Effect of Dapagliflozin on Glycemic Variability as an add-on Therapy in Subjects With Type 2 Diabetes Mellitus With in Inadequate Glycemic Control in Insulin: a Multicenter, Placebo-controlled, Double-blind, Randomized Study
Overview
- Phase
- Phase 4
- Intervention
- Dapagliflozin
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- The Catholic University of Korea
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Glycemic Variability (Coefficient of Variation)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Kun-Ho Yoon
Professor of endocrinology division, Department of Internal Medicine
The Catholic University of Korea
Eligibility Criteria
Inclusion Criteria
- •Female and male aged 20\~70 years
- •Type 2 diabetes patients
- •Treatment on basal insulin therapy ≥0.2U/kg/day(±metformin and/or ±sulfonylurea) for at least 12 weeks
- •Inadequate glycemic control ; HbA1c 7.0%\~10.0% at screening
- •Female of childbearing potential agrees to routinely use of adequate contraception from signing of the informed consent throughout the duration of the study
- •Understands the study procedure, alternatives, and risks and voluntarily agrees to participated by giving written informed consent
Exclusion Criteria
- •Type 1 diabetes(Fasting C-peptide ≤ 0.78ng/dL(or 0.26 nM/L)), secondary diabetes, gestational diabetes
- •Insulin therapy modalities containing short or rapid acting insulin (continuous subcutaneous insulin injection, pre-mixed insulin, basal-bolus insulin)
- •History of diabetic ketoacidosis, hyperglycemic hyperosmolar state
- •Estimated glomerular filtration rate \<60 mL/min/1.73 m2
- •History of chronic cystitis or recurrent urinary tract infection
- •Currently on loop diuretics
- •Adrenal insufficiency, pituitary insufficiency
- •Currently on medication known to affect glucose metabolism (e.g. corticosteroids, immunosuppressants)
- •Hemoglobin \<10g/dL in female, \<12g/dL in male
- •Abnormal liver function (AST/ALT \> x3 upper normal limit)
Arms & Interventions
dapagliflozin 10mg
a group which treated with dapagliflozin 10mg plus basal insulin therapy
Intervention: Dapagliflozin
placebo 10mg
a group which treated with dapagliflozin placebo plus basal insulin therapy
Intervention: Placebo
Outcomes
Primary Outcomes
Glycemic Variability (Coefficient of Variation)
Time Frame: baseline and 12 weeks
CV (Coefficient of Variation)
Glycemic Variability (Standard Deviation)
Time Frame: baseline and 12 weeks
SD (Standard Deviation)
Glycemic Variability (mean amplitude of glycemic excursion)
Time Frame: baseline and 12 weeks
MAGE(mean amplitude of glycemic excursion)
Secondary Outcomes
- glycemic control variables Fasting Plasma Glucose(baseline and each visit(6weeks, 12weeks))
- lipid profile Triglyceride(baseline and each visit(6weeks, 12weeks))
- lipid profile LDL-cholesterol(baseline and each visit(6weeks, 12weeks))
- glycemic control variables Percentage of patients achieving HbA1c < 6.5%(12weeks)
- glycemic control variables HbA1C(baseline and each visit(6weeks, 12weeks))
- lipid profile Total cholesterol(baseline and each visit(6weeks, 12weeks))
- glycemic control variables 24hr urinary glucose excretion(baseline and 12weeks)
- lipid profile HDL-cholesterol(baseline and each visit(6weeks, 12weeks))
- glycemic control variables Percentage of patients achieving HbA1c < 7%(12weeks)
- glycemic control variables Changes in insulin dose(baseline and each visit(6weeks, 12weeks))
- blood pressure SBP(baseline and each visit(6weeks, 12weeks))
- blood pressure DBP(baseline and each visit(6weeks, 12weeks))