Boehringer Ingelheim announces results of phase III data showing that linagliptin significantly lowered blood glucose with an excellent safety and tolerability profile

General Press Releases Friday July 23, 2010 09:28
Bangkok--23 Jul--PR & Associates
New phase III data demonstrate clinically meaningful improvements in blood glucose control with linagliptin mono- and combination therapy

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

Diabetes is a common and growing problem in Thailand, as it is throughout the developing world, particularly for those over the age of 35. A recent study, supported by the Health Systems Research Institute, Thailand and the Endocrine Society of Thailand found that the estimated national prevalence of diabetes in Thai adults is 9.6 percent, which includes 4.8 percent previously diagnosed and 4.8% newly diagnosed diabetes. However, the Ministry of Public Health estimates that nearly 30 percent of sufferers are not receiving treatment because they are unaware that they have the disease.

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 placebo1 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 diabetes.10

In a further study, linagliptin monotherapy showed superiority in glucose lowering versus placebo and versus voglibose, the most commonly used alpha glucosidase inhibitor in Japan.5-6
Notes to Editor:
About Diabetes and Type 2 Diabetes

There are approximately 285 million people with diabetes in the adult population worldwide.11 The International Diabetes Federation estimates that the number of people with diabetes will increase to 438 million people worldwide by 2030. Nearly four million people within the 20-79 age group are predicted to die from diabetes and its complications in 2010.11 Approximately 50% of people with diabetes die of cardiovascular disease,11 and more than 8% die of renal causes.12

About Diabetes is Asia:
Prevalence of diabetes according to the
World Health Organization13
Country 2000 2030
China (incl Taiwan and Hong Kong) 20,757,000 42,321,000
Singapore 328,000 695,000
Malaysia 942,000 2,479,000
Indonesia 8,426,000 21,257,000
Thailand 1,536,000 2,739,000
Philippines 2,770,000 7,798,000
Vietnam 792,000 2,343,000
For more information about type 2 diabetes, please also visit:
Media webcast hosted by Boehringer Ingelheim at http://www.boehringer-ingelheim-webcast.com/diabetes
Diabetes Health Lounge website at http://www.DiabetesHealthLounge.com
DPP-4 mode of action video at http://www.youtube.com/user/diabetesmatters
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies.

Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.
For more information please visit www.boehringer-ingelheim.com
Contact:
Kate McLennan
Edelman
Phone: + 65 6347 2307
E-mail: kmclennan@edelman.com

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