NCT01263496已完成2 期
A Long-term, Open-label Extension Study to Investigate the Long-term Safety of SYR-322 in Subjects With Type 2 Diabetes in Japan.
Takeda0 个研究点目标入组 438 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 438
- 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 SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging 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, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who had completed the phase 2 dose-ranging study SYR-322/CCT-001 (NCT01263470).
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
- 29 Years 至 87 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).
排除标准
- •Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
- •Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
研究组 & 干预措施
Alogliptin 6.25 mg QD
Experimental
干预措施: Alogliptin (Drug)
Alogliptin 12.5 mg QD
Experimental
干预措施: Alogliptin (Drug)
Alogliptin 25 mg QD
Experimental
干预措施: Alogliptin (Drug)
Alogliptin 50 mg QD
Experimental
干预措施: Alogliptin (Drug)
Voglibose 0.2-mg TID
Active Comparator
干预措施: Voglibose (Drug)
结局指标
主要结局
Number of Participants With Adverse Events.
时间窗: 52 Weeks.
A treatment-emergent adverse event (TEAE) is defined as an adverse event 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, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date \>30) will be listed, but not included in the summary tables below.
次要结局
- 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 36).(Baseline and Week 36.)
- 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 Plasma Glucose (Week 12).(Baseline and Week 12)
- Change From Baseline in Fasting Plasma Glucose (Week 16).(Baseline and Week 16.)
- Change From Baseline in Fasting Plasma Glucose (Week 20).(Baseline and Week 20.)
- Change From Baseline in Fasting Plasma Glucose (Week 24).(Baseline and Week 24.)
- Change From Baseline in Fasting Plasma Glucose (Week 28).(Baseline and Week 28.)
- Change From Baseline in Fasting Plasma Glucose (Week 32).(Baseline and Week 32.)
- Change From Baseline in Fasting Plasma Glucose (Week 36).(Baseline and Week 36.)
- Change From Baseline in Fasting Plasma Glucose (Week 40).(Baseline and Week 40.)
- Change From Baseline in Fasting Plasma Glucose (Week 44).(Baseline and Week 44.)
- Change From Baseline in Fasting Plasma Glucose (Week 48).(Baseline and Week 48.)
- Change From Baseline in Fasting Plasma Glucose (Week 52).(Baseline and Week 52.)
- Change From Baseline in Fasting Plasma Glucose (Final Visit).(Baseline and Final Visit (up to Week 52).)
- Change From Baseline in Fasting C-peptide (Week 12).(Baseline and Week 12.)
- Change From Baseline in Fasting C-peptide (Week 16).(Baseline and Week 16.)
- Change From Baseline in Fasting C-peptide (Week 20).(Baseline and Week 20.)
- Change From Baseline in Fasting C-peptide (Week 24).(Baseline and Week 24.)
- Change From Baseline in Fasting C-peptide (Week 28).(Baseline and Week 28.)
- Change From Baseline in Fasting C-peptide (Week 32).(Baseline and Week 32.)
- Change From Baseline in Fasting C-peptide (Week 36).(Baseline and Week 36.)
- Change From Baseline in Fasting C-peptide (Week 40).(Baseline and Week 40.)
- Change From Baseline in Fasting C-peptide (Week 44).(Baseline and Week 44.)
- Change From Baseline in Fasting C-peptide (Week 48).(Baseline and Week 48.)
- Change From Baseline in Fasting C-peptide (Week 52).(Baseline and Week 52.)
- Change From Baseline in Fasting C-peptide (Final Visit).(Baseline and Final Visit (up to Week 52).)
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).(Baseline and Week 12.)
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).(Baseline and Week 24.)
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).(Baseline and Week 52.)
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).(Baseline and Final Visit (up to Week 52).)
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).(Baseline and Week 12.)
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).(Baseline and Week 24.)
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).(Baseline and Week 52.)
- Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).(Baseline and Final Visit (up to Week 52).)
- Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).(Baseline and Week 12.)
- Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).(Baseline and Week 24.)
- Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).(Baseline and Week 52.)
- Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).(Baseline and Final Visit (up to Week 52).)
- Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).(Baseline and Week 12)
- Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).(Baseline and Week 24.)
- Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).(Baseline and Week 52.)
- Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).(Baseline and Final Visit (up to Week 52).)
- Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).(Baseline and Week 12)
- Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).(Baseline and Week 24.)
- Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).(Baseline and Week 52.)
- Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).(Baseline and Final Visit (up to Week 52).)
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