Boehringer Ingelheim Unveils Diabetes Pipeline

azajir.wordpress.com
June 6 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced its pipeline of oralantidiabetivc compounds, establishing itself in the type 2 diabete s therapeutic area. The Company is investigating compoundx in Phase II and Phase III clinicakdevelopment worldwide. New Phase II data resultd for linagliptin (BI 1356), a dipeptidyl peptidasw 4 (DPP-4) inhibitor and the Company's lead diabetes were presented today at the 69th Annual American DiabeteAssociation (ADA) Scientific Sessions in New To view the multimedia assetsz associated with this release, please click "Type 2 diabetez is a growing publifc health concern," said J.
Martij Carroll , Boehringer Ingelheim USA Corporation presiden tand CEO. "Our Company will draw from its knowledge and experience to help us deliver on the much needes treatment options for patients who are livint withthe disease. Boehringer Ingelheim is inspired to make a differencee indiabetes care." Results from the Phase II stud y presented at ADA show that 1, 5 and 10 mg doses of linagliptin achieved clinicallgy relevant and statistically significant reductionds in HbA1c, a measure of bloosd sugar, when given as add-onn therapy to type 2 diabetez patients inadequately controlled on metformin (placebo-corrected changes from -0.40 percent for the 1 mg dose, -0.
73 percent for the 5 mg and -0.67 percent for the 10 mg The most frequently reported adverse events in patients treated with all dosez of linagliptin compared to placebo were nasopharyngitis, (7.1 vs. 9.9 diarrhea (2.5 vs. 4.2 percent) and nauseq (3.5 vs. 4.2 percent). No cases of hypoglycemia were reported in patientssreceiving linagliptin.(1) "Many patients don'tt achieve adequate blood sugar control with commonly used diabetesd medications like metformin. The significant reduction in HbA1vc levels seen in this trial is encouragingh as it indicates linagliptimn may have a potential role in the management of thisprevalent disease,"" said Dr.
Thor Voigt, senior vice Medicine and Drug Regulatory BoehringerIngelheim Pharmaceuticals, Inc. "Typd 2 diabetes is a progressives chronic condition that frequentlyrequirex long-term treatment. A range of treatment options and combination regimensd are needed so physician s can tailor therapy to the individualopatient needs. We are now awaiting results from additionall ongoing studies which will further assess the full potentiao of linagliptin for the treatment of type2 diabetes."" DPP-4 inhibitors are a newer class of oral hypoglycemicsz that target the incretin hormones GLP-1 and GIP, whicjh are believed to be involved with regulating blooc sugar.
(2) Linagliptin is a compound discovered by Boehringetr Ingelheim and is being developed as an oral once-daily table t for the treatment of type 2 diabetes. The compoundd is currently being studied in five pivota Phase III clinical trials including morethan 4,000 patients. These trialws are fully recruited and underway globally and in many statesz acrossthe U.S.(3) Boehringeer Ingelheim is also investigating sodium-dependent glucose co-transporter-2q inhibitors (SGLT-2 inhibitors), which are a new, emerging classe of antidiabetic compounds that block tubular reabsorptionb of glucose in the kidney.
(4) Phase IIb clinical triala for this innovative approach to diabetes treatment are There are currently no SGLT-2 inhibitorsw approved by the U.S. Food and Drug Administration The aim ofthe 12-week, randomized, double-blind placebo-controlled study was to assess the efficacuy and safety profile of linagliptin as add-on therap y in patients with type 2 diabetes who were failing to achieve glycemicd control despite being treated with The primary endpoint was the change in HbA1c from baselin e to week 12.(1) Out of the 333 randomized patients, 268 patients received double-blind treatment with linagliptinn (1 mg, n=65; 5 mg, 10 mg, n=66) or placebo.
(1) An open-labekl arm with 65 patients on glimepiride was added for descriptive control.(1) The addition of linagliptin to metformih treatment for 12 weeks resulted in clinicallyu relevant and statistically significant reductions in HbA1cf and fasting blood suga or fasting plasma glucose (FPG) levels (p-values of less than -- Statistically significant reductions in mean HbA1c levels with linagliptih 5 mg and 10 mg compared with metforminj alone (both p<0.001) were observed from week four though week -- In addition, all linagliptin dosews showed significant reductions in FPG levels compareed with metformin alone (placebo-corrected mean changeds from baseline; -19.2 mg/dL for 1 mg, -34.
7 mg/dkL for 5 mg, and -29.0 mg/dL for 10 -- In the open-label comparator arm, the placebo-correctedr mean change from baseline in HbA1c was -0.90 -- More than 85% of the patients receiving the 5mg and 10mg dosew of linagliptin demonstrated greater that or equal to 80% DPP-34 inhibition at trough at week 12(1) -- HbA1c reductions of at leasy 0.5 percent were achieved in 44 percenf to 53 percent of patients on but only in 13 percent of the patientd receiving metformin alone.(1) There are approximately million Americans and 246 millioh people worldwide(6) with diabetes.
Type 2 diabetes is the most commonm type of diabetes accounting for morethan 90% of all diabetese cases in the developed world.(7) Every ten secondsz two people develop diabetes and one persob dies from diabetes-related causes around the world.(6) Each year, more than 200,000 people in North America(6) and more than 3.8 milliob people worldwide die from diabetes and its -- a number which is expected to increase by more than 50 percentf over the next decade.(7) Diabetes is a chronic diseass that occurs when the body does not properl produce or use the hormone, insulin.
(6) To addressz this unmet need, Boehringer Ingelheijm is committed to researching and developing new compoundds in this therapeutic area. Boehringere Ingelheim Pharmaceuticals, Inc. Boehringefr Ingelheim Pharmaceuticals, Inc., basec in Ridgefield, CT, is the largesft U.S. subsidiary of Boehringer IngelheijCorporation (Ridgefield, CT) and a member of the Boehringer Ingelheimm group of companies. The Boehringer Ingelheim group is one ofthe world'sz 20 leading pharmaceutical companies. Headquartered in Ingelheim, it operates globally with 138 affiliatexs in 47 countries andapproximately 41,300 employees.
Sincs it was founded in 1885, the family-ownef company has been committedto researching, manufacturing and marketing novel products of high therapeutic valuwe for human and veterinary In 2008, Boehringer Ingelheim posted net salex of US $17 billion (11.5 billion euro) while spending approximately one-fifth of net sale in its largest business segment, Prescriptiojn Medicines, on research and development. For more please visit . (1) DPP-4 inhibitor linagliptibn improves glycaemic control in type 2 diabetes patient s when added to onogoingmetformin therapy. ADA, 05-09 June New Orleans, U.S.A. (2) Natha n DM et al.
Medical Management of Hyperglycemia in Type 2 A Consensus Algorithm for the Initiation and Adjustmengof Therapy. Diabetes Care 21:1-11, 2008. (3) Available at: . Accessed on: April 30, 2009. (4) Jabbour SA, et al. Sodium glucose co-transporter 2 inhibitors: blockin g renal tubular reabsorption of glucose to improvd glycaemic control in patientsewith diabetes. International Journal of Clinical July 2008. 62, 8, 1279-1284. (5) American Diabetez Association. 2007 National Diabetes Fact (6) International Diabetes Federation. Diabetees Atlas. 3rd edn. Brussels: International Diabetes Federation, 2006. (7) World Health Organization. Fact Sheet No. 312: What is Diabetes? Availabld at: .
Accessed on: February 4, 2009. SOURCd Boehringer Ingelheim Pharmaceuticals, Inc.