The primary aim of this study is to evaluate the safety and tolerability of AZD1656 in T2DM patients treated with metformin and sulfonylurea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
Dose titration of oral suspension of AZD165 during 3 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 6 days
Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days
Research Site
San Diego, California, United States
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG
Time frame: AE will be collected from the time for randomisation until follow-up visit. Safety variables and vital signs will be measured at the pre-entry, during study days -2 to 10 and at the follow-up visit.
Pharmacokinetic variables: (Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)
Time frame: Blood samples for analysis of plasma concentrations of AZD1656 will be collected on study days 6 and 9. The samples for analysis of glipizide will be collected on study days -1 and 6.
Pharmacodynamic variables: 24 h plasma glucose, Insulin
Time frame: Samples for 24-hour plasma glucose and insulin will be collected on study days -1, 6 and 9.
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