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临床试验/NCT02500186
NCT02500186已完成不适用

The Clinical Study to Assess the Effect of the Amount of Carbohydrate Intake and Meals Differing in Glycemic Index (GI) in Patients Treated With a Sodium-dependent Glucose Cotransporter 2 (SGLT2) Inhibitor

Kansai Electric Power Hospital0 个研究点目标入组 24 人开始时间: 2015年5月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
24
主要终点
Change in blood glucose level using CGM
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objectives of this clinical study is to assess the effect of the amount of carbohydrate intake and meals differing in glycemic index (GI) in patients of type 2 diabetes mellitus treated with an SGLT2 inhibitor (Luseogliflozin), which inhibits glucose reabsorption from renal uriniferous tubule, on glucose variability by using continuous glucose monitoring (CGM), and to establish dietary therapy which reduces the risk of hypoglycemia in patients treated with SGLT2 inhibitors. In addition, blood and urine samples are collected for metabolome analysis that will be performed as an extension study of the clinical study.

详细描述

<Background and Rationale> In order to decrease the risk of hypoglycemia caused by SGLT2 inhibitor, it is necessary to review the effect of the volume of carbohydrate intake and the level of GI value on variation of blood glucose.

Also, if a patient with chronic lack of carbohydrate intake receives SGLT2 inhibitors, there is a risk of serious hypoglycemic reaction. Thus, the establishment of proper meal for patients receiving SGLT2 inhibitors is the urgent task.

The objective of this study is to establish a safe dietary therapy for patients with type 2 diabetes mellitus to avoid hypoglycemia by controlling carbohydrate intake volume and GI value, where study patients are provided study meal three times a day and circadian blood glucose variation including blood glucose after meal is measured by using CGM.

In addition, blood and urine samples are collected for the future research (metabolome analysis) on the effect of carbohydrate intake volume and GI value on metabolism to be conducted as an extended study of this study.

<Study Procedures> Total of 24 study patients with type 2 diabetes mellitus who have not taken or washed out hypoglycemic drug (oral hypoglycemic drug and glucagon like peptide-1 receptor agonist) for at least 4 weeks are randomized into 3 groups (8 patients each) of high GI meal containing 55% carbohydrate group, low GI meal containing 55% carbohydrate group, and high GI meal containing 40% carbohydrate group. The energy intake of study patients in all the groups is 1800 kcal per day. Each study group patient takes the following diets for 14 days; study patients in high GI meal containing 55% carbohydrate group take 55% carbohydrate white rice diet; those in low GI meal containing 55% carbohydrate group take 55% carbohydrate brown rice diet; those in high GI meal containing 40% carbohydrate group take 40% carbohydrate white rice diet. Study patients orally receive luseogliflozin 2.5 mg s.i.d. before breakfast for 7 days from the 8th day of starting the study meal to the 14th day.

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
None

入排标准

年龄范围
20 Years 至 64 Years（Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Japanese patients with type 2 diabetes
  • •Patients aged 20 to 64, inclusive, when obtaining written informed consent, regardless of sex
  • •Patients with HbA1c (NGSP) between 7.0 and 10.0 % at screening examination or patients with HbA1c (NGSP) <= 10.0 % (no lower limit) at screening examination if they receive one kind of hypoglycemic drug (oral hypoglycemic drug or GLP-1 receptor agonist)
  • •Patients with BMI >= 20 kg/m2 and < 30 kg/m2
  • •Outpatients
  • •Patients who was explained about the clinical study, understood the content of the study, and gave written informed consent before participating in the clinical study

排除标准

  • •Patients who are diagnosed as diabetes mellitus other than type 2 diabetes, e.g., type 1 diabetes, diabetes with specific mechanism or disease except for type 2 diabetes, pregnancy diabetes
  • •Patients with complication of severe kidney dysfunction, e.g., nephrotic syndrome, renal failure, dialytic therapy
  • •Patients with eGFR < 45mL/min/1.73m2 at screening examination
  • •Patients with complication of severe hepatic disorder, e.g., hepatocirrhosis
  • •Patients with complication of severe heart disease, e.g., cardiac infarction, cardiac failure, or of cerebral infarction, or patients with medical history of those within 6 months prior to the initiation of the clinical study (obtaining informed consent)
  • •Patients who have serious complication of gastrointestinal disorders or who underwent a surgical operation that is known to affect the absorption of a drug by digestive tract
  • •Patients with diabetic microangiopathy, e.g., retinopathy of diabetes, diabetic neuropathy, or others which cannot be fully controlled regardless of continuing treatment
  • •Patients who are susceptible to dehydration (Patients with extremely poorly-controlled glycemia)
  • •Patients with complication of malignancy (Patients who recovered from malignancy are permitted to participate in the clinical study)
  • •Patients with a history of hypersensitivity to Luseogliflozin
  • •Patients who is a chronic heavy drinker
  • •Female patients who are pregnant, possibly pregnant, or breast-feeding
  • •Other patients who are judged as ineligible for enrollment in the clinical study by the principal investigator or subinvestigat or subinvestigator.

研究组 & 干预措施

High GI meal containing 55% carbohydrate

Experimental

The energy intake of study patients is 1800 kcal per day. Study patients in high GI meal containing 55% carbohydrate group take 55% carbohydrate white rice diet.

干预措施: Luseogliflozin (Drug)

High GI meal containing 55% carbohydrate

Experimental

The energy intake of study patients is 1800 kcal per day. Study patients in high GI meal containing 55% carbohydrate group take 55% carbohydrate white rice diet.

干预措施: Meal containing different carbohydrate ratio and GI value (Other)

Low GI meal containing 55% carbohydrate

Experimental

The energy intake of study patients is 1800 kcal per day. Study patients in low GI meal containing 55% carbohydrate group take 55% carbohydrate brown rice diet

干预措施: Luseogliflozin (Drug)

Low GI meal containing 55% carbohydrate

Experimental

The energy intake of study patients is 1800 kcal per day. Study patients in low GI meal containing 55% carbohydrate group take 55% carbohydrate brown rice diet

干预措施: Meal containing different carbohydrate ratio and GI value (Other)

High GI meal containing 40% carbohydrate

Experimental

The energy intake of study patients is 1800 kcal per day. Study patients in high GI meal containing 40% carbohydrate group take 40% carbohydrate white rice diet.

干预措施: Luseogliflozin (Drug)

High GI meal containing 40% carbohydrate

Experimental

The energy intake of study patients is 1800 kcal per day. Study patients in high GI meal containing 40% carbohydrate group take 40% carbohydrate white rice diet.

干预措施: Meal containing different carbohydrate ratio and GI value (Other)

结局指标

主要结局

Change in blood glucose level using CGM

时间窗: From Day 6 to Day 7, and from Day 13 and Day 14

Early morning on 8th and 15th day after the initiation of test meal

次要结局

  • Change of Hematologic test (Ratio of lymphocyte) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Hematologic test (White blood cell) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Hematologic test (Ratio of monocyte) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Hematologic test (Hematocrit) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Hematologic test (Ratio of neutrophils) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Hematologic test (Ratio of eosinophils) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Alkaline phosphatase) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Creatine kinase) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Blood urea nitrogen) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Glucose) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Hematologic test (Hemoglobin) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Hematologic test (Blood platelet) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Low-density lipoprotein cholesterol) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Total bilirubin) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Aspartate aminotransferase) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (γ-glutamyltransferase) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Lipase) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Urinary acid) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Plasma fatty acid composition) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Total cholesterol) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (High-density lipoprotein cholesterol) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Triglyceride) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Albumin) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Lactase dehydrogenase) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Lactic acid) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Hemoglobin A1c) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (C-peptide) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Glucagon) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Cross-linked N-telopeptide of type 1 collagen) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Urinary Qualitative (Sugar) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Hematologic test (Ratio of basophils) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Alanine aminotransferase) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Amylase) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Ketone body) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Urinary Qualitative (Protein) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Adverse events(From screening examination to Day 15)
  • Change of Biochemical examination of blood (Natrium) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Kalium) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Chlorine) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Calcium) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Non-esterified fatty acid) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Bone alkaline phosphatase) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Urinary sediment (White blood cell) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Urinary sediment (Urine creatinine) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Urinary sediment (Urinary albumin) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Body temperature rate from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Pulse rate from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Creatinine) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Urinary Qualitative (Uric blood) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Urinary sediment (Red blood cell) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Blood pressure rate from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Insulin) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Biochemical examination of blood (Choline esterase) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Urinary Qualitative (Ketone body) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Urinary sediment (Squamous cell) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Urinary sediment (Transitional cell) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))
  • Change of Urinary sediment (Urinary cytology) from baseline (Day 1) to Day 15(On Day 1 (before the start of test meal), Day 8 (pre-dose), and Day 15 (post-dose))

研究者

申办方类型
Other
责任方
Sponsor

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