A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 in Subjects With Type 2 Diabetes in Japan
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (Week 12).
研究概览
简要总结
The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.
详细描述
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.
To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
- •A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
- •Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).
排除标准
- •Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Alogliptin 6.25 mg QD
干预措施: Alogliptin (Drug)
Alogliptin 12.5 mg QD
干预措施: Alogliptin (Drug)
Alogliptin 25 mg QD
干预措施: Alogliptin (Drug)
Alogliptin 50 mg QD
干预措施: Alogliptin (Drug)
Voglibose 0.2 mg TID
干预措施: Voglibose (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (Week 12).
时间窗: Baseline and Week 12.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.
次要结局
- Change From Baseline in Glycosylated Hemoglobin (Week 2).(Baseline and Week 2.)
- Change From Baseline in Glycosylated Hemoglobin (Week 4).(Baseline and Week 4.)
- Change From Baseline in Glycosylated Hemoglobin (Week 8).(Baseline and Week 8.)
- Change From Baseline in Fasting Plasma Glucose (Week 2).(Baseline and Week 2)
- Change From Baseline in Fasting Plasma Glucose (Week 4).(Baseline and Week 4.)
- Change From Baseline in Fasting Plasma Glucose (Week 8).(Baseline and Week 8.)
- Change From Baseline in Fasting Plasma Glucose (Week 12).(Baseline and Week 12.)
- Change From Baseline in Fasting C-peptide (Week 2).(Baseline and Week 2.)
- Change From Baseline in Fasting C-peptide (Week 4).(Baseline and Week 4.)
- Change From Baseline in Fasting C-peptide (Week 8).(Baseline and Week 8.)
- Change From Baseline in Fasting C-peptide (Week 12).(Baseline and Week 12.)
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).(Baseline and Week 12.)
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).(Baseline and Week 12.)
- Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).(Baseline and Week 12)
- Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).(Baseline and Week 12.)
- Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).(Baseline and Week 12)