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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Glycemic Variability (Coefficient of Variation)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •On weight loss program or taking weight loss medication
- •NYHA class III, IV congestive heart failure
- •History of acute myocardial infarction, unstable angina, coronary artery bypass graft or stroke within 6 months
- •History of bladder cancer
- •History of malignancy within 5 years
- •Pregnant or lactating women
- •History of excessive alcohol abuse (≥30g/day)
- •Hypersensitivity to SGLT2 inhibitors
- •Patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- •Subject who the investigator deems inappropriate to participate in this study
研究组 & 干预措施
dapagliflozin 10mg
a group which treated with dapagliflozin 10mg plus basal insulin therapy
干预措施: Dapagliflozin (Drug)
placebo 10mg
a group which treated with dapagliflozin placebo plus basal insulin therapy
干预措施: Placebo (Drug)
结局指标
主要结局
Glycemic Variability (Coefficient of Variation)
时间窗: baseline and 12 weeks
CV (Coefficient of Variation)
Glycemic Variability (Standard Deviation)
时间窗: baseline and 12 weeks
SD (Standard Deviation)
Glycemic Variability (mean amplitude of glycemic excursion)
时间窗: baseline and 12 weeks
MAGE(mean amplitude of glycemic excursion)
次要结局
- 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))
研究者
Kun-Ho Yoon
Professor of endocrinology division, Department of Internal Medicine
The Catholic University of Korea