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Clinical Trial Details

Trial ID: L3434
Source ID: NCT03202563
Associated Drug: Gemigliptin 50mg
Title: Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin Compared With Dapagliflozin Added on Metformin Alone or Diabetes Medication Naïve Patient in Type 2 Diabetes Mellitus (Stable II Study)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Gemigliptin 50mg|DRUG: Dapagliflozin 10mg|PROCEDURE: Diet/exercise questionnaire|DEVICE: Continuous Glucose Monitoring System(CGMS)|DRUG: Metformin
Outcome Measures: Primary: Changes from baseline MAGE(Mean amplitude of glycemic excursion) at week 12, MAGE will be calculated from MBG which has been measured by CGMS(Continuous Glucose Monitoring System) during CGM period(visit 2\~visit 3, visit 5\~visit 6), baseline (visit 2~visit3) and week 12 (visit 5~visit 6) | Secondary: Changes from baseline MBG(Mean Blood Glucose) at week 12, MBG is a mean blood glucose measured by CGMS(Continuous Glucose Monitoring System) during CGM period(visit 2\~visit 3, visit 5\~visit 6), baseline (visit 2~visit3) and week 12 (visit 5~visit 6)|Changes from baseline SD(Standard Deviation) at week 12, SD is a standard deviation of MBG measured by CGMS(Continuous Glucose Monitoring System) during CGM period(visit 2\~visit 3, visit 5\~visit 6), baseline (visit 2~visit3) and week 12 (visit 5~visit 6)|Changes from baseline CV(Coefficient of variance) at week 12, CV is a coefficient of variance which is MBG divided by SD measured by MBG during CGM period(visit 2\~visit 3, visit 5\~visit 6), baseline (visit 2~visit3) and week 12 (visit 5~visit 6)|Changes from baseline hsCRP at week 12, baseline (visit 2) and week 12 (visit 5)|Changes from baseline Nitrotyrosine at week 12, baseline (visit 2) and week 12 (visit 5) | Other: Changes of HbA1c at each visit, values of parameters at the corresponding visit - values of parameters at visit 2(baseline), baseline(visit 2), week 5(visit 4), week 13(visit 5)|Changes of Fasting plasma glucose at each visit, values of parameters at the corresponding visit - values of parameters at visit 2(baseline), baseline(visit 2), week 5(visit 4), week 13(visit 5)|Changes of Fasting serum insulin at each visit, values of parameters at the corresponding visit - values of parameters at visit 2(baseline), baseline(visit 2), week 5(visit 4), week 13(visit 5)|Changes of Glycated albumine at each visit, values of parameters at the corresponding visit - values of parameters at visit 2(baseline), baseline(visit 2), week 5(visit 4), week 13(visit 5)|Changes of baseline HOMA-β at week 13, baseline(visit 2), week 13(visit 5)|Changes of baseline HOMA-IR at week 13, baseline(visit 2), week 13(visit 5)|Changes of baseline LDL-C at week 13, baseline(visit 2), week 13(visit 5)|Changes of baseline HDL-C at week 13, baseline(visit 2), week 13(visit 5)|Changes of baseline Total Cholesterol at week 13, baseline(visit 2), week 13(visit 5)|Changes of baselineTriglyceride at week 13, baseline(visit 2), week 13(visit 5)|Changes of baseline BMI at week 13, baseline(visit 2), week 13(visit 5)|Changes of baseline Body weight at week 13, baseline(visit 2), week 13(visit 5)
Sponsor/Collaborators: Sponsor: LG Chem
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 71
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-08-09
Completion Date: 2018-12-07
Results First Posted:
Last Update Posted: 2019-02-15
Locations: Samsung Medical Center, Seoul, 06351, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03202563