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Clinical Trial Details

Trial ID: L5985
Source ID: NCT02330406
Associated Drug: Anagliptin
Title: Randomized Evaluation of Anagliptin Versus Sitagliptin On Low-density lipoproteiN Cholesterol in Diabetes Trial
Acronym: REASON
Status: COMPLETED
Study Results: NO
Results:
Conditions: Dipeptidyl-Peptidase 4 Inhibitors|LDL Cholesterol|Glycosylated Hemoglobin|Diabetes Mellitus|Coronary Disease
Interventions: DRUG: Anagliptin|DRUG: Sitagliptin
Outcome Measures: Primary: Change in low-density lipoprotein cholesterol, 52-weeks|Change in glycated hemoglobin, 52-weeks | Secondary: Change in fasting glucose, 52-weeks|Change in fasting insulin, 52-weeks|Change in 1.5-Anhydro-D-glucitol, 52-weeks|Change in C peptide, 52-weeks|Change in total cholesterol, triglyceride, non high dencisty lipoprotein cholesterol, 52-weeks|Change in Apolipoprotein A1, Apolipoprotein B, Apolipoprotein E, 52-weeks|Change in Apolipoprotein B48, 52-weeks|Change in small dense low density lipoprotein, 52-weeks|Change in high sensitivity C-reactive protein, 52-weeks|Change in interleukin-6, 52-weeks|Change in cholesterol absorption marker (campesterol; sitosterol), 52-weeks|Change in cholesterol synthesis marker (lathosterol), 52-weeks|Change in high molecular weight adiponectin, 52-weeks|Change in ratio of albumin and creatinine in urine, 52-weeks|Progression, unchange, remission rate of microalbumin and macroalbumin in urine, 52-weeks|Change in estimated glomerular filtration rate, 52-weeks|Change in glycated hemoglobin stratified by body mass index and waist circumference, 52-weeks|Correlation between glycated hemoglobin and body mass index or waist circumference, 52-weeks|Change in intima-media thickness or flow mediated dilation, 52-weeks|Change in postprandial glucose, insulin and activated glucagon-like peptide-1, 52-weeks|Change in lipid profile and molecular size measured, 52-weeks|Change in fatty acid fraction, 52-weeks
Sponsor/Collaborators: Sponsor: Institute for Clinical Effectiveness, Japan
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 353
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-04
Completion Date: 2019-03
Results First Posted:
Last Update Posted: 2019-08-28
Locations: Department of Cardiovascular Medicine, Tomishiro Central Hospital, Tomishiro, Okinawa, 901-0243, Japan
URL: https://clinicaltrials.gov/show/NCT02330406

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress