Navigation Links
Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA(R) in DURATION-5 Study
Date:12/15/2009

trol as measured by A1C, and build upon other successful DURATION trials," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "More importantly, these results continue to suggest that if approved, exenatide once weekly could play an important role in advancing the treatment of type 2 diabetes by providing patients the opportunity for improved A1C control and weight loss with just one dose per week."

Approximately 80 percent of patients completed the study. Consistent with previous DURATION trials, the most frequently reported adverse event in both groups was nausea, reported less frequently by exenatide once weekly users (14 percent) than by BYETTA users (35 percent). There were no major hypoglycemic events. Cases of minor hypoglycemia in both groups were limited to patients using background sulfonylurea therapy.

The 24-week, open-label superiority study included approximately 250 participants with type 2 diabetes who were not achieving adequate glucose control using background therapies that included diet and exercise, metformin, sulfonylurea, thiazolidinediones or a combination of the agents. Patients were randomized to receive either exenatide once weekly or BYETTA. Patients in the exenatide once weekly treatment arm received 2 milligrams once a week, while patients in the BYETTA arm received 5 micrograms twice a day for the first four weeks and 10 micrograms twice a day for the remaining 20 weeks. The primary endpoint was reduction in A1C; secondary endpoints included change in body weight and fasting plasma glucose, safety and tolerability.

Amylin, Lilly and Alkermes submitted a new drug application (NDA) for exenatide once weekly to the U.S. Food and Drug Administration (FDA) in May 2009; the NDA was accepted for review in July 2009. Lilly will be responsible for marketing exenatide once weekly outside the U.S. and expects to submit a marketing application to the Europea
'/>"/>

SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDAs BYETTA(R) (Exenatide) Injection Update
2. Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study
3. The Lancet Publishes Direct Comparison Study Between Liraglutide and Exenatide
4. Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009
5. Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 2009
6. Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly
7. Exenatide Once Weekly Provided Superior Glucose Control With Weight Loss Compared to Sitagliptin or Pioglitazone in Head-to-Head DURATION-2 Study
8. Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback
9. After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008
10. Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight
11. Monotherapy BYETTA(R) (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes Experienced Improved Glycemic Control and Weight Loss
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... Tenn. , Dec. 17, 2014  Strategic Health ... management software solutions, today announced a strategic agreement with ... New Jersey regional marketplace.  This ... enhance the health and wellness solutions QualCare brings to ... and the surrounding region. QualCare plans ...
(Date:12/17/2014)... Dec. 17, 2014  Beamz Interactive, Inc. (OTCQB: ... products, today announced that it has signed an ... and supplier of innovative prosthetic, orthotic and assistive ... of the agreement, RSL Steeper will promote and ... configured for use within UK residential care facilities ...
(Date:12/17/2014)...  IGI Laboratories, Inc. (NYSE MKT: IG; "IGI" or ... of $125 million aggregate principal amount of 3.75% Convertible ... offered and sold only to qualified institutional buyers pursuant ... as amended (the "Securities Act"). The Notes ... year, payable semiannually in arrears on June 15 and ...
Breaking Medicine Technology:Strategic Health Services to collaborate with QualCare on Population Health and Wellness Technology for QualCare Members 2Strategic Health Services to collaborate with QualCare on Population Health and Wellness Technology for QualCare Members 3Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 2Beamz Interactive, Inc. Signs UK Distribution Agreement with RSL Steeper Limited 3IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 2IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 3IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 4
... Pfizer (NYSE: PFE ) today announced ... a privately held drug discovery and clinical development company. ... wholly owned subsidiary of Pfizer Inc.   ... Pfizer Inc: Working together for a healthier world™ ...
... 6 Orthopedics This Week, the most widely read ... announced the winners of its 2010 Best Spine Technologies ... inventors and engineers for extraordinary innovation, hard work and ... disease. Winners were recognized at a gala ...
Cached Medicine Technology:Orthopedics This Week Announces 2010 Best Spine Technology Award Winners 2
(Date:12/22/2014)... 22, 2014 Xarelto Lawsuit News ... of judges has granted a request to centralize pending ... District Court, Eastern District of Louisiana. The U.S. Judicial ... December 12 to transfer over 50 Xarelto cases–21 lawsuits ... the Louisiana court for consolidation under U.S. District Judge ...
(Date:12/22/2014)... City, NY (PRWEB) December 22, 2014 ... as a 2014 Professional Woman of the Year. Ms. ... in business. As the largest, most-recognized networking organization of ... and profession, the National Association of Professional Women is ... and nearly 300 Local Chapters. , “As a nurse, ...
(Date:12/22/2014)... Parker & Sons, Inc. a reliable and dependable ... services reports a record number of favorable reviews and ... As a company that has served the greater Phoenix ... is a business that is focused on excellent credibility ... top quality companies in Arizona that are focused on ...
(Date:12/21/2014)... Beverly Hills, Ca (PRWEB) December 21, 2014 ... Dr. Khanna was a guest at the Aspen Helicopters ... for kids and a Santa with sleigh, flown by ... the helicopter appeared invisible; only Santa with sleigh was ... both during day and night. Dr.Khanna has helped many ...
(Date:12/21/2014)... one of the best prom dresses online shops around ... its new collection of 2015 prom dresses, and announced ... prom dresses & other fashionable designs, up to 80 ... dress products and great customer services to its global ... best prom dresses online shops around the world by ...
Breaking Medicine News(10 mins):Health News:Panel Orders Xarelto Lawsuits Consolidated Into Multi-District Litigation Reports Alonso Krangle LLP 2Health News:Panel Orders Xarelto Lawsuits Consolidated Into Multi-District Litigation Reports Alonso Krangle LLP 3Health News:Panel Orders Xarelto Lawsuits Consolidated Into Multi-District Litigation Reports Alonso Krangle LLP 4Health News:National Association of Professional Women Announces Michelle M. Foley, Vice President of Operations of OTTR Chronic Care Solutions, a 2014 Professional Woman of the Year 2Health News:Parker & Sons Reports A Record Number Of Favorable References With Regard To Its Quality Services In 2014 2Health News:Parker & Sons Reports A Record Number Of Favorable References With Regard To Its Quality Services In 2014 3Health News:New Prom Dresses From One Of The Best Prom Dresses Online Shops, LunaDress Prom Shop 2
... pounds over 30 years, researchers say , TUESDAY, April 20 ... their lifetime steadily increase their risk for postmenopausal breast cancer, ... finds. , Earlier studies have linked excess weight with an ... is one of the few studies that traces the risk ...
... Epstein wanted to know whether cognitive behavior therapy ... couples therapy than when delivered as individual therapy. ... well, but women treated in couples therapy maintained ... individual therapy. Also, women suffering from depression in ...
... ... announced that the U.S. Food and Drug Administration (FDA) approved an Investigational New Drug ... stem cells (adult human). , ... San Diego, California (PRWEB) April 20, 2010 -- Stemedica Cell ...
... ... stomach issues. The Company chose four test markets to evaluate adoption of this unique ... ... are newly released to the retail market. Many health conscious adults need extra energy ...
... study by the Columbia Center for Children,s Environmental Health ... prenatal exposure to pollutants can adversely affect children,s cognitive ... New York City (NYC) study. Researchers ... aromatic hydrocarbons (PAHs) in Krakow had a significant reduction ...
... on pounds after prostatectomy nearly double odds of recurrence, one ... treated for prostate cancer who smoke or put on ... dying from the illness, two new studies show. , ... Cancer Research,s annual meeting in Washington, D.C. , In the ...
Cached Medicine News:Health News:Steady Weight Gain Boosts Late-Life Breast Cancer Risk 2Health News:Couples therapy can be the best choice for alcohol-dependent women with supportive spouses 2Health News:FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial 2Health News:Peoria and Baltimore Serve as Test Markets for New Spot On Energy Product 2Health News:Children's cognitive ability can be affected by mother's exposure to urban air pollutants 2Health News:Weight Gain, Smoking May Make Prostate Cancer Deadlier 2Health News:Weight Gain, Smoking May Make Prostate Cancer Deadlier 3Health News:Weight Gain, Smoking May Make Prostate Cancer Deadlier 4
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: