J&J's Janssen Reports Data Demonstrates Adults with Type 2 Diabetes Achieved Blood Glucose Treatment Goals with Use of INVOKANA

Janssen Pharmaceuticals, Inc. (Janssen) today announced results from three real-world analyses, which found significant improvements in blood glucose (A1C) in adults with type 2 diabetes after using the once-daily oral medication INVOKANA® (canagliflozin). In addition, when prescribed for patients already taking multiple blood-glucose-lowering medications, the data found INVOKANA® is associated with further improved A1C control, even when some patients stopped using other blood-glucose-lowering medications. The results presented today are among a total of 15 presentations related to INVOKANA® made at the 20th Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Philadelphia, held May 16 to 20. "These data show INVOKANA® provides significant reductions in A1C in people with type 2 diabetes seen in everyday clinical practice, including patients with more advanced disease than many of our clinical trial participants," said Robert Bailey, M.D., Director, Health Economics and Outcomes Research, Janssen Scientific Affairs. "The findings from these analyses, representing diverse patient types, are generally consistent with those from our Phase 3 clinical development program, and may illustrate how INVOKANA® is performing in real-world settings." A1C, or hemoglobin A1C, is a measure of average blood glucose over the past two to three months. The American Diabetes Association recommends most adults with type 2 diabetes maintain A1C levels of 7 percent or less. Medicare and many health plans use an A1C level of less than 8 percent as a treatment goal.1 Studies have shown that every percentage point drop in A1C levels can reduce the risk of diabetes complications by 40 percent.2 However, nearly half of all adults with type 2 diabetes do not achieve recommended levels of blood glucose control. INVOKANA® is used along with diet and exercise to lower blood glucose in adults with type 2 diabetes. It is the first in a new class of medications called sodium glucose cotransporter 2 (SGLT2) inhibitors available in the United States. The Presentations Glycated Hemoglobin Control in Patients With Type 2 Diabetes Mellitus Treated With Canagliflozin In A Real-World Setting (Abstract 39834, Poster PDB27): Patrick Lefebvre, MA, from Groupe d'analyse, Ltee in Montreal, Canada, presented a retrospective observational study based on 16,163 adults with type 2 diabetes who had been taking INVOKANA® (100 mg or 300 mg daily). Prior to starting on INVOKANA®, the patients had been taking an average of 2.7 anti-hyperglycemic agents (AHAs) to control their blood glucose. INVOKANA® was associated with statistically significant increases in the percent of patients who reached A1C goals. Among patients with a baseline A1C of 7 percent or more, 21.2 percent attained an A1C of less than 7 percent at the earliest assessment (three months). In total, 59.5 percent achieved an A1C of less than 8 percent at three months. The proportion of patients achieving these A1C goals remained stable at six, nine and 12 months. The mean baseline A1C among patients with a baseline A1C above 7 percent was approximately 8.8 percent; mean A1C decreased to 8.0 percent after three months and also remained stable (P < 0.0001 vs. baseline at each time point). Additionally, among patients with systolic / diastolic blood pressure (SBP / DBP) of at least 140/90 mmHg at baseline, 60.0 percent and 75.6 percent achieved blood pressure reduction goals of SBP less than 140 mmHg and DBP less than 90 mmHg, respectively, after three months. The proportions of patients attaining BP control were similar after six, nine and 12 months. The analysis utilized the Cegedim Strategic Data US electronic medical records database, in which 60 percent of contributors are primary care providers. Real-World Treatment Patterns of Antihyperglycemic Agents among Patients with Type 2 Diabetes Mellitus Initiated On Canagliflozin (Abstract 39833, Poster PDB16): Wing Chow, PharmD, MPH, from Janssen Scientific Affairs, presented a retrospective cohort study assessing 4,017 people with type 2 diabetes who had been taking INVOKANA® (100 mg or 300 mg daily). The study found the proportion of patients with A1C less than 8 percent increased from 39 percent at baseline to 66 percent at follow up. Similarly, the proportion with A1C less than 7 percent increased from 13 percent to 28 percent. INVOKANA® was associated with an average A1C reduction from 8.6 percent at baseline to 7.8 percent at follow up. Additionally, of the 80 percent of patients who were using INVOKANA® in combination with other AHAs, 20 percent discontinued at least one AHA during the follow-up period. A total of 826 patients had A1C assessments at baseline, before starting INVOKANA®, and after an average of 112 days after use of INVOKANA®. The study was based on the Optum Research Database, a large U.S. health plan for commercial and Medicare Advantage enrollees. Real-World Canagliflozin Utilization: Impact on Glycemic Control in Patients with Type 2 Diabetes Mellitus (Abstract 39881, Poster PDB13): Lisa Meckley, PhD, Trinity Partners, Waltham, Massachusetts, presented a retrospective cohort study based on 268 adults with type 2 diabetes included in the 2013 Inovalon MORE2 Registry, which consists of commercial, managed Medicare and Medicaid medical claims, pharmacy claims and laboratory data. After an average of 120 days of taking INVOKANA®, the proportion of patients with A1C less than 8 percent increased from 26 percent at baseline to 38 percent. The proportion with A1C less than 7 percent increased from 15 percent to 31 percent. INVOKANA® provided a statistically significant reduction in A1C levels from 8.3 percent to 7.6 percent (P < 0.001). For more details about these studies, visit the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting online, search for abstracts on "diabetes" and with "canagliflozin" in the title, and see presentations PDB13, PDB16 and PDB27.