THE WOODLANDS, Texas,
June 6, 2015 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that
the manuscript entitled "Sotagliflozin, a Dual SGLT1 and SGLT2
Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes"
was presented today in Boston at
the 75th Scientific Sessions of the American Diabetes
Association (ADA) as part of the 4th Annual Diabetes
Care Symposium by John B. Buse,
M.D., Ph.D. The manuscript was selected from over 150
manuscripts that were submitted and will be featured in a special
July issue of Diabetes Care and is available for download
online at care.diabetesjournals.org.
"The potential of this novel oral dual SGLT inhibitor to help
patients with type 1 diabetes manage their condition is exciting
news," commented Dr. Buse, Professor of Medicine and Chief of the
Division of Endocrinology at the University of
North Carolina, Chapel Hill.
In a Phase 2 study, 33 patients with type 1 diabetes were
treated with sotagliflozin, an oral dual SGLT1 and SGLT2 inhibitor,
or placebo in a randomized, double-blind trial assessing safety,
insulin dose, glycemic control, and other metabolic parameters over
29 days of treatment.
After 29 days of therapy the sotagliflozin treated patients
demonstrated reductions in A1C, body weight, and bolus, or mealtime
insulin, and an increase in the time spent in target glucose range
70–180 mg/dL. There was no reduction in basal insulin. Change from
baseline results are summarized below:
- A1C: -0.55% sotagliflozin vs. -0.06% placebo
(p=0.002)
- Number of Hypoglycemic Events/Patient/Day: -0.7 sotagliflozin
vs. -0.4 placebo (not significant)
- Body Weight -1.7 kg sotagliflozin vs. +0.5 kg placebo
(p=0.005)
- Bolus Insulin (primary endpoint): -32% sotagliflozin vs.
-6.4% placebo (p=0.007)
- Basal Insulin: -2.4% sotagliflozin vs. +0.2% placebo (not
significant)
From a safety perspective, 14 (88%) patients on sotagliflozin
reported adverse events compared with 12 (71%) patients on placebo.
No adverse events led to discontinuation from the study.
The most frequently reported treatment-emergent adverse
events were gastrointestinal disorders, which were reported by
eight sotagliflozin patients (50%) compared with three placebo
patients (18%), with the most notable imbalance being three reports
of nausea on sotagliflozin versus one on placebo. Nausea
generally occurred early, was mild in intensity and of short
duration. Two serious adverse events of diabetic ketoacidosis (DKA)
were reported in two patients using insulin infusion pumps and
treated with sotagliflozin. Both were assessed by the
investigators as insulin pump-related, and not related to study
drug. Of note, both cases of DKA were of classic
presentation, with blood glucose values above 350 mg/dL at the time
of hospitalization. Both patients fully recovered and resumed
treatment with study drug.
About Lexicon
Lexicon is a biopharmaceutical company
focused on developing breakthrough treatments for human
disease. Lexicon has clinical-stage drug programs for
diabetes, carcinoid syndrome, and other indications, all of which
were discovered by Lexicon's research team. Lexicon has used
its proprietary gene knockout technology to identify more than 100
promising drug targets. For additional information about
Lexicon and its programs, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains
"forward-looking statements," including statements relating to
Lexicon's clinical development of sotagliflozin (LX4211), including
characterizations of the results of and projected timing of
clinical trials and the potential therapeutic and commercial
potential of sotagliflozin. In addition, this press release
also contains forward-looking statements relating to Lexicon's
growth and future operating results, discovery and development of
products, strategic alliances and intellectual property, as well as
other matters that are not historical facts or information.
All forward-looking statements are based on management's current
assumptions and expectations and involve risks, uncertainties and
other important factors, specifically including those relating to
Lexicon's ability to meet its capital requirements, successfully
conduct clinical development of sotagliflozin and preclinical and
clinical development of its other potential drug candidates, obtain
necessary regulatory approvals, achieve its operational objectives,
obtain patent protection for its discoveries and establish
strategic alliances, as well as additional factors relating to
manufacturing, intellectual property rights, and the therapeutic or
commercial value of its drug candidates, that may cause Lexicon's
actual results to be materially different from any future results
expressed or implied by such forward-looking statements.
Information identifying such important factors is contained under
"Risk Factors" in Lexicon's annual report on Form 10-K for the year
ended December 31, 2014, as filed
with the Securities and Exchange Commission. Lexicon
undertakes no obligation to update or revise any such
forward-looking statements, whether as a result of new information,
future events or otherwise.
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SOURCE Lexicon Pharmaceuticals, Inc.