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Clinical Trial Details

Trial ID: L7189
Source ID: NCT02459353
Associated Drug: Dapagliflozin
Title: Effect of Dapagliflozin on Glycemic Variability
Acronym: DIVE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Dapagliflozin|DRUG: Placebo
Outcome Measures: Primary: Glycemic Variability (mean amplitude of glycemic excursion), MAGE(mean amplitude of glycemic excursion), baseline and 12 weeks|Glycemic Variability (Coefficient of Variation), CV (Coefficient of Variation), baseline and 12 weeks|Glycemic Variability (Standard Deviation), SD (Standard Deviation), baseline and 12 weeks | Secondary: glycemic control variables HbA1C, HbA1C, baseline and each visit(6weeks, 12weeks)|glycemic control variables Fasting Plasma Glucose, Fasting Plasma Glucose, baseline and each visit(6weeks, 12weeks)|lipid profile Total cholesterol, Total cholesterol, baseline and each visit(6weeks, 12weeks)|lipid profile Triglyceride, Triglyceride, baseline and each visit(6weeks, 12weeks)|lipid profile HDL-cholesterol, HDL-cholesterol, baseline and each visit(6weeks, 12weeks)|lipid profile LDL-cholesterol, LDL-cholesterol, baseline and each visit(6weeks, 12weeks)|glycemic control variables Percentage of patients achieving HbA1c < 7%, Percentage of patients achieving HbA1c \< 7%, 12weeks|glycemic control variables Percentage of patients achieving HbA1c < 6.5%, Percentage of patients achieving HbA1c \< 6.5%, 12weeks|glycemic control variables 24hr urinary glucose excretion, 24hr urinary glucose excretion, baseline and 12weeks|glycemic control variables Changes in insulin dose, Changes in insulin dose, baseline and each visit(6weeks, 12weeks)|blood pressure SBP, SBP, baseline and each visit(6weeks, 12weeks)|blood pressure DBP, DBP, baseline and each visit(6weeks, 12weeks)
Sponsor/Collaborators: Sponsor: The Catholic University of Korea | Collaborators: AstraZeneca|Severance Hospital|Eulji General Hospital|Kyung Hee University Hospital at Gangdong
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 86
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-08
Completion Date: 2017-05
Results First Posted:
Last Update Posted: 2017-07-13
Locations: Seoul St.Mary's Hospital, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02459353