Navigation Links
DURATION-6 Top-Line Study Results Announced
Date:3/3/2011

underway and, when complete, the companies plan to submit the full study results for publication.

"While this study did not meet its primary endpoint, these results reinforce the important role of GLP-1 receptor agonists in the treatment of type 2 diabetes," said Gwen Krivi, M.D., vice president, product development, Lilly Diabetes. "This is the sixth DURATION study showing once-weekly BYDUREON had a significant A1C reduction from baseline. If approved, BYDUREON could provide millions of patients a once-weekly treatment option."

BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which has been available in the U.S. since June 2005 and is used in more than 70 countries worldwide to improve glycemic control in adults with type 2 diabetes.

The New Drug Application for BYDUREON was submitted to the U.S. Food and Drug Administration (FDA) in 2009. The FDA issued a complete response letter and requested further data in October 2010. The companies plan to submit a response in the second half of 2011.

Study Design

DURATION-6 is the sixth in a series of studies comparing BYDUREON to other type 2 diabetes medications. The 26-week, head-to-head, open-label, superiority study enrolled approximately 900 patients in 19 countries outside the U.S. with type 2 diabetes who were not achieving adequate A1C control with diet and exercise in conjunction with metformin, a sulfonylurea, metformin plus a sulfonylurea or metformin plus Actos® (pioglitazone HCI). Patients had an average type 2 diabetes diagnosis of more than eight years. The patients were randomized to receive subcutaneous injection of either BYDUREON (2 mg, once per
'/>"/>

SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. CuraGen Announces Top-Line Phase II Results on Velafermin
2. Top-Line Efficacy Data Presented from Phase 2 Trial of Alemtuzumab in Multiple Sclerosis
3. Exelixis Reports Top-Line Results of the Phase 2 Trial of XL784 in Patients With Proteinuria Associated With Diabetic Nephropathy
4. Schering-Plough Reports Top-Line Results of the IDEAL Study
5. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
6. Statement From the Lupus Foundation of America Regarding the Release of Top-Line Results From a Study of Rituxan for the Treatment of Lupus
7. Cardica Reports Positive Top-Line Results and Submits 510(k) for PAS-Port(R) Proximal Anastomosis System in Cardiac Bypass Surgery
8. Inspires Phase 3 CF Trial, Using PARIs Nebulizer & Compressor, Shows Positive Top-Line Results
9. Medivation to Host Conference Call at 5 p.m. EDT Monday to Discuss Top-Line Phase 2 Study Results in Huntingtons Disease
10. Medivation Announces Positive Top-Line Results From Phase 2 Dimebon Study in Huntingtons Disease
11. NicOx Announces Top-Line Results From Naproxcinod 52-Week 301 Safety Extension
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/18/2014)... November 18, 2014 This report ... the overall new requirements of application dossiers for medical ... but also provides the guidance of practical operation ... products entry into the Chinese medical device market. ... market is one of segment market of the most ...
(Date:11/18/2014)...  Isis Pharmaceuticals, Inc. (NASDAQ: ISIS ) announced ... December 8, 2014 at 9:00 a.m. Eastern Time to discuss ... American Society of Hematology Annual Meeting and Exposition.  ... dialing 877-443-5662 or access the webcast at www.isispharm.com .  ... at the same address. ABOUT ISIS PHARMACEUTICALS, ...
(Date:11/18/2014)... Tocagen Inc. today announced that interim data ... at six months for recurrent high grade glioma (HGG) ... to published benchmarks. HGG includes glioblastoma, the most common ... were delivered in an oral presentation at the 19 th ... Society for Neuro-Oncology (SNO) by Tim Cloughesy , ...
Breaking Medicine Technology:Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 2Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 3Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 4Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 5Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 6Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 7Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China (2014 Edition) 8Isis Pharmaceuticals to Host Webcast to Discuss ISIS-FXI Rx Data Presented at the ASH Annual Meeting 2Isis Pharmaceuticals to Host Webcast to Discuss ISIS-FXI Rx Data Presented at the ASH Annual Meeting 3Interim Data Show Increased Median Overall Survival of Recurrent Brain Cancer Patients Treated with Tocagen's Toca 511 & Toca FC, Compared to Published Benchmarks 2Interim Data Show Increased Median Overall Survival of Recurrent Brain Cancer Patients Treated with Tocagen's Toca 511 & Toca FC, Compared to Published Benchmarks 3Interim Data Show Increased Median Overall Survival of Recurrent Brain Cancer Patients Treated with Tocagen's Toca 511 & Toca FC, Compared to Published Benchmarks 4Interim Data Show Increased Median Overall Survival of Recurrent Brain Cancer Patients Treated with Tocagen's Toca 511 & Toca FC, Compared to Published Benchmarks 5
... SILVER SPRING, Md., May 6, 2011 The U.S. Food ... allow a new group of patients at risk of stroke ... RX Acculink carotid stent. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO ) ... neck bring blood to the brain. The blood flow in ...
... BEACH, Calif., May 6, 2011 Yesterday, the ... Novartis drug Afinitor® (everolimus) for the treatment of ... less than five percent of all pancreatic cancer ... aggressive than the more common form of pancreatic ...
Cached Medicine Technology:FDA Expands Approved Use For Carotid Stent 2FDA Expands Approved Use For Carotid Stent 3FDA Approves Novartis Drug Afinitor to Treat Pancreatic Neuroendocrine Tumors 2
(Date:11/18/2014)... By Dennis Thompson ... (HealthDay News) -- An experimental antibody drug could prove ... who have side effects with cholesterol-lowering statin medications. ... at the American Heart Association annual meeting in Chicago. ... is currently the most widely used alternative to statins, ...
(Date:11/18/2014)... Nov. 18, 2014 (HealthDay News) -- Cocaine users can ... hard to detect, which can put them at increased ... warns. Researchers in Chicago compared heart imaging test ... didn,t use the illegal drug. Those using cocaine ... smallest blood vessels, which were considered significant when compared ...
(Date:11/18/2014)... Recently, BellasDress has announced the launch of 85 ... and using comfortable fabrics, the new styles of prom dresses ... of wonderful holiday gifts in a variety of colors and ... dresses, and they are created by top designers,” said the ... great addition to our sales team and more than one ...
(Date:11/18/2014)... 2014 Global Partnership for ... telehealth platform to bring quality healthcare to populations ... GPT created Global Partnership for TeleHealth Missions (GPTM), ... telehealth network. GPTM focuses specifically on medical ... disaster relief organizations. , Michael D’Ambrosio, ...
(Date:11/18/2014)... Altec Products, Inc., a leader in enterprise ... sponsorship of the 2014 Great Plains User Conference (GPUC) ... the Fargo, ND Microsoft Campus. GPUC is an annual ... sessions and structured networking opportunities. , The two-day ... for users to learn how to extend the power ...
Breaking Medicine News(10 mins):Health News:Experimental Cholesterol-Lowering Drug Effective, Study Reports 2Health News:Experimental Cholesterol-Lowering Drug Effective, Study Reports 3Health News:Cocaine Can Cause Heart Problems: Study 2Health News:85 New Models Of White Prom Dresses From BellasDress.com Online For Sale 2Health News:Global Partnership for TeleHealth (GPT) is Focused on Using the telehealth Platform to Bring Quality Healthcare to Populations in Need Worldwide 2Health News:Altec Joins the 2014 Great Plains User Conference (GPUC) as a Gold Sponsor, Demonstrating the Capabilities of Certified for Microsoft Dynamics Product doc-link 2Health News:Altec Joins the 2014 Great Plains User Conference (GPUC) as a Gold Sponsor, Demonstrating the Capabilities of Certified for Microsoft Dynamics Product doc-link 3
... Bag(TM) Events Bring Educational Outreach to Senior Centers, ... TAMPA, Fla., July 10 Eight out of ten older ... high blood pressure or diabetes. According to CVS/pharmacy, fifty percent ... or more prescriptions regularly. With increased use of medications, both ...
... Connectyx Technologies Holdings Group, Inc. (Other OTC: CTYX) is pleased ... as the market leader in the Electronic Personal Health Record ... yesterday,s Nationwide Teleconference. Mr. Schuman went on to state ... members by the end of 2011 through continually expanding its ...
... The Quigley Corporation, (Nasdaq: QGLY ) , ... announced that Dr. Richard Rosenbloom has resumed providing services to the ... from the Company in late May, 2009. , , Ted ... pleased to have Dr. Rosenbloom again serving our Pharma subsidiary and ...
... ... Not only does the company take great pride in their surgical instruments, Spectrum focuses on ... ... that on June 17, 2009, for the 2nd consecutive year, the company was recipient of ...
... ... Allegheny General Hospital. , ... July 9, 2009 -- A Washington County woman is recovering well today after undergoing a ... of Canonsburg, is one of just a handful of bariatric patients in the region to ...
... , SOLON, Ohio , July 9 Nestle USA,s ... with the Food and Drug Administration (FDA) and the Centers ... E. coli O157:H7 illnesses associated with the consumption of raw, ... evidence of E. coli O157:H7 in a retained production sample ...
Cached Medicine News:Health News:The National Council on Aging and CVS/pharmacy Educate Tampa Seniors on Medication Management and How to Save Money on Prescription Drugs 2Health News:The National Council on Aging and CVS/pharmacy Educate Tampa Seniors on Medication Management and How to Save Money on Prescription Drugs 3Health News:The National Council on Aging and CVS/pharmacy Educate Tampa Seniors on Medication Management and How to Save Money on Prescription Drugs 4Health News:Connectyx Looks to Establish Market Leadership with MedSync and MedFlash Product Line As Stated During Nationwide Teleconference 2Health News:Connectyx Looks to Establish Market Leadership with MedSync and MedFlash Product Line As Stated During Nationwide Teleconference 3Health News:Dr. Richard Rosenbloom Resumes Services To The Quigley Corporation's Pharma Subsidiary 2Health News:Dr. Richard Rosenbloom Resumes Services To The Quigley Corporation's Pharma Subsidiary 3Health News:Spectrum Surgical Instruments Receives 2009 World Class Customer Service Award 2Health News:Canonsburg Woman Undergoes Robot-Assisted Weight Loss Procedure at AGH 2Health News:Canonsburg Woman Undergoes Robot-Assisted Weight Loss Procedure at AGH 3Health News:Canonsburg Woman Undergoes Robot-Assisted Weight Loss Procedure at AGH 4Health News:Nestle(R) TOLL HOUSE(R) Refrigerated Cookie Dough Recall Update - July 9, 2009 2
... Dehydroepiandrosterone sulfate (DHEA-S) is the sulfate ester ... by enzymatic conversion of DHEA in adrenal ... C19 steroid secreted by the adrenal cortex, ... estrogen biosynthesis. DHEA possesses relatively weak androgenic ...
... sulfate (DHEA-S) is the sulfate ester of ... enzymatic conversion of DHEA in adrenal and ... steroid secreted by the adrenal cortex, and ... biosynthesis. DHEA possesses relatively weak androgenic activity, ...
Inquire...
... It is a compact Latex based reagent kit ... well as to determine the level of RF ... patient sera. The kit includes antigen coated fine ... control sera in plastic squeezable dropping bottles, re-usable ...
Medicine Products: