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Clinical Trial Details

Trial ID: L6527
Source ID: NCT00817778
Associated Drug: Azd1656
Title: Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00817778/results
Conditions: Type 2 Diabetes
Interventions: DRUG: AZD1656|DRUG: Placebo
Outcome Measures: Primary: Systolic Blood Pressure, Change From Baseline to End of Treatment, 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, 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, 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, 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, Measured regularly from day before first dose to day after last dose | Secondary: 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, Measured last day of treatment|Maximum Plasma Concentration of AZD1656, Dose-adjusted to a morning dose of 50 mg due to titrated doses, Measured last day of treatment|Time to Reach Maximum Plasma Concentration of AZD1656, Measured last day of treatment|Terminal Elimination Half-life of AZD1656, Measured following the afternoon dose last day of treatment|Apparent Oral Clearance of AZD1656, 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 a mixed-effect ANOVA model, using treatment as fixed effect 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., 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 a mixed-effect ANOVA model, using treatment as fixed effect 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., 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 a mixed-effect ANOVA model, using treatment as fixed effect 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., Baseline is the day before first dose, end of treatment is last day of treatment
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 27
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2009-01
Completion Date: 2009-07
Results First Posted: 2012-11-16
Last Update Posted: 2012-11-16
Locations: Research Site, San Antonio, Texas, United States
URL: https://clinicaltrials.gov/show/NCT00817778