A Long-Term, Open-Label Extension Study to Investigate the Long-Term 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
- 336
- 主要终点
- Number of Participants With Adverse Events.
研究概览
简要总结
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study.
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 were enrolled from a core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070).
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
- 33 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had completed the core phase 2/3 thiazolidine add on study.
- •The subject was capable of understanding and complying with protocol requirements.
- •Signed a written, informed consent form prior to the initiation of any study procedure.
排除标准
- •With clinical manifestation of hepatic impairment (e.g., an AST or ALT value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 thiazolidine add on study).
- •With clinical manifestation of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of the core phase 2/3 thiazolidine add on study).
- •With a history or symptoms of cardiac failure.
研究组 & 干预措施
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg 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)
结局指标
主要结局
Number of Participants With Adverse Events.
时间窗: 52 Weeks.
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
次要结局
- Change From Baseline in Glycosylated Hemoglobin (Week 36).(Baseline and Week 36.)
- Change From Baseline in Glycosylated Hemoglobin (Week 8).(Baseline and Week 8.)
- Change From Baseline in Glycosylated Hemoglobin (Week 12).(Baseline and Week 12.)
- Change From Baseline in Glycosylated Hemoglobin (Week 16).(Baseline and Week 16.)
- Change From Baseline in Glycosylated Hemoglobin (Week 20).(Baseline and Week 20.)
- Change From Baseline in Glycosylated Hemoglobin (Week 24).(Baseline and Week 24.)
- Change From Baseline in Glycosylated Hemoglobin (Week 28).(Baseline and Week 28.)
- Change From Baseline in Glycosylated Hemoglobin (Week 32).(Baseline and Week 32.)
- Change From Baseline in Glycosylated Hemoglobin (Week 40).(Baseline and Week 40.)
- Change From Baseline in Glycosylated Hemoglobin (Week 44).(Baseline and Week 44.)
- Change From Baseline in Glycosylated Hemoglobin (Week 48).(Baseline and Week 48.)
- Change From Baseline in Glycosylated Hemoglobin (Week 52).(Baseline and Week 52.)
- Change From Baseline in Glycosylated Hemoglobin (Final Visit).(Baseline and Final Visit (up to Week 52).)
- Change From Baseline in Fasting Blood Glucose (Week 8).(Baseline and Week 8.)
- Change From Baseline in Fasting Blood Glucose (Week 12).(Baseline and Week 12.)
- Change From Baseline in Fasting Blood Glucose (Week 16).(Baseline and Week 16.)
- Change From Baseline in Fasting Blood Glucose (Week 20).(Baseline and Week 20.)
- Change From Baseline in Fasting Blood Glucose (Week 24).(Baseline and Week 24.)
- Change From Baseline in Fasting Blood Glucose (Week 28).(Baseline and Week 28.)
- Change From Baseline in Fasting Blood Glucose (Week 32).(Baseline and Week 32.)
- Change From Baseline in Fasting Blood Glucose (Week 36).(Baseline and Week 36.)
- Change From Baseline in Fasting Blood Glucose (Week 40).(Baseline and Week 40.)
- Change From Baseline in Fasting Blood Glucose (Week 44).(Baseline and Week 44.)
- Change From Baseline in Fasting Blood Glucose (Week 48).(Baseline and Week 48.)
- Change From Baseline in Fasting Blood Glucose (Week 52).(Baseline and Week 52.)
- Change From Baseline in Fasting Blood Glucose (Final Visit).(Baseline and Final Visit (up to Week 52).)
- Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).(Baseline and Week 12.)
- Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).(Baseline and Week 24.)
- Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).(Baseline and Week 52.)
- Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).(Baseline and Final Visit (up to Week 52).)