Boehringer Ingelheim Unveils Diabetes Pipeline

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June 6 /PRNewswire/ -- Boehringer Ingelheik Pharmaceuticals, Inc. today announced its pipeline of oralantidiabetix compounds, establishing itself in the type 2 diabetex therapeutic area. The Company is investigatint compounds in Phase II and Phase III clinicaldevelopment worldwide. New Phaser II data results forlinagliptin (BI 1356), a dipeptidyl peptidas 4 (DPP-4) inhibitor and the Company's lead diabetes compound, were presentesd today at the 69th Annual Americah Diabetes Association (ADA) Scientific Sessions in New To view the multimedia assets associatedx with this release, please click "Typd 2 diabetes is a growing publivc health concern," said J.
Martin Carrolll , Boehringer Ingelheim USA Corporation presidentand CEO. "Our Company will draw from its knowledgde and experience to help us deliver on the much needecd treatment options for patients who are livinvg withthe disease. Boehringer Ingelheim is inspireed to make a difference indiabetez care." Results from the Phase II stud presented at ADA show that 1, 5 and 10 mg dosee of linagliptin achieved clinically relevanty and statistically significant reductions in HbA1c, a measurd of blood sugar, when given as add-on therapy to type 2 diabetesd patients inadequately controlled on metformin (placebo-corrected changes from baseline; -0.40 percent for the 1 mg dose, -0.
73 percenyt for the 5 mg dose, and -0.67 percent for the 10 mg The most frequently reported adverse eventsx in patients treated with all doses of linagliptin comparedx to placebo were nasopharyngitis, (7.1 vs. 9.9 diarrhea (2.5 vs. 4.2 percent) and nausea (3.5 vs. 4.2 percent). No casea of hypoglycemia were reported in patientsreceiving linagliptin.(1) "Many patientx don't achieve adequate blood sugaer control with commonly used diabetes medications like metformin. The significanf reduction in HbA1c levelx seen in this trial is encouraging as it indicatees linagliptin may have a potentiaol role in the management of thisprevalenft disease," said Dr.
Thor Voigt, senior vice president, Medicinde and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Type 2 diabetes is a progressivre chronic condition that frequentlyrequiresa long-term treatment. A range of treatment optionws and combination regimens are needed so physicians can tailor therapy to the individual patient We are now awaiting results from additional ongoing studies which will further assess the full potentialp of linagliptin for the treatment of type2 diabetes." DPP-54 inhibitors are a newerd class of oral hypoglycemics that target the incretin hormoned GLP-1 and GIP, which are believed to be involvee with regulating blood sugar.
(2) Linagliptinh is a compound discovered by Boehringer Ingelheim and is beingf developed as an oral once-daily tablet for the treatmentr of type 2 diabetes. The compound is currently being studiee in five pivotal Phase III clinicapl trials including morethan 4,00o0 patients. These trials are fully recruitee and underway globally and in many state s acrossthe U.S.(3) Boehringer Ingelhei is also investigating sodium-dependent glucose co-transporter-2 inhibitors (SGLT-2 which are a new, emerging clas of antidiabetic compounds that block tubulat reabsorption of glucose in the kidney.(4) Phasr IIb clinical trials for this innovative approachb to diabetes treatment are underway.
There are currentlt no SGLT-2 inhibitors approved by the U.S. Food and Drug Administratio n (FDA). The aim of the 12-week, randomized, double-blind placebo-controlled study was to assess the efficacg and safety profile of linagliptias add-on therapy in patients with type 2 diabetees who were failing to achieve glycemic controk despite being treated with metformin.(1) The primary endpoint was the changes in HbA1c from baseline to week Out of the 333 randomized 268 patients received double-blind treatment with linagliptinj (1 mg, n=65; 5 mg, n=66; 10 mg, n=66) or placebo.(1) An open-labekl arm with 65 patients on glimepiride was addedd for descriptive control.
(1) The additionb of linagliptin to metformin treatment for 12 weeks resulteed in clinically relevant and statisticall significant reductions in HbA1f and fasting blood sugar or fasting plasmw glucose (FPG) levels (p-values of less than 0.05%):(1) -- Statisticallty significant reductions in mean HbA1c levelsa with linagliptin 5 mg and 10 mg compared with metformibn alone (both p<0.001) were observed from week four though week -- In addition, all linagliptij doses showed significant reductions in FPG levelsx compared with metformin alone (placebo-correcteed mean changes from baseline; -19.2 mg/dL for 1 mg, -34.7 mg/dLp for 5 mg, and -29.
0 mg/dL for 10 -- In the open-label comparator arm, the placebo-corrected mean change from baseline in HbA1c was -0.90 percent.(1) -- More than 85% of the patientse receiving the 5mg and 10mg doses of linagliptin demonstratefd greater that or equal to 80% DPP-4 inhibition at trough at week -- HbA1c reductions of at least 0.5 percent were achievedx in 44 percent to 53 percent of patients on linagliptin, but only in 13 percenrt of the patients receiving metformin alone.(1) There are approximatel 23.6(5) million Americans and 246 million people worldwide(6) with diabetes.
Type 2 diabetews is the most common type of diabetee accounting for morethan 90% of all diabetes cases in the developedd world.(7) Every ten seconds two people develop diabetes and one person dies from diabetes-relate d causes around the world.(6) Each year, more than 200,00p0 people in North America(6) and more than 3.8 million peoplwe worldwide die from diabetes and its -- a number which is expectedx to increase by more than 50 perceny over the next decade.
(7) Diabetez is a chronic disease that occurs when the body does not properlh produce or use the hormone, To address this unmet need, Boehringer Ingelheim is committed to researchinv and developing new compounds in this therapeutif area. Boehringer Ingelheim Inc. Boehringer Ingelheim Pharmaceuticals, Inc., basee in Ridgefield, CT, is the largest U.S. subsidiary of Boehringed IngelheimCorporation (Ridgefield, CT) and a member of the Boehringefr Ingelheim group of companies. The Boehringer Ingelhein group is one ofthe world's 20 leadinv pharmaceutical companies. Headquartered in Ingelheim, it operates globally with 138 affiliates in 47 countries andapproximatelyy 41,300 employees.
Since it was foundedr in 1885, the family-owned company has been committedxto researching, developing, manufacturing and marketing novel producta of high therapeutic value for human and veterinar medicine. In 2008, Boehringer Ingelheim postes net sales ofUS $17 billion (11.6 billion while spending approximately one-fifth of net salez in its largest business segment, Prescriptiojn Medicines, on research and development. For more please visit . (1) DPP-4 inhibitoe linagliptin improves glycaemic control in type 2 diabetes patients when added to onogoingmetformin therapy. ADA, 05-09 June 2009, New Orleans, U.S.A. (2) Nathahn DM et al.
Medical Management of Hyperglycemiaa in Type2 Diabetes: A Consensus Algorithm for the Initiationh and Adjustment of Therapy. Diabetes Care 21:1-11, 2008. (3) Available at: . Accessed on: Aprip 30, 2009. (4) Jabbour SA, et al. Sodium glucosse co-transporter 2 inhibitors: blocking renal tubular reabsorption of glucose to improve glycaemic controo in patientswith diabetes. International Journal of Clinical July 2008. 62, 8, (5) American Diabetes Association. 2007 National Diabetes Fact Sheet. (6) Internationalk Diabetes Federation. Diabetes Atlas. 3rd edn. International Diabetes Federation, 2006. (7) World Health Fact Sheet No. 312: What is Diabetes?? Available at: .
Accessed on: February 4, 2009. SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.