The purpose of this study is to compare the 24-hour glucose profiles in diabetic patients treated with metformin following once daily and twice daily oral dosing
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
Oral suspension
Research Site
San Antonio, Texas, United States
24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose)
Time frame: Repeated sampling during the 24 hour period on day -1, 4 and 8
Safety and tolerability (Adverse events (AEs) during the study, blood pressure (BP), pulse rate, safety laboratory variables (incl. glucose) and investigator's interpretation of electrocardiogram (ECG)
Time frame: Frequent measurements during the study period
Pharmacokinetic variables (Area under the plasma conc vs. time curve (AUC0-24), maximum plasma conc (Cmax), time to reach maximum plasma conc(tmax), terminal elimination half-life and apparent oral clearance
Time frame: Repeated sampling at pre-specified timepoints on day 4 and 8
Pharmacodynamics (S-Insulin AUC0-24 and C-peptide AUC0-24)
Time frame: Repeated sampling during the 24 hour period on day -1, 4 and 8
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