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Clinical Trial Details

Trial ID: L3897
Source ID: NCT00856908
Associated Drug: Azd1656
Title: Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00856908/results
Conditions: Type II 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 following the morning dose 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 evening 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 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., 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, 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., 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: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2009-02
Completion Date: 2009-08
Results First Posted: 2012-11-26
Last Update Posted: 2012-12-06
Locations: Research Site, Chula Vista, California, United States
URL: https://clinicaltrials.gov/show/NCT00856908