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Boehringer Ingelheim and Eli Lilly and Company announced Phase III study results for linagliptin (proposed trade name Trajenta® in Europe), demonstrating improved glycaemic control in adults with type 2 diabetes (T2D) whose blood glucose is not adequately maintained. In a two-year study evaluating linagliptin or glimepiride when added to metformin, linagliptin was as effective at lowering blood glucose as glimepiride, as measured by haemoglobin A1C, reduced incidence of hypoglycaemia and fewer cardiovascular (CV) events. Results will be presented at the 71st Annual American Diabetes Association (ADA) Scientific Sessions in San Diego, 24th to 28th June.
“The combination of linagliptin plus metformin provides meaningful glucose control comparable to that of a combination of a sulphonylurea plus metformin. The added benefit is that, unlike a sulphonylurea, linagliptin is not associated with weight gain and does not per se increase the occurrence of hypoglycaemia” said Prof. KlausDugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “In addition, compared to the sulphonylurea glimepiride, linagliptin was associated with a 54 percent relative risk reduction for cardiovascular events in this study. This highlights the promising cardiovascular safety data seen with linagliptin to date which we are currently further exploring in the CAROLINA study.”
“Renal impairment is frequently associated with type 2 diabetes, and is a major factor in limiting the choice of glucose-lowering agents,” said Mark Cooper, MD, deputy director and chief scientific officer, Baker IDI Heart and Diabetes Institute, Australia. “In this trial, linagliptin was effective at lowering A1C, even in patients with poor glycaemic control and renal impairment.”