This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

BYDUREON™ Was Associated With Significant And Sustained Glycemic Control At Four Years

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced results from the long-term extension of the DURATION-1 study, which showed that BYDUREON™ (exenatide extended-release for injectable suspension), the first and only once-weekly treatment for type 2 diabetes, was associated with clinically significant and sustained improvements in glycemic control during four years of treatment in adults with type 2 diabetes.

In the study, being presented at the 72nd Scientific Sessions of the American Diabetes Association in Philadelphia, patients completing four years of BYDUREON treatment experienced clinically significant improvements in A1C (1.7 percentage points) and fasting plasma glucose (-37 mg/dL) from baseline. A1C is a measure of average blood sugar over three months. Although BYDUREON is not indicated for weight loss, patients treated with BYDUREON also lost an average of 5.5 pounds from baseline.

“In this study, patients treated with just one dose per week of BYDUREON for four years experienced sustained improvement in glycemic control and showed reductions in certain cardiometabolic measures. The tolerability of BYDUREON also improved over time with long-term treatment,” said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. “The durability of treatment effectiveness and tolerability of BYDUREON are critically important in managing the chronic and progressive condition of type 2 diabetes.”

Patients treated with BYDUREON also experienced statistically significant reductions in certain cardiovascular risk markers, including systolic blood pressure (-1.6 mmHg), total cholesterol (-10.9 mg/dL), LDL cholesterol (-8.0 mg/dL) and triglycerides (-13 percent). No unexpected safety findings were observed with long-term BYDUREON therapy, and incidence of mild nausea, the most common adverse event during the controlled portion of the study, decreased over time (27 percent weeks 1-30; 1.6 percent weeks 180-212).

Study Details DURATION-1 compared the efficacy of once-weekly BYDUREON against twice-daily BYETTA ® (exenatide) injection in a 30-week, randomized, open-label study. Following the controlled portion of the study, 258 of the 295 intent-to-treat patients (87 percent) entered the extension study. A total of 68 percent of patients (n=176) completed four years of treatment, 55 percent of whom achieved the ADA-recommended A1C target of less than 7 percent. Primary endpoints were change from baseline to year four in A1C, and long-term safety and tolerability.

About BYDUREON™ (exenatide extended-release for injectable suspension) BYDUREON is the first and only once-weekly medicine to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes. It 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 nearly 80 countries worldwide. BYDUREON works with the body to help make its own insulin when needed, providing continuous glycemic control with just one dose per week. Using Alkermes’ proprietary technology for long-acting medications, the biodegradable microspheres in each dose of BYDUREON provide a controlled release of exenatide throughout the week. BYDUREON was approved in the U.S. in January 2012 and in Europe in June 2011.

BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise. BYDUREON is not recommended as the first medication to treat diabetes.

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,288.63 +155.93 0.86%
S&P 500 2,117.39 +12.89 0.61%
NASDAQ 5,008.0960 +44.5690 0.90%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs