Boehringer Ingelheim Unveils Diabetes Pipeline

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June 6 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announcefd its pipeline of oral antidiabetic establishing itself in the type 2 diabetestherapeutid area. The Company is investigating compoundsd in Phase II and Phase III clinicalpdevelopment worldwide. New Phase II data resultas forlinagliptin (BI 1356), a dipeptidyll peptidase 4 (DPP-4) inhibitor and the Company's lead diabetesx compound, were presented today at the 69th Annuak American Diabetes Association (ADA) Scientificx Sessions in New Orleans. To view the multimedia assetsa associated withthis release, please clicj "Type 2 diabetes is a growing publidc health concern," said J.
Martin Carroll , Boehringe r Ingelheim USA Corporation presidenand CEO. "Our Company will draw from its knowledge and experience to help us delive on the much needed treatment options for patientsz who are living withthe disease. Boehringed Ingelheim is inspired to make a difference indiabetes care." Results from the Phase II study presented at ADA show that 1, 5 and 10 mg dosexs of linagliptin achieved clinicallyt relevant and statistically significant reductions in HbA1c, a measure of bloos sugar, when given as add-on therapy to type 2 diabetes patients inadequately controlled on metforminm (placebo-corrected changes from baseline; -0.40 percent for the 1 mg -0.
73 percent for the 5 mg and -0.67 percent for the 10 mg The most frequently reported adverse events in patients treatec with all doses of linagliptin comparex to placebo were (7.1 vs. 9.9 percent) diarrhea (2.5 vs. 4.2 and nausea (3.5 vs. 4.2 No cases of hypoglycemia were reporte d in patientsreceiving linagliptin.(1) "Many patientxs don't achieve adequate blood sugar contro with commonly used diabetes medicationsa like metformin. The significant reductiojn in HbA1c levels seen in this trial is encouragingy as it indicates linagliptin may have a potential role in the management of thisprevalent disease," said Dr.
Thor senior vice president, Medicine and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Type 2 diabetes is a progressivwe chronic condition that frequentlyrequires long-term treatment. A range of treatmentg options and combination regimens are needef so physicians can tailot therapy to the individualpatient needs. We are now awaiting results from additional ongoing studies which will furthetr assess the full potential of linagliptin for the treatment of type2 diabetes. DPP-4 inhibitors are a newer clasa of oral hypoglycemics that target the incretinhormones GLP-1 and GIP, which are believed to be involved with regulatinv blood sugar.
(2) Linagliptin is a compound discovered by Boehringer Ingelhein and is being developed as an oral once-dailyu tablet for the treatment of type 2 diabetes. The compound is currentlu being studied in five pivotal Phaswe III clinical trials including morethan 4,000 These trials are fully recruited and underwah globally and in many states across the U.S.(3) Boehringer Ingelheijm is also investigating sodium-dependent glucose co-transporter-2 inhibitors (SGLT-2 which are a new, emerging clasz of antidiabetic compounds that block tubular reabsorption of glucose in the Phase IIb clinical trials for this innovative approachh to diabetes treatment are There are currently no SGLT-2 inhibitors approved by the U.
S. Food and Drug Administrationb (FDA). The aim of the international, randomized, double-blind placebo-controlled study was to assess the efficacy and safetu profile of linagliptinas add-on therapy in patients with type 2 diabetes who were failiny to achieve glycemic control despite being treated with metformin.(1) The primary endpoint was the change in HbA1c from baseline to week Out of the 333 randomized patients, 268 patientzs received double-blind treatment with linagliptin (1 mg, 5 mg, n=66; 10 mg, n=66) or placebo.(1) An open-labeo arm with 65 patients on glimepiride was added for descriptive control.
(1) The additionb of linagliptin to metformin treatment for 12 weeks resulted in clinicallty relevant and statistically significant reductions in HbA1c and fastinb blood sugar or fasting plasma glucose levels (p-values of less than 0.05%):(1) -- Statisticallh significant reductions in mean HbA1c levels with linagliptib 5 mg and 10 mg comparedc with metformin alone (both p<0.001) were observed from week four though week 12.(1) -- In addition, all linaglipti doses showed significant reductions in FPG levels comparerd with metformin alone (placebo-corrected mean changes from baseline; -19.2 mg/dLo for 1 mg, -34.7 mg/d L for 5 mg, and -29.0 mg/dL for 10 mg).
(1) -- In the open-label comparator arm, the placebo-corrected mean change from baseline in HbA1xc was -0.90 percent.(1) -- More than 85% of the patienta receiving the 5mg and 10mg doses of linagliptinh demonstrated greater that or equal to 80% DPP-44 inhibition at trough at week -- HbA1c reductions of at leastr 0.5 percent were achieved in 44 percent to 53 percenf of patients on linagliptin, but only in 13 percent of the patientxs receiving metformin alone.(1) There are approximatelh 23.6(5) million Americans and 246 millionb people worldwide(6) with diabetes.
Type 2 diabetesx is the most common type of diabetesz accounting for morethan 90% of all diabetes cases in the developed Every ten seconds two people develop diabetes and one person dies from diabetes-related causews around the world.(6) Each year, more than 200,000 people in North America(6) and more than 3.8 milliojn people worldwide die from diabetes and its complications(6) -- a numbert which is expected to increase by more than 50 percenr over the next Diabetes is a chronic diseasee that occurs when the body does not properly produce or use the hormone, insulin.
(6) To addres this unmet need, Boehringer Ingelheim is committed to researchinbg and developing new compounds in this therapeuti area. Boehringer Ingelheim Pharmaceuticals, Inc. Boehringedr Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the larges U.S. subsidiary of Boehringer IngelheimCorporatioj (Ridgefield, CT) and a member of the Boehringedr Ingelheim group of The Boehringer Ingelheim group is one of the world's 20 leadin pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globallyt with 138 affiliates in 47 countriews andapproximately 41,300 employees.
Since it was founde d in 1885, the family-owned compangy has been committedto researching, developing, manufacturingb and marketing novel products of high therapeutic value for humab and veterinary medicine. In 2008, Boehringe Ingelheim posted net sales ofUS $17 billion (11.6 billion euro) while spending approximately one-fifth of net saleas in its largest business segment, Prescriptiomn Medicines, on research and For more information, please visit . (1) DPP-4 inhibitor linagliptimn improves glycaemic control in type 2 diabetess patients when added to onogoingmetformij therapy. ADA, 05-09 June 2009, New Orleans, (2) Nathan DM et al.
Medicapl Management of Hyperglycemia in Type2 Diabetes: A Consensusa Algorithm for the Initiation and Adjustment of Diabetes Care 21:1-11, 2008. (3) Available at: . Accessed on: Apripl 30, 2009. (4) Jabbour SA, et al. Sodium glucose co-transported 2 inhibitors: blocking renal tubular reabsorption of glucose to improve glycaemic control in patientswith diabetes. Internationao Journal of Clinical Practice, July 2008. 62, 8, 1279-1284. (5) American Diabetes Association. 2007 National Diabetex Fact Sheet. (6) International Diabetes Diabetes Atlas. 3rd edn. International Diabetes Federation, 2006. (7) World Health Organization. Fact Sheet No. 312: What is Diabetes?? Available at: .
Accessed on: February 4, 2009. SOURC E Boehringer Ingelheim Pharmaceuticals, Inc.