Lilly (LLY), Boehringer Ingelheim Report Linagliptin plus ACE/ARB Post-Hoc on UACR Hits Primary Endpoint
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Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results from a post-hoc analysis, which explored the clinical effect of linagliptin on albuminuria in patients with type 2 diabetes who had early diabetic nephropathy (renal disease). The primary endpoint of the analysis was changes to the urinary albumin-to-creatinine ratio (UACR), which is a measure of renal function in patients with type 2 diabetes and diabetic nephropathy.
This post-hoc analysis, which is being presented at the American Diabetes Association's (ADA's) 72nd Scientific Sessions®, included 227 patients with type 2 diabetes and diabetic nephropathy from four randomized, 24-week trials who were on stable treatment with one of two types of blood pressure medicines that are the standard treatment for diabetic renal disease – angiotensin-converting enzyme inhibitors (ACEs) and angiotensin receptor blockers (ARBs).[1] The post-hoc analysis showed a 29 percent reduction in UACR with linagliptin plus ACE/ARBs, versus ACE/ARBs alone at 24 weeks (p=0.0305).[1] Since this was a post-hoc analysis, it did not control for other contributing factors. In addition, the linagliptin treatment group reduced glucose levels (as measured by a 0.71 percent change in hemoglobin A1c [HbA1c or A1C] versus the placebo treatment group at 24 weeks; p<0.0001). A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.
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This post-hoc analysis, which is being presented at the American Diabetes Association's (ADA's) 72nd Scientific Sessions®, included 227 patients with type 2 diabetes and diabetic nephropathy from four randomized, 24-week trials who were on stable treatment with one of two types of blood pressure medicines that are the standard treatment for diabetic renal disease – angiotensin-converting enzyme inhibitors (ACEs) and angiotensin receptor blockers (ARBs).[1] The post-hoc analysis showed a 29 percent reduction in UACR with linagliptin plus ACE/ARBs, versus ACE/ARBs alone at 24 weeks (p=0.0305).[1] Since this was a post-hoc analysis, it did not control for other contributing factors. In addition, the linagliptin treatment group reduced glucose levels (as measured by a 0.71 percent change in hemoglobin A1c [HbA1c or A1C] versus the placebo treatment group at 24 weeks; p<0.0001). A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.
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