A Multi-center, Active Controlled, Randomized, Double-blinded, Parallel, Phase IV Study to Evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared With Sitagliptin in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Effect of Improving Glycemic Variability
研究概览
简要总结
An exploratory study to evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared with Sitagliptin in Patients with Type 2 Diabetes Mellitus
详细描述
This clinical trial is an exploratory study, and does not calculate the subject number based on statistical assumptions, and enrolls 50 subjects per group and a total of 100 subjects are registered to evaluate the effect of improving blood glucose variability in type 2 patients with anagliptin 100 mg twice a day(BID) and sitagliptin 100 mg once a day(QD).
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
- •Type 2 DM
- •Metformin monotherapy for more than 8 weeks and metformin ≥ 1000 mg daily for more than 8 weeks.
- •6.5% ≤HbA1c< 8.5%
- •Agreed Therapeutic Lifestyle change during the study period
- •Obtained Informed Consent Form
排除标准
- •Type 1 diabetes mellitus,
- •History of intestinal obstruction
- •NYHA class III to IV congestive heart failure,
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 X upper limit of normal (ULN) or Total bilirubin > 3 X ULN
- •Creatinine clearance (CrCl)* < 50 mL/min
- •Thyroid-stimulating hormone (TSH) ≥ 1.5 X ULN
- •Allergic history for Anagliptin 또는 sitagliptin
- •Being pregnant or nursing or suspected of being pregnant, or
- •History of participation in other clinical studies in the preceding 3 months.
研究组 & 干预措施
Anagliptin arm
Anagliptin 100 mg twice a day
干预措施: Anagliptin BID Treatment (Drug)
Sitagliptin 100mg
Sitagliptin 100mg once a day
干预措施: Anagliptin BID Treatment (Drug)
结局指标
主要结局
Effect of Improving Glycemic Variability
时间窗: 3 days after 12 weeks treatment
Mean amplitude of glycemic excursion (MAGE)
次要结局
- Average nighttime (18:00~07:59) blood glucose change after 12 weeks compared to baseline(after 12 weeks treatment)