food and Drug Administration (FDA) has expanded the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy in patients with diabetic macular edema. This treatment is administered by a physician monthly via injection into the eye. You can read the full FDA press release here.

FDA Approves Empagliflozin/Linagliptin Combination for Adults With Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) has approved combined empagliflozin/linagliptin tablets (Glyxambi®) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are good candidates for both drugs. The once-daily tablet combines a sodium-glucose cotransporter 2 (SGLT2) inhibitor (empagliflozin, 10 or 25 mg) with a dipeptidyl peptidase-4 (DPP-4) inhibitor (linagliptin, 5 mg).

Incretin-Based Drugs and the Risk of Congestive Heart Failure

This retrospective analysis was conducted to determine whether the use of incretin-based drugs (dipeptidyl-peptidase-4 inhibitors, glucagon-like receptor-1 analogs) was associated with an increased risk of congestive heart failure (CHF) among patients with type 2 diabetes. Data were obtained from the UK Clinical Practice Research Datalink, and patients with no prior CHF history and newly prescribed to antidiabetic drug regimens between January 1, 2007, and March 31, 2012, were evaluated. The cohort comprised 57,737 patients, with a mean 2.4 years’ follow-up.

Initial Combination Treatment With Empagliflozin and Linagliptin in Patients With Type 2 Diabetes

January 29, 2015. This study randomized antihyperglycemic drug-naïve patients (N=677) with type 2 diabetes to 52 weeks of treatment with 1 of 5 regimens: empagliflozin (EMP) 25 mg + linagliptin (LIN) 5 mg; EMP 10 mg + LIN 5 mg; EMP 25 mg; EMP 10 mg; or LIN 5 mg.  The primary endpoint was change in A1C from baseline to week 24; patients’ mean baseline A1C levels were 7.99% to 8.05%.

Incretin-Based Therapy and Risk of Acute Pancreatitis: A Nationwide Population-Based Case-Control Study

January 29, 2015. This case control study evaluated whether the use of incretin-based drug therapy (glucagon-like peptide-1 agonists and dipeptidyl peptidase-4 inhibitors) in type 2 diabetes was associated with an elevated risk of acute pancreatitis. Data were obtained from a nationwide population-based Danish medical database (12,868 patients with a first-time hospitalization for acute pancreatitis between 2005 and 2012, and 128,680 matched controls).