This Day On The Street
Continue to site
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

Phase IIa Study Assessing Safety And Tolerability Of Dapagliflozin After 14 Days As Add-on To Insulin In Adult Patients With Type 1 Diabetes Presented At The 2013 American Diabetes Association Scientific Sessions®

AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a two-week Phase IIa pilot study evaluating dapagliflozin added to insulin in 70 adult patients with sub-optimally controlled type 1 diabetes. Results from this study showed that in patients treated with dapagliflozin, no subjects discontinued due to lack of glycemic control, few genital and urinary tract infections were reported and hypoglycemia was observed in all treatment groups. In addition, mean daily blood glucose derived from 7-point glucose measurements trended downward in all treatment groups through day seven and reductions in total daily insulin dosing at day seven were observed with dapagliflozin. These findings will be presented Sunday, June 23, in a late-breaking poster session at the 73 rd Scientific Sessions ® of the American Diabetes Association in Chicago.

In this study, there was one case of major hypoglycemia in the dapagliflozin 10 mg group that led to discontinuation. The proportion of adverse events (excluding hypoglycemia events) was 61.5% for the placebo group and 38.5%, 46.7%, 50.0% and 40.0% for the dapagliflozin 1, 2.5, 5 and 10 mg groups added on to background insulin, respectively. The proportion of hypoglycemia events was 61.5% for the placebo group and 92.3%, 60.0%, 78.6% and 66.7% for the dapagliflozin 1, 2.5, 5 and 10 mg groups added on to background insulin, respectively. There were two cases of urinary tract infection reported (one in the placebo group and one in the dapagliflozin 2.5 mg group) and two cases of genital infections (one in the dapagliflozin 1 mg group and one in the dapagliflozin 5 mg group). One serious adverse event was reported (gastroparesis) in the dapagliflozin 5 mg group, which was not considered treatment-related, and was the only adverse event that led to discontinuation.

“Many people with type 1 diabetes may benefit from other treatment options in addition to insulin,” said Robert Henry, M.D., director, Center for Metabolic Research VA San Diego Healthcare System and primary study investigator. “These preliminary data with dapagliflozin added on to insulin are encouraging and support the need for further studies.”

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
Only $9.95
14-Days Free
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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 17,837.14 +24.95 0.14%
S&P 500 2,091.71 +2.57 0.12%
NASDAQ 5,121.04 +18.2320 0.36%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs