This protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of LX4211 in subjects with type 2 diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Single oral dose of two 150 mg tablets LX4211
Single oral dose of six 50 mg tablets LX4211
Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL)
Lexicon Investigational Site
San Antonio, Texas, United States
Maximum observed plasma concentration
Time frame: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Time at which maximum observed plasma concentration occurs
Time frame: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Half-life of the drug in plasma
Time frame: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Plasma glucose
Time frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Urinary glucose excretion
Time frame: Samples collected on Day -1 (Washout), day of dosing, and 24 and 48 hours post-dose (Follow-up).
Insulin
Time frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Peptide YY
Time frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Glucagon-like Peptide 1
Time frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
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