INDIANAPOLIS (dpa-AFX) - Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co. (LLY) 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 or renal disease.
The company stated that 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.
The 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 or ACEs and angiotensin receptor blockers (ARBs).
The company noted that 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). 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.
Linagliptin is marketed as Tradjenta 5mg tablets in the U.S.
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