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New phase III data demonstrate clinically meaningful improvements in blood glucose control with linagliptin mono- and combination therapy HONG KONG, 5 July 2010 -- /PRNewswire-Asia/ -- At the 70th Scientific Sessions of the American Diabetes Association (ADA), phase III data was presented showing that an investigational compound, a dipeptidyl peptidase (DPP)-4 inhibitor, achieved significant, sustained and clinically meaningful reductions in blood glucose as measured by the diabetes triad -- haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and postprandial glucose (PPG) concentrations.(1-6) Linagliptin is being investigated by Boehringer Ingelheim as a once-daily oral treatment in type 2 diabetes. Once considered a disease of the West, type-2 diabetes is an increasing epidemic in Asia, affecting a disproportionately high number of young to middle-aged adults. Within the next 15 years, it is anticipated there will be 380 million people around the world with diabetes—60 percent of which will reside in Asia.(7) Diabetes, and particularly un-controlled diabetes is associated with an increase risk of cardiovascular disease.(11) In the pivotal phase III studies, which included more than 1,000 patients from across Asia, linagliptin was shown to have a very favourable safety profile, with an overall rate of adverse events similar to placebo. In addition, linagliptin showed an excellent tolerability, was weight neutral, showed no increased risk of drug-drug interactions and, importantly, there was no increased risk of hypoglycaemia attributed to linagliptin use in monotherapy, or combination therapy with metformin or pioglitazone.(1-6) “Many type 2 diabetes patients treated with traditional anti-diabetes agents fail to achieve their glycaemic targets to maintain them over time. “This, in addition to the increased risk of hypoglycaemia seen with some traditional diabetes treatments, can leave patients at a higher likelihood of developing diabetes complications, including renal disease, a complication which affects the large majority of type 2 diabetes patients,” said Professor Julio Rosenstock, Clinical Professor of Medicine, University of Texas Southwestern Medical School, Dallas, Texas, USA. Notably, in diabetes patients with mild and moderate renal impairment, linagliptin blood plasma levels were comparable to those seen in diabetes patients with normal renal function,(1) suggesting that linagliptin, which has a primarily non-renal route of excretion, may have distinct pharmacological features not yet seen in this novel class of drugs.(8) The data suggests that linagliptin would not need dose adjustment in patients with type 2 diabetes, regardless of the stage of renal impairment. “Although renal impairment is very common in patients with type 2 diabetes, early stage renal dysfunction often goes undiagnosed, exposing these patients to suboptimal treatment. “For linagliptin, we see from studies that only five percent of the orally administered drug is excreted via the kidneys. Data to date indicate that linagliptin would not require dose adjustment, which could translate into an important benefit for physicians when choosing a treatment, not only for the type 2 diabetes patient population with diagnosed renal impairment, but also for those patients at risk of developing renal complications,” Professor Rosenstock concluded. The incidence of diabetic kidney disease is increasing in the developing world with Asia Pacific being the most severely affected,(9) so it’s important that research and development efforts are focused on options suitable for this growing group of patients. In four multi-centre, 24 weeks, randomised, double-blind, controlled trials, statistically significant reductions in blood glucose were observed with linagliptin monotherapy versus placebo(1) and when used in combination with other commonly used oral anti-diabetes drugs.(2-4) This was accompanied by significant improvements in beta-cell function.(1,3) Declining beta-cell function is a key factor driving the progression of type 2 SOURCE Boehringer Ingelheim About : M140o93H7pQ09L8X1t49cHY01Z5j4TT91fGfr Media Contacts: M140o93H7pQ09L8X1t49cHY01Z5j4TT91fGfr Footnotes: M140o93H7pQ09L8X1t49cHY01Z5j4TT91fGfr Note To Editors: M140o93H7pQ09L8X1t49cHY01Z5j4TT91fGfr Disclaimer: M140o93H7pQ09L8X1t49cHY01Z5j4TT91fGfr Submitted by PR Newswire Asia, Xinhua PR Newswire on Monday, 5 July 2010 at 5:12 PM Category: |
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