This study will assess safety, tolerability, and effect of LIK066 on blood glucose in healthy subjects and in patients with T2DM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
138
Novartis Investigative Site
Miami, Florida, United States
Safety and tolerability of single and multiple dose(s) of LIK066: number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).
Time frame: Daily during treatment
Change in fasting and post-challenge plasma glucose after 2 weeks of treatment
Time frame: Baseline and End of Treatment
Pharmacokinetics: to measure the study drug concentration in blood and urine samples to be collected after drug administration
Time frame: Day 1 and End of Treatment
Change in fasting and post-challenge plasma glucose after a single dose and 2 weeks of treatment
Time frame: Baseline and End of Treatment
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