This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
299
Subjects will receive 75 mg LX4211 once daily
Subjects will receive 200 mg LX4211 once daily.
Subjects will receive 400 mg LX4211 once daily.
Change From Baseline in HbA1c to Week 12
Time frame: 12 weeks
Number of Participants Achieving a HbA1c Value of <7% at Week 12
Time frame: 12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12
Time frame: 12 weeks
Change From Baseline in Body Weight at Week 12
Time frame: 12 weeks
Change From Baseline in Systolic Blood Pressure (SPB) at Week 12
Time frame: 12 weeks
Change From Baseline in Triglycerides at Week 12
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Subjects will receive 200 mg LX4211 twice daily.
Subjects will receive placebo once daily.
Lexicon Investigational Site
Anaheim, California, United States
Lexicon Investigational Site
Carmichael, California, United States
Lexicon Investigational Site
Greenbrae, California, United States
Lexicon Investigational Site
La Jolla, California, United States
Lexicon Investigational Site
Northridge, California, United States
Lexicon Investigational Site
Orange, California, United States
Lexicon Investigational Site
Pismo Beach, California, United States
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Tarzana, California, United States
Lexicon Investigational Site
Tustin, California, United States
Lexicon Investigational Site
Denver, Colorado, United States
...and 46 more locations