Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiaries, Takeda Global Research & Development Center, Inc. ("TGRD U.S."), and Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe"), announced today the initiation of the Company's Phase 3 clinical trial program for TAK-875, an investigational therapy for type 2 diabetes.
The program will be conducted across the United States (U.S.), Latin America, and Europe. TAK-875 is the first GPR40 agonist to reach late stage (Phase 3) clinical development.
Completed studies of TAK-875, discovered by Takeda, have suggested glucose-lowering effects in patients with type 2 diabetes by enhancing glucose-dependent insulin secretion.
"Takeda is committed to enhancing the clinical investigation of TAK-875 in order to accelerate the development of a potential new type 2 diabetes treatment option for patients and healthcare professionals," said Thomas Strack, M.D., vice president, clinical science, Takeda Global Research & Development Center, Inc., U.S. "An outcome of our robust focus on diabetes over many years, TAK-875 was discovered by Takeda based on our GPCR research and is the first GPR40 agonist to reach late stage (Phase 3) clinical development. TAK-875 is being developed globally, with Phase 3 trials already underway in Japan."
The first Phase 3 trial in the U.S./Europe program, a double-blind, randomized, 24-week safety and efficacy study, will enroll approximately 450 patients with type 2 diabetes who are not adequately controlled on diet and exercise, at approximately 140 sites in the U.S., Latin America, and Europe. The study's primary endpoint will be the change in HbA1c at week 24 while other endpoints will include the assessment of a clinically meaningful response based on reaching HbA1c targets, changes in fasting plasma glucose (FPG) and two-hour postprandial plasma glucose (PPG). Results are expected by 2014.
About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. The number of people worldwide living with diabetes (both type 1 and type 2) has reached 366 million, and the disease is responsible for 4.6 million deaths each year. Type 2 diabetes is a progressive and chronic condition and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take medications in order to help manage glucose control. The global health care expenditures to treat and prevent diabetes and its complications have reached $465 billion.
TAK-875 is one of Takeda's investigational therapies for type 2 diabetes. TAK-875 is a selective agonist of GPR40, one of the G-protein-coupled receptors that are expressed in pancreatic islet cells. GPR40 agonists have a mechanism of action for type 2 diabetes different from that of sulfonylureas (such as glimepiride). They work by selectively improving glucose-dependent insulin secretion with a potential for reduced risk of hypoglycemia. Additional Phase 3 clinical trials for TAK-875 were initiated in Japan in September 2011.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.
About Takeda Global Research & Development Centre (Europe) Ltd.
Based in London, England, Takeda Global Research & Development Centre (Europe) Ltd. (TGRD Europe) is a subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. TGRD Europe seeks to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, neurology, oncology and other conditions.
SOURCE Takeda Pharmaceutical Company Limited