A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Metformin 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
- 288
- 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 evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.
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.
The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to metformin in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin as well as diet and exercise therapies.
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
- 26 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
- •Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
- •Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
- •Was receiving specific diet and exercise (if any) therapies during the observation period.
排除标准
- •Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
- •With a history or symptoms of lactic acidosis.
研究组 & 干预措施
Alogliptin 12.5 mg QD and metformin 500mg BID or 750mg TID
干预措施: Alogliptin and metformin (Drug)
Alogliptin 25mg QD and metformin 500mg BID or 750mg TID
干预措施: Alogliptin and metformin (Drug)
Metformin 500mg BID or 750mg TID
干预措施: Metformin (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 Fasting Plasma Glucose (Week 4).(Baseline and Week 4.)
- 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 8).(Baseline and Week 8.)
- Change From Baseline in Fasting Plasma Glucose (Week 12).(Baseline and Week 12.)
- Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).(Baseline and Week 12.)