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Clinical Trial Details

Trial ID: L5108
Source ID: NCT02317484
Associated Drug: Ipragliflozin (Sglt2 Inhibitor)
Title: Investigation for Clinical Efficacy and Safety of Ipragliflozin 50mg and 100mg on Type II Diabetes
Acronym: HARUKAS
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Ipragliflozin (SGLT2 inhibitor)
Outcome Measures: Primary: HbA1c change level, After 52 weeks from the time of treatment initiation | Secondary: Sugar metabolism and body composition change levels, Change levels of the followings after 12, 24, 36, 52 weeks from the time of treatment initiation: HbA1c, blood glucose (both at fasting and after eating), glycoalbumin, body weight, BMI, serum lipid (TC、LDL-C、HDL-C、TG), blood pressure (both systolic and diastolic), After 12, 24, 36, 52 weeks from the time of the start of treatment|HbA1c achievement rate, The rate of less than HbA1c7.0% achievement after 12, 24, 36, 52 weeks from the time of treatment initiation, After 12, 24, 36, 52 weeks from the time of treatment initiation|Body composition and visceral fat change levels, Changes of the body composition examined by DEXA (Dual-energy X-ray absorptiometry) method and visceral fat examined by CT scan after 24 and 52 weeks from the time of treatment initiation, After 24 and 52 weeks from the time of treatment initiation
Sponsor/Collaborators: Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Collaborators: Osaka Saiseikai Nakatsu Hospital|Astellas Pharma Inc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 231
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2014-11
Completion Date: 2018-02-28
Results First Posted:
Last Update Posted: 2018-04-17
Locations: Osaka Saiseikai Nakatsu Hospital, Osaka, 530-0012, Japan
URL: https://clinicaltrials.gov/show/NCT02317484