Navigation Links
Takeda Initiates Cardiovascular Outcomes Trial for Alogliptin, An Investigational Treatment for Type 2 Diabetes
Date:8/28/2009

DEERFIELD, Ill. and OSAKA, Japan, Aug. 28 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, today jointly announced that the latter has received notification that the U.S. Food and Drug Administration (FDA) has agreed to the study design for a cardiovascular (CV) outcomes trial titled EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) for alogliptin, a selective dipeptidyl peptidase IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.

The alogliptin New Drug Application (NDA) was submitted in December 2007, and in the complete response for alogliptin dated June 26, 2009, the FDA requested an additional CV safety trial that satisfies the criteria outlined in the December 2008 "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes." The EXAMINE study is designed to comply with this Guidance.

"Takeda received FDA agreement to the design of the CV study and we are pleased to move forward with the study and collecting additional safety data so that the FDA can continue the review of the alogliptin NDA," said Nancy Joseph-Ridge, M.D., General Manager, Pharmaceutical Development Division. "We are committed to conducting this study to satisfy the CV safety requirements, leading to the enhancement of the product profile of alogliptin. While this trial is dependent on the occurrence of CV events, at this point we anticipate that we will be able to submit interim results to the FDA approximately two years after the study begins that will meet the FDA Guidance criteria for drug approval."

Outline of the EXAMINE Trial

    Title:             A Multicenter, Randomized, Double-Blind, Placebo-
                       Controlled Study to Evaluate Cardiovascular Outcomes
                       Following Treatment with Alogliptin in Addition to
                       Standard of Care in Subjects with Type 2 Diabetes and
                       Acute Coronary Syndrome

    Study Start:       September 2009

    Study Completion:  December 2014

    No. of Patients:   Approximately 5,400

    Primary Outcome:   Time from randomization to the occurrence of the
                       Primary Major Adverse Cardiac Events defined as
                       a composite of cardiovascular death, nonfatal
                       myocardial infarction and nonfatal stroke

    Secondary Outcome: Time from randomization to the occurrence of the
                       Secondary Major Adverse Cardiac Events defined
                       as a composite of cardiovascular death, nonfatal
                       myocardial infarction, nonfatal stroke and urgent
                       revascularization due to unstable angina

    Study Sites:       Approximately 1,000 sites in the U.S., Europe, Asia

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 striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate Web site, 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 and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about these Takeda companies, visit www.tpna.com.


'/>"/>
SOURCE Takeda Pharmaceutical Company Limited
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
2. Takeda Doses First Patient in a U.S. Phase 1 Study of Hematide(TM) to Treat Chemotherapy Induced Anemia
3. Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes
4. Takedas Investigational PPI TAK-390MR Demonstrated Higher Healing Rates Compared to Lansoprazole as the Severity of Erosive Esophagitis Grade Increased, a New Integrated Analysis Showed
5. Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer
6. Takeda Initiates Two Phase III Studies with Vedolizumab (MLN0002) in Patients with Inflammatory Bowel Disease
7. Takeda to Revise Timing of Alogliptin and Alogliptin/ACTOS MAA Filings in Europe
8. Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
9. Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)
10. Carrington Subsidiary DelSite Initiates Critical Toxicology Studies of Its Nasal Powder Bird Flu Vaccine
11. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... -- Glycotope GmbH, a clinical-stage immuno-oncology company ... of Dr. Alfredo Zurlo as Chief Medical ... many years clinical experience and a proven track record ... was at Mologen AG where he was Chief Medical ... Zurlo held various positions at F Hoffmann La Roche ...
(Date:4/28/2016)... , April 28, 2016  While Abbott,s ... complement the company,s valve repair and stent business, ... also places Abbott more firmly into patient monitoring.  ... the fastest growing device areas, with double-digit growth ... recent report,  Advanced Remote Patient Monitoring ...
(Date:4/28/2016)... April 28, 2016 ... George Phillips und Stephen Schmidt ... ArisGlobal®, ein führender Anbieter cloudbasierter ... heute bekannt, dass neue Führungskräfte zum Team ... sind, die vielfältige Erfahrungen mitbringen.  Dies wird ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... April 29, 2016 , ... Coast Dental Fort Stewart is celebrating its ... location in the Exchange Furniture Mall at 112 Vilseck Road in Fort Stewart. There ... TV. Plus attendees will have the opportunity to meet general dentists Thomas Richards, DDS, ...
(Date:4/29/2016)... Kansas City, Missouri (PRWEB) , ... April 29, 2016 , ... ... Unlike traditional crutches which put pressure on the armpits, the M+D Crutch evenly distributes ... less strain on their wrists and hands when using the crutches than with other ...
(Date:4/29/2016)... ... April 29, 2016 , ... Dr. Robert Mondavi, one of the ... Cosmetic dentistry is a fast-growing field as more patients are discovering the many different ... more about the options currently available to them and which ones might work for ...
(Date:4/29/2016)... ... April 29, 2016 , ... Jvion, the market ... funding led by Eastside Partners, with participation from existing investor Martin Ventures. ... and accelerate its technology and product roadmap. , “Jvion is experiencing ...
(Date:4/29/2016)... ... 2016 , ... The infertility specialists at HRC Fertility/Orange County (HRC/OC) -- Dr. ... Potter -- are proud of the recent release of their 2014 in vitro fertilization ... published the latest verified data for 375 U.S. member clinics. *Preliminary data shows ...
Breaking Medicine News(10 mins):