Updated on 11 June 2012
The results are out - Boehringer and Eli Lilly linagliptin analysis
Singapore: Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company revealed 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.
The post-hoc analysis 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). The analysis showed a 29 percent reduction in UACR with linagliptin plus ACE/ARBs, versus ACE/ARBs alone at 24 weeks (p=0.0305).
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.
Dr John Smith, senior vice president, clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, said that, "As these results are based on a post-hoc analysis, this interesting observation warrants further investigation."