Boehringer Ingelheim Unveils Diabetes Pipeline

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June 6 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. todah announced its pipeline of oralantidiabetic compounds, establishing itselfd in the type 2 diabetes therapeuticx area. The Company is investigating compounde in Phase II and Phase III clinicaldevelopmentf worldwide. New Phase II data resultws forlinagliptin (BI 1356), a dipeptidyl peptidase 4 inhibitor and the Company's lead diabetew compound, were presented today at the 69th Annual America Diabetes Association (ADA) Scientific Sessions in New Orleans. To view the multimediaa assets associated with this pleaseclick "Type 2 diabetes is a growing publifc health concern," said J.
Martin Carroll , Boehringerf Ingelheim USA Corporation presidentand CEO. "Our Company will draw from its knowledg and experience to help us deliver on the much neederd treatment options for patients who are living withthe disease. Boehringee Ingelheim is inspired to make a difference indiabetes care." Results from the Phass II study presented at ADA show that 1, 5 and 10 mg doseas of linagliptin achieved clinically relevant and statisticallty significant reductions in HbA1c, a measure of blood when given as add-on therapy to type 2 diabetes patients inadequately controlled on metformibn (placebo-corrected changes from baseline; -0.40 percent for the 1 mg dose, -0.
73 percen t for the 5 mg and -0.67 percent for the 10 mg The most frequently reported adverser events in patients treated with all doses of linagliptin compared to placeboo were nasopharyngitis, (7.1 vs. 9.9 percent) diarrheqa (2.5 vs. 4.2 percent) and nausea (3.5 vs. 4.2 No cases of hypoglycemia were reported in patientsreceivingh linagliptin.(1) "Many patients don't achieve adequates blood sugar control with commonly used diabetes medications like The significant reduction in HbA1c levels seen in this trial is encouraging as it indicates linagliptin may have a potentialo role in the management of this prevalenyt disease," said Dr.
Thor senior vice president, Medicine and Drug Regulatoryt Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Type 2 diabetews is a progressive chronic condition that frequentlgyrequires long-term treatment. A range of treatmenrt options and combination regimens are needed so physicians can tailofr therapy to the individualpatient needs. We are now awaitinyg results from additional ongoing studies which will further assess the full potential of linagliptin for the treatmentf of type2 diabetes." DPP-4 inhibitorzs are a newer class of oral hypoglycemicsd that target the incretin hormonea GLP-1 and GIP, whicgh are believed to be involved with regulatinb blood sugar.
(2) Linagliptin is a compounds discovered by Boehringer Ingelheim and is bein developed as an oral once-daily tablet for the treatment of type 2 The compound is currently being studied in five pivotalp Phase III clinical trials including more than 4,000o patients. These trials are fully recruited and underwayu globally and in many states across the Boehringer Ingelheim is alsoinvestigating sodium-dependenr glucose co-transporter-2 inhibitors (SGLT-2 which are a new, emerging clasz of antidiabetic compounds that blockl tubular reabsorption of glucose in the Phase IIb clinical trials for this innovativse approach to diabetes treatment are underway.
There are currentlg no SGLT-2 inhibitors approved by the U.S. Food and Drug Administration The aim ofthe international, randomized, double-blind placebo-controlled study was to assess the efficacyu and safety profile of linagliptin as add-on therapuy in patients with type 2 diabetes who were failingg to achieve glycemic control despiter being treated with metformin.(1) The primary endpoint was the change in HbA1c from baseline to week Out of the 333 randomized patients, 268 patients receivedf double-blind treatment with linagliptinh (1 mg, n=65; 5 mg, n=66; 10 mg, or placebo.(1) An open-label arm with 65 patients on glimepiridre was added for descriptive control.
(1) The additionm of linagliptin to metformin treatment for 12 weekas resulted in clinically relevant and statisticall y significant reductions in HbA1v and fasting blood sugar or fasting plasmaq glucose (FPG) levels (p-values of less than -- Statistically significant reductions in mean HbA1cv levels with linagliptin 5 mg and 10 mg compared with metformin alone (both p<0.001) were observed from week four though week 12.(1) -- In addition, all linagliptin dosew showed significant reductions in FPG levelxs compared with metformin alone (placebo-corrected mean changez from baseline; -19.2 mg/dL for 1 mg, -34.7 mg/do for 5 mg, and -29.0 mg/dpL for 10 mg).
(1) -- In the open-label comparator arm, the placebo-corrected mean changd from baseline in HbA1c was -0.90 -- More than 85% of the patientzs receiving the 5mg and 10mg doses of linagliptinh demonstrated greater that or equal to 80% DPP-4 inhibitio at trough at week 12(1) -- HbA1cf reductions of at leasft 0.5 percent were achieved in 44 percent to 53 percent of patients on linagliptin, but only in 13 percen t of the patients receiving metforminb alone.(1) There are approximately 23.6(5) million Americane and 246 million people worldwide(6) with diabetes.
Type 2 diabetezs is the most common type of diabetes accountintg for morethan 90% of all diabetesa cases in the developed Every ten seconds two peoplde develop diabetes and one person dies from diabetes-relatesd causes around the world.(6) Each year, more than 200,00 0 people in North America(6) and more than 3.8 milliom people worldwide die from diabetes and its complications(6) -- a numbeer which is expected to increase by more than 50 percentt over the next Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone, To address this unmet Boehringer Ingelheim is committed to researching and developing new compounds in this therapeutic Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringerd Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiarty of Boehringer IngelheimCorporation CT) and a member of the Boehringer Ingelheim groul of companies. The Boehringer Ingelheim group is one ofthe world'e 20 leading pharmaceutical Headquartered in Ingelheim, Germany, it operates globallg with 138 affiliates in 47 countries and approximatelyu 41,300 employees. Since it was foundedx in 1885, the family-owned company has been committe dto researching, developing, manufacturing and marketinvg novel products of high therapeutic value for human and veterinary medicine. In 2008, Boehringe Ingelheim posted net sales ofUS $17 billion (11.
6 billioj euro) while spending approximately one-fiftb of net sales in its largest businesws segment, Prescription Medicines, on researchj and development. For more information, please visit . (1) DPP-4 inhibitor linagliptij improves glycaemic control in type 2 diabetes patientss when added to onogoingmetformin ADA, 05-09 June New Orleans, U.S.A. (2) Nathan DM et al. Medicakl Management of Hyperglycemia in Type2 Diabetes: A Consensua Algorithm for the Initiation and Adjustmenyt of Therapy. Diabetes Care 21:1-11, 2008. (3) Available at: . Accessed on: April 30, 2009. (4) Jabbouer SA, et al.
Sodium glucosd co-transporter 2 inhibitors: blocking renal tubular reabsorption of glucose to improved glycaemic control in patientswith diabetes. International Journal of Clinical Practice, July 2008. 62, 8, (5) American Diabetes Association. 2007 Nationa Diabetes Fact Sheet. (6) International Diabetes Federation. Diabetes 3rd edn. Brussels: International Diabetes Federation, 2006. (7) Worl d Health Organization. Fact Sheet No. 312: What is Diabetes?? Available at: . Accessed on: Februarty 4, 2009. SOURCE Boehringer Ingelheim Inc.