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Clinical Trial Details

Trial ID: L3980
Source ID: NCT03076112
Associated Drug: Ipragliflozin
Title: Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Ipragliflozin|DRUG: Sitagliptin
Outcome Measures: Primary: Glycated hemoglobin, Change of HbA1c after 24 weeks' treatment, Baseline, week 12, week 24 | Secondary: Glycemic target goal achievement, Glycemic target goal achievement (HbA1c \< 7%) at week 24, Baseline, week 12, week 24|Body weight, Change of body weight at week 24, Baseline, week 12, week 24|Body fat mass, Change of body fat mass at week 24, Baseline, week 24|Fasting plasma glucose level, Change of fasting plasma glucose level at week 24, Baseline, week 12, week 24|Postprandial 2hr glucose level, Changes of postprandial 2hr glucose level at week 24, Baseline, week 12, week 24|Blood Pressure, Change of systolic/diastolic blood pressure at week 24, Baseline, week 12, week 24|Triglyceride/HDL-cholesterol ratio, Changes of triglyceride/HDL-cholesterol ratio at week 24, Baseline, week 12, week 24|Uric acid, Changes of uric acid at week 24, Baseline, week 12, week 24|Parathyroid hormone, Changes of parathyroid hormone at week 24, Baseline, week 12, week 24|25-hydroxyvitamin D, Changes of 25-hydroxyvitamin D at week 24, Baseline, week 12, week 24
Sponsor/Collaborators: Sponsor: Seoul National University Bundang Hospital | Collaborators: Astellas Pharma Korea, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 170
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-04-25
Completion Date: 2022-08-31
Results First Posted:
Last Update Posted: 2022-10-04
Locations: Seoul National University Bundang Hospital, Seongnam, Gyeonggi, 463-707, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03076112