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Clinical Trial Details

Trial ID: L5104
Source ID: NCT00819884
Associated Drug: Azd1656
Title: To Evaluate 24-hr Glucose After OD vs BD AZD1656
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type II Diabetes
Interventions: DRUG: AZD1656
Outcome Measures: Primary: 24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose), Repeated sampling during the 24 hour period on day -1, 4 and 8 | Secondary: 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), 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, Repeated sampling at pre-specified timepoints on day 4 and 8|Pharmacodynamics (S-Insulin AUC0-24 and C-peptide AUC0-24), Repeated sampling during the 24 hour period on day -1, 4 and 8
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2009-01
Completion Date: 2009-05
Results First Posted:
Last Update Posted: 2009-05-07
Locations: Research Site, San Antonio, Texas, United States
URL: https://clinicaltrials.gov/show/NCT00819884