A Long-term, Open-label Extension Study to Investigate the Long-term Safety of Alogliptin When Used in Combination With Sulfonylurea or 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
- 576
- 主要终点
- Number of Participants With Adverse Events.
研究概览
简要总结
To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).
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.
This was a phase 2/3, multicenter, open-label study, in participants who had completed the core phase 2/3 sulfonylurea add-on study (SYR-322/CCT-005; NCT01318083) or the core phase 2/3 metformin add-on study (SYR-322/CCT-006; NCT01318109) to evaluate the safety and efficacy of alogliptin administered as an add-on to a sulfonylurea (glimepiride) or metformin continuously for 40 weeks (52 weeks from the start of study treatment with alogliptin in the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
- •Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
- •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
- •Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
- •With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
- •With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
- •With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).
- •Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:
- •With history or symptoms of lactic acidosis.
研究组 & 干预措施
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
干预措施: Alogliptin and glimepiride (Drug)
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
干预措施: Alogliptin and glimepiride (Drug)
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
干预措施: Alogliptin and metformin (Drug)
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID
干预措施: Alogliptin and metformin (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 defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment 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 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 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 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 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 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).)