This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of LX4211 following once daily oral administration in subjects with type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Subjects will receive LX4211 once daily for 7 days
Subjects will receive LX4211 placebo once daily for 7 days
Lexicon Investigational Site
Anniston, Alabama, United States
Lexicon Investigational Site
Chula Vista, California, United States
Lexicon Investigational Site
Edgewater, Florida, United States
Lexicon Investigational Site
Minneapolis, Minnesota, United States
Change from baseline in postprandial glucose
Time frame: baseline to 7 days
Number of subjects experiencing an adverse event
Time frame: 7 days
Change from baseline in fasting plasma glucose
Time frame: baseline to 7 days
Change from baseline in glucagon-like peptide 1 (Glp-1)
Time frame: baseline to 7 days
Area Under Curve (AUC)
Time frame: Days 1 and 7; predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lexicon Investigational Site
San Antonio, Texas, United States
Lexicon Investigational Site
Renton, Washington, United States