Phase 2 Trial of LX4211 Demonstrates Significant and Rapid Improvements in Multiple Parameters in Type 2 Diabetic Patients
January 20 2010 - 6:30AM
PR Newswire (US)
- Significant Improvements in Glycemic Control - Significant
Reduction in HbA1c within Four Weeks - Favorable Safety,
Cardiovascular and Metabolic Profile Observed THE WOODLANDS, Texas,
Jan. 20 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc.
(NASDAQ:LXRX), a biopharmaceutical company focused on discovering
breakthrough treatments for human disease, obtained positive
results from a recently completed Phase 2 study of LX4211 in
patients with type 2 diabetes mellitus. LX4211 is a once-per-day,
orally-delivered, small molecule drug candidate that inhibits the
sodium-dependent glucose transporter 2 (SGLT2), lowering the
accumulation of glucose in the body and reducing caloric load.
LX4211, dosed as a single agent, provided improvements in glycemic
control, demonstrating statistically significant benefits in the
primary and multiple secondary efficacy endpoints. "Results from
this important first trial of LX4211 in diabetic patients exceeded
our expectations," said Dr. Philip M. Brown, senior vice president
of clinical development at Lexicon. "Rapid improvement in multiple
parameters of diabetes, meaningful weight loss, a favorable safety
profile and the fact that LX4211-treated patients exhibited
improvements in clinically-important metabolic and cardiovascular
parameters within four weeks on a single agent is remarkable." The
recently completed study was a four-week, randomized, double-blind,
placebo-controlled study in 36 patients with type 2 diabetes.
Patients were randomized to receive either placebo (n=12) or
LX4211, 150 mg (n=12) or 300 mg (n=12), once daily for 28 days.
Patients were sequestered, provided a controlled diet and monitored
closely throughout the study period. There was a marked decrease in
fasting plasma glucose throughout the treatment period in both dose
groups, with reductions at week four of 53.4 mg/dl and 65.9 mg/dl
in the 150 mg and 300 mg dose groups, respectively, as compared to
15.1 mg/dl for placebo. These decreases in fasting plasma glucose
relative to placebo were statistically significant for both LX4211
dose groups (p=0.001 and p
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