The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Insulin
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Research Site
Chula Vista, California, United States
Systolic Blood Pressure, Change From Baseline to End of Treatment
Time frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Diastolic Blood Pressure, Change From Baseline to End of Treatment
Time frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Pulse, Change From Baseline to End of Treatment
Time frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Weight, Change From Baseline to End of Treatment
Time frame: Baseline is the day before first dose, end of treatment is last day of treatment
Clinically Relevant Change of Laboratory Variables
Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters
Time frame: Measured regularly from day before first dose to day after last dose
Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656
Dose-adjusted to a total daily dose of 100 mg due to titrated doses
Time frame: Measured last day of treatment
Maximum Plasma Concentration of AZD1656
Dose-adjusted to a morning dose of 50 mg due to titrated doses
Time frame: Measured following the morning dose last day of treatment
Time to Reach Maximum Plasma Concentration of AZD1656
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Time frame: Measured last day of treatment
Terminal Elimination Half-life of AZD1656
Time frame: Measured following the evening dose last day of treatment
Apparent Oral Clearance of AZD1656
Time frame: Measured last day of treatment
P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment
Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.
Time frame: Baseline is the day before first dose, end of treatment is last day of treatment
S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment
Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100
Time frame: Baseline is the day before first dose, end of treatment is last day of treatment
S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment
Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.
Time frame: Baseline is the day before first dose, end of treatment is last day of treatment