An Extension Study of Protocol ALO-IIT(PEAK Study) to Examine the Long-term Efficacy and Safety of Metformin + Alogliptin + Pioglitazone Triple Combination Therapy in the Korean Type 2 Diabetes Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving HbA1c <7% after 36 month treatment
研究概览
简要总结
Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open label extension trial for 28 weeks followed by 2 year observational study.
详细描述
PEAK trial is now undergoing (Multicenter, randomized, double blind, three-arm parallel group study to evaluate efficacy and safety of Alogliptin and Pioglitazone combination therapy on glucose control in type 2 diabetes subjects who have inadequate control with Metformin monotherapy in Korea, Takeda No. ALO-IIT-012).
Duration of combination treatment is 24 week in the PEAK trial. Long-term efficacy and safety of alogliptin + pioglitazone + metformin combination therapy is not defined in Korea yet.
Thus, extension of the PEAK trial for the longer treatment upto 1 year has been planned.
PEAK trial will be followed by another 28 week open-label treatment of the same drug as initial randomization (total duration of treatment as randomized 52 week), and followed by 2 year of observation.
During observation period, any antidiabetic medication can be added/changed when HbA1c of the subject is off target 7% with clinician's clinical decision.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed "ALO-IIT-012(PEAK study)", without major protocol deviations.
- •Male, or female, 19 years to 75 years.
- •Female with childbearing potential who has a negative urine pregnancy test result at study start and willing to continue practice appropriate birth control during the entire duration of study
- •Subjects completed PEAK can be included within 30 days after End Of the Study
- •Subjects completed PEAK can be included if their treatment is the same as randomized even after 30 days of End Of the Study.
排除标准
- •eGFR(Epidermal growth factor receptor) < 50mL/min
- •AST(aspartate aminotransferase)/ALT(alanine aminotransaminase) >2.5 upper limit of normal
- •Pregnant or lactating women
- •Subject who the investigator deems inappropriate to participate in this study
- •Patients with a history of bladder cancer or patients with active bladder cancer
- •Patients with uninvestigated macroscopic hematuria
- •Patients with cardiac failure or a history of cardiac failure (New York Heart Association [NYHA] Stages 3 to 4)
- •Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, since this study drug contains lactose
研究组 & 干预措施
alogliptin+pioglitazone
A group who treat with alogliptin+pioglitazone: The Combination of Alogliptin 25 mg and pioglitazone 30 mg daily add on metformin for 28 week as extension and followed by 2 years of observation
干预措施: alogliptin+pioglitazone (Drug)
alogliptin
A group who treat with alogliptin: Alogliptin 25 mg daily add on metformin for for 28 week as extension and followed by 2 years of observation
干预措施: alogliptin (Drug)
pioglitazone
A group who treat with pioglitazone: Pioglitazone 30 mg daily add on metformin for for 28 week as extension and followed by 2 years of observation
干预措施: pioglitazone (Drug)
结局指标
主要结局
Proportion of subjects achieving HbA1c <7% after 36 month treatment
时间窗: 36 months after randomization
The proportion of subjects achieving HbA1c on target \< 7.0% after 36 month.
次要结局
- change of HOMA-beta(homeostasis model assessment of beta cell) from baseline to 36 month(baseline, 36 months)
- Proportion of subjects achieving HbA1c <7% after 12 month treatment(12 Months after randomization)
- Proportion of subjects achieving HbA1c <6.5% after 36 month treatment(36 Months after randomization)
- Change in glycated hemoglobin(HbA1c) from baseline to 12 month(baseline, 12 months)
- Change in HOMA-IR(homeostasis model assessment of insulin resistance) from baseline to 36 month(baseline, 36 months)
研究者
Kun-Ho Yoon
professor
The Catholic University of Korea