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
$1 buys you full access to ALL of TheStreet's Subscription Services! Learn More

Data From Post-Hoc Analyses Presented At EASD Examine Safety Profile Of Linagliptin In Adults With Type 2 Diabetes

Stocks in this article: LLY

RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 24, 2013 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (Lilly; NYSE: LLY) today announced results from two post-hoc, pooled analyses of data from placebo-controlled clinical trials, which examined the safety of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin in adults with type 2 diabetes (T2D). These data were presented at the 49 th Annual Meeting of the European Association for the Study of Diabetes (EASD).

Linagliptin, which is marketed as TRADJENTA ® (linagliptin) tablets in the U.S., is a once-daily, 5 mg tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). TRADJENTA has not been studied in patients with a history of pancreatitis, and it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRADJENTA.

G eneral safety analysis  Findings from a pooled, post-hoc analysis of safety data from 22 linagliptin clinical trials with 7,400 adults with T2D (4,810 received linagliptin, 2,590 received placebo) included the following 1:

  • The hypoglycemic incidence rate for linagliptin compared with placebo was 11.5 percent vs. 14 percent, respectively
  • Overall incidence of adverse events (AE) or serious adverse events (SAE) with linagliptin was similar to placebo (AE 56.5 percent versus 61.2 percent, and SAE 4.8 percent versus 6.3 percent, respectively)

"Drug safety is an important consideration in the selection of appropriate treatments for adults with type 2 diabetes, as different populations often may have drug contraindications and require dose adjustments to help manage their disease," said Prof. Nikolaus Marx, Professor of Medicine and Cardiology, University Hospital of Aachen, Germany. "The results presented today examine the safety profile of linagliptin."

R enal safety data in the elderly  Results from another post-hoc analysis 2 evaluated pooled data from seven randomized, placebo-controlled phase III clinical trials including 1,293 adults with T2D who were 65 years or older showed:

  • Overall renal function, as assessed by estimated glomerular filtration rate (eGFR), was not significantly altered by treatment with linagliptin from baseline to week 24, compared with placebo (adjusted mean ± SE eGFR of −1.8 ± 0.7 mL/min for linagliptin vs. −1.1 ± 0.9 mL/min for placebo). The majority of patients in the linagliptin group had mild renal impairment with similar proportions of mild, moderate and severe renal impairment found in the placebo group.
  • Renal and urinary AEs were experienced by 5.5 percent and 4.3 percent of linagliptin and placebo patients, respectively
  • Incidence of investigator-defined hypoglycemia was lower in patients who received linagliptin compared with placebo (21.3 percent versus 24.7 percent), with most events occurring in trials that included a sulfonylurea or basal insulin as background therapy
  • Acute renal failure occurred in 0.5 percent and 0.2 percent of linagliptin and placebo patients, respectively

"The results from these pooled analyses continued to demonstrate that linagliptin is a treatment option for a wide range of adults with type 2 diabetes, including the elderly and those with renal impairment," said Christophe Arbet-Engels, MD, PhD, vice president, metabolic clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "These findings provide healthcare providers with additional information they may need to help manage the increasing number of adults with type 2 diabetes they work with every day."

The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and several other regulatory authorities worldwide have approved linagliptin for the treatment of adults with T2D as monotherapy or in combination with metformin, metformin + sulfonylurea, and as add-on therapy to insulin. With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment. 3,4

Wh at are TRADJENTA tablets?  TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

1 of 4

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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!

Markets

DOW 17,827.75 +12.81 0.07%
S&P 500 2,072.83 +5.80 0.28%
NASDAQ 4,787.3170 +29.0650 0.61%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

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