Dapagliflozin improves glycemic variability in subjects with type 2 diabetes mellitus when added to insulin therapy. The primary objective of this study is to assess the effect of dapagliflozin on glucose variability compared to placebo after 12 weeks of treatment in type 2 diabetic patients with inadequate glycemic control on insulin.
This study is a multicenter, randomized, double-blind, placebo-controlled phase 4 study to evaluate whether treatment with dapagliflozin add-on to insulin reduces glucose variability in type 2 Diabetes Mellitus. The study will recruit type 2 Diabetes Mellitus patients with inadequate glucose control on insulin treatment with or without metformin or sulphonylurea. It is estimated that 90 type 2 diabetic patients will be enrolled. After randomization, a total 12 week treatment of dapagliflozin or matching placebo will be administered. Before and after treatment, tests for efficacy and safety outcomes will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
86
Seoul St.Mary's Hospital
Seoul, South Korea
Glycemic Variability (mean amplitude of glycemic excursion)
MAGE(mean amplitude of glycemic excursion)
Time frame: baseline and 12 weeks
Glycemic Variability (Coefficient of Variation)
CV (Coefficient of Variation)
Time frame: baseline and 12 weeks
Glycemic Variability (Standard Deviation)
SD (Standard Deviation)
Time frame: baseline and 12 weeks
glycemic control variables HbA1C
HbA1C
Time frame: baseline and each visit(6weeks, 12weeks)
glycemic control variables Fasting Plasma Glucose
Fasting Plasma Glucose
Time frame: baseline and each visit(6weeks, 12weeks)
lipid profile Total cholesterol
Total cholesterol
Time frame: baseline and each visit(6weeks, 12weeks)
lipid profile Triglyceride
Triglyceride
Time frame: baseline and each visit(6weeks, 12weeks)
lipid profile HDL-cholesterol
HDL-cholesterol
Time frame: baseline and each visit(6weeks, 12weeks)
lipid profile LDL-cholesterol
LDL-cholesterol
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Time frame: baseline and each visit(6weeks, 12weeks)
glycemic control variables Percentage of patients achieving HbA1c < 7%
Percentage of patients achieving HbA1c \< 7%
Time frame: 12weeks
glycemic control variables Percentage of patients achieving HbA1c < 6.5%
Percentage of patients achieving HbA1c \< 6.5%
Time frame: 12weeks
glycemic control variables 24hr urinary glucose excretion
24hr urinary glucose excretion
Time frame: baseline and 12weeks
glycemic control variables Changes in insulin dose
Changes in insulin dose
Time frame: baseline and each visit(6weeks, 12weeks)
blood pressure SBP
SBP
Time frame: baseline and each visit(6weeks, 12weeks)
blood pressure DBP
DBP
Time frame: baseline and each visit(6weeks, 12weeks)