A Multicentre, National, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
Primary Objective:
To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to metformin in terms of change in Hemoglobin A1c (HbA1c) reduction.
Secondary Objectives:
To compare the safety and tolerability of gemigliptin and vildagliptin:
- Number of patients who experience at least one episode of hypoglycemia.
- Number of patients experiencing adverse event (AE), serious adverse event (SAE).
- Assessment of patients compliance defined as number tablets returned by patients.
详细描述
The study consists of 2 weeks screening and 24 weeks of treatment (a total of 26 weeks).
The protocol includes a screening period of two weeks, after which they will be randomized to receive gemigliptin or vildagliptin.
Patients will be evaluated through 4 mandatory visits during the study. Visit 1: Week -2 (screening) Visit 2: Week 0 (randomization) Visit 3: Week 12 (efficacy and safety evaluation) Visit 4: Week 24 (efficacy and safety evaluation)
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gemigliptin
GEMIGLIPTIN LS15-0444 administered once a day for 24 weeks as add-on therapy to metformin
干预措施: GEMIGLIPTIN LS15-0444 (Drug)
Gemigliptin
GEMIGLIPTIN LS15-0444 administered once a day for 24 weeks as add-on therapy to metformin
干预措施: metformin (Drug)
Vildagliptin
Vildagliptin administered twice a day for 24 weeks as add-on therapy to metformin
干预措施: vildagliptin (Drug)
Vildagliptin
Vildagliptin administered twice a day for 24 weeks as add-on therapy to metformin
干预措施: metformin (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: Up to Week 24
次要结局
- Change from baseline in postprandial glucose(Up to Week 24)
- Number of episode of hypoglycemia (symptomatic, asymptomatic, severe hypoglycemia)(Up to Week 24)
- Change from baseline in fasting plasma glucose(Up to Week 24)
- Percentage of patients achieving HbA1c <7% and <6.5%(Up to Week 24)
- Change from baseline in body weight(Up to Week 24)
- Number of adverse events(Up to Week 24)
- Number of serious adverse events(Up to Week 24)
- Percentage of patients with at least one episode of hypoglycemia(Up to Week 24)