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Clinical Trial Details

Trial ID: L4400
Source ID: NCT01512849
Associated Drug: Ta-7284 Low
Title: A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01512849/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: TA-7284 Low|DRUG: TA-7284 High
Outcome Measures: Primary: Effect of Renal Function on Maximum Plasma Concentration of TA-7284, For 72 hours after each administration|Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284, For 72 hours after each administration|Effect of Renal Function on Urinary Glucose Excretion of TA-7284, For 24 hours after each administration|Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284, The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC - urinary glucose excretion) on the preceding day and on the day of administration., For 24 hours after each administration | Secondary: Adverse Events, Incidence and severity of AEs, Upto approximately 14 days after last administration|12-lead Electrocardiogram (ECG), Change from baseline in ECG parameters, For 72 hours after each administration|Vital Signs, Change from baseline in Vital signs (BP, PR and BT), For 72 hours after each administration|Clinical Laboratory Tests, Change from baseline in Clinical laboratory tests, For 72 hours after each administration
Sponsor/Collaborators: Sponsor: Mitsubishi Tanabe Pharma Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-01
Completion Date: 2012-09
Results First Posted: 2014-06-11
Last Update Posted: 2014-06-11
Locations: Reserch site, Kanto, Japan
URL: https://clinicaltrials.gov/show/NCT01512849