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Clinical Trial Details

Trial ID: L7377
Source ID: NCT00995787
Associated Drug: Azd1656
Title: Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type II Diabetes Mellitus
Interventions: DRUG: AZD1656|DRUG: Placebo
Outcome Measures: Primary: Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG, 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. | Secondary: 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), 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, Samples for 24-hour plasma glucose and insulin will be collected on study days -1, 6 and 9.
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 75
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2009-10
Completion Date: 2010-02
Results First Posted:
Last Update Posted: 2010-02-26
Locations: Research Site, San Diego, California, United States
URL: https://clinicaltrials.gov/show/NCT00995787