Effects of Dapagliflozin on Hyperlipidemia, Glycemic Control and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS Study)
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Changes in fasting lipoprotein profiles
研究概览
简要总结
The investigators will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus whose HbA1c levels are less than 7.0% (from 20 to 65 years of age). The investigators will examine changes of fasting lipoprotein profile including TG, TC, HDL-C, apoB-48 and RemL-C before and after the 8 weeks administration of dapagliflozin.
详细描述
In this study, the investigators will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus. Primary Objective is to examine changes of fasting lipoprotein profile by the administration of dapagliflozin; Concentrations of apoB-48 and RemL-C. Secondary Objectives are; to examine changes of fasting glucose and HbA1c (NGSP) level by the administration of dapagliflozin, to examine changes of fasting lipid profile by the administration of dapagliflozin; Concentrations of TG, TC, HDL-C and LDL-C, to examine changes of fractions of free fatty acids, protein mass of LPL, and lipoprotein profile assessed by the HPLC by the administration of dapagliflozin, to examine changes of biomarkers for renal and hepatic function by the administration of dapagliflozin, and to examine the frequency of adverse effects by the administration of dapagliflozin. This study is open-label study and contains patients who are diabetes mellitus of from 20 to 65 years of age and their Patients who have not achieve the clinical target of the glycemic control (less than 7.0% in HbA1c).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with type 2 diabetes mellitus of from 20 to 65 years of age.
- •Patients who have not achieve the clinical target of the glycemic control (less than 7.0% in HbA1c).
- •Patients who received the diet therapy, the exercise therapy or the following anti-diabetic drugs in addition to the diet and/or exercise therapy (up to two drugs) with dosage stable for 8 weeks prior to entry.
- •Sulfonylurea (Glymepiride 2mg/day or less, Glibenclamide 1.25mg/day or less, Gliclazide 40mg/day or less)
- •Thiazolidine (Actos)
- •Biguanide (Metformin, Buformin)
- •alpha-glucosidase inhibitor (Voglibose, Miglitol, Acarbose)
- •DPP4 inhibitors (Sitagliptin, Linagliptin, Anagliptin, Teneligliptin, Alogliptin, Saxagliptin)
- •Informed consent to participate in the study prior to any study procedures.
排除标准
- •Type 1 diabetes mellitus
- •Moderate or severe renal dysfunction (eGFR<45 ml/min/1.73m2 or hemodialysis)
- •Severe hepatic insufficiency (AST and/or ALT >3x upper limit of normal)
- •Adrenal insufficiency or pituitary gland dysfunction
- •Malnourishment, starvation, irregular dietary intake, poor dietary intake, debilitating condition or a severe muscle movement
- •Volume depleted patients; concomitant medication such as loop diuretics.
- •Excessive alcohol intake (>60g daily)
- •SGLT2 inhibitors such as dapagliflozin are already administered
- •Contraindication with dapagliflozin
- •Start a new medication of statins, fibrates, ezetimibe or probucol within a month
- •Females who are likely to be pregnant, during pregnancy or lactating
- •Participants in other clinical trials
- •Inability to communicate and comply with all study requirements.
研究组 & 干预措施
Dapagliflozin
Diabetic patients who met the inclusion/exclusion criteria. Dapagliflozin is orally administered for 8 weeks in the dose of 5mg per day if there is no serious event included in termination criteria. If the effect for improving diabetes is insufficient, it is allowed to raise its dose up to 10mg/day.
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Changes in fasting lipoprotein profiles
时间窗: at four and eight weeks after the administration of dapagliflozin
Changes in fasting lipoprotein profiles including concentrations of apoA-1, apoA-2, apoB, apoB-48, apoC-2, apoC-3, apoE, RemL-C, free-fatty acids profile, LPL protein mass and lipoprotein profile assessed by the HPLC at four and eight weeks after the administration of dapagliflozin
次要结局
- Changes in fasting blood glucose and HbA1c(at four and eight weeks after the administration of dapagliflozin)
- Changes in fasting lipid profiles(at four and eight weeks after the administration of dapagliflozin)
- Changes in insulin and adiponectin(at four and eight weeks after the administration of dapagliflozin)
- Frequency of adverse side effects(at four and eight weeks after the administration of dapagliflozin)
- Changes in biomarkers for renal and hepatic function(four and eight weeks after the administration of dapagliflozin.)