NCT02771093已完成4 期
An Exploratory Study to Evaluate the Effects of Trelagliptin and Alogliptin by CGM on Glucose Variability for One Week in Patients With Type 2 Diabetes Mellitus
Takeda0 个研究点目标入组 27 人开始时间: 2016年9月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 主要终点
- Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
研究概览
简要总结
This is a multi-center, randomized, open-label, parallel-group comparative, exploratory study to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or alogliptin administered at a dose of 25 mg once daily for 4 weeks on glycemic variation in patients with type 2 diabetes mellitus using continuous glucose monitoring (CGM).
详细描述
The purpose of this study is to evaluate the effect of trelagliptin administered orally at a dose of 100 mg once weekly or alogliptin administered orally at a dose of 25 mg once daily for 4 weeks on glycemic variation in an exploratory manner as a primary objective and to evaluate the effect of difference method of administration of Dipeptidyl-peptidase (DPP)-4 on glycemic variation as secondary objective.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
- •Participants who are able to sign and date the informed consent form and information sheet prior to the start of study procedures.
- •Participants diagnosed with type 2 diabetes mellitus.
- •Participants with a glycated hemoglobin (HbA1c) [National Glycohemoglobin Standardization Program (NGSP value)] value ≥ 6.5% and < 8.5% at the start of the observation period (Day -2).
- •Participants who experience a ≤ ±1.0% change in HbA1c (NGSP value) at the start of the observation period (Day -2) as compared with an HbA1c value obtained during the preceding 6 weeks.
- •Participants receiving stable dietetic therapy and exercise therapy (if performed) for ≥ 4 weeks before the start of the observation period.
- •Participants, who in the opinion of the principal investigator or the investigator, does not have to change (including discontinuation or interruption) 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors or add new HMG-CoA reductase inhibitors during treatment period.
- •Men or women aged 20 years or older at the time of informed consent.
排除标准
- •Participants who received anti-diabetic medications within 4 weeks prior to the start of the observation period.
- •Participants who have changed (including discontinuation or interruption) HMG-CoA reductase inhibitors or received new HMG-CoA reductase inhibitors ≤ 4 weeks before the start of the observation period.
- •Participants with clinically evident hepatic dysfunction (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5-fold the upper limit of normal at the start of the observation period [Day -2]).
- •Participants with moderate renal dysfunction, severe renal dysfunction or renal failure (e.g., creatinine clearance < 50 mL/min or serum creatinine > 1.4 mg/dL in men or > 1.2 mg/dL in women [equivalent to the creatinine clearance for persons aged 60 years with a body weight of 65 kg] at the start of the observation period [Day -2]).
- •Participants with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases.
- •Participants with a history of gastric or small intestinal resection.
- •Participants with proliferative diabetic retinopathy.
- •Participants warranting insulin therapy for glycemic control (e.g., participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, perioperative participants, or serious trauma).
- •Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
- •Participants who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2).
- •Participants with any malignant tumors.
- •Habitual drinkers whose average daily alcohol consumption is > 100 mL.
- •Participants who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert.
- •Participants anticipated to require any prohibited concomitant medications during the study period.
- •Participants who are day and night lifestyle reversal.
- •Participants participating in any other clinical studies at the time of informed consent for this study.
- •Pregnant women, nursing mothers, women who are possible pregnant, or women who plan to become pregnant.
- •Other participants who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator.
研究组 & 干预措施
Trelagliptin 100 mg group
Experimental
Trelagliptin 100 mg once weekly taken orally before breakfast
干预措施: Trelagliptin (Drug)
Alogliptin 25 mg group
Experimental
Alogliptin 25 mg once daily taken orally before breakfast
干预措施: Alogliptin (Drug)
结局指标
主要结局
Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
时间窗: Baseline, up to 28 days
Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 \[Day 22\] and Day 8 on Week 3 \[Day 28\]) of the treatment period, calculated from the value at the start of the observation period.
次要结局
- Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal(Baseline, up to 28 days)
- Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia)(Baseline, up to 28 days)
- Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal(Baseline, up to 28 days)
- Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal(Baseline, up to 28 days)
- Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)(Baseline, up to 28 days)
- Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)(Baseline, up to 28 days)
- Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)(Baseline, up to 28 days)
- Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)(Baseline, up to 28 days)
- Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia)(Baseline, up to 28 days)
- Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal(Baseline, up to 28 days)
- Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal(Baseline, up to 28 days)
- Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)(Baseline, up to 28 days)
- Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)(Baseline, up to 28 days)
- Change From Baseline in Mean 24-hour Blood Glucose Levels(Baseline, up to 28 days)
- Change From Baseline in Mean Nocturnal Blood Glucose Levels(Baseline, up to 28 days)
- Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal(Baseline, up to 28 days)
- Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)(Baseline, up to 28 days)
- Change From Baseline in Mean Daytime Blood Glucose Levels(Baseline, up to 28 days)
- Change From Baseline in AUC for Blood Glucose(Baseline, up to 28 days)
- Standard Deviation (SD) of 24-hour Blood Glucose Values(Baseline, up to 28 days)
- Changes From Baseline in the SD of Daytime Blood Glucose Values(Baseline, up to 28 days)
- Changes From Baseline in the SD of Nocturnal Blood Glucose Values(Baseline, up to 28 days)
- Number of Participants Reporting One or More Treatment-emergent Adverse Events(Up to 29 days)
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