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 Thiazolidine 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
- 339
- 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 efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD 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 pioglitazone in type 2 diabetic patients with uncontrolled blood glucose despite treatment with pioglitazone 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
- 33 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 weeks prior to the start of the treatment period (Week 0).
- •Had glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 14 weeks after the start of the observation period (Week -2).
- •Had HbA1c difference within 10.0%* at 10 weeks after the start of the observation period (Week -6) and 14 weeks after the start of the observation period (Week -2) from 10 weeks after the start of the observation period (Week -6) (*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 a diabetic medications other than pioglitazone within 16 weeks before the start of the treatment period (Week 0).
- •Had a history or symptoms of cardiac failure.
研究组 & 干预措施
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
干预措施: Alogliptin and pioglitazone (Drug)
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
干预措施: Alogliptin and pioglitazone (Drug)
Pioglitazone (15mg or 30mg ) QD
干预措施: Pioglitazone (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 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 Blood Glucose Measured by the Meal Tolerance Test (Week 12).(Baseline and Week 12.)