An Open-label Study to Assess the Safety and Tolerability of JANUVIA (Sitagliptin) in 30 Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment
研究概览
简要总结
This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with T2DM failing metformin monotherapy
- •Between the ages of 18 and 79
排除标准
- •Participants has a history of type 1 Diabetes Mellitus or ketoacidosis
研究组 & 干预措施
Sitagliptin
Sitagliptin as add-on therapy to a stable dose of metformin
干预措施: Sitagliptin phosphate (Drug)
Sitagliptin
Sitagliptin as add-on therapy to a stable dose of metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment
时间窗: 4 weeks
Safety \& tolerability were measured in terms of the # of participants with \>=1 adverse event (AE), \>=1 drug-related AE, \>=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.
次要结局
- Change From Baseline in Fasting Plasma Glucose at Week 4(Baseline and Week 4)