NCT04374578已完成不适用
Effect of Dulaglutide on Glycemic Variability in Patients With Type 2 Diabetes: A Multi-center Observational Study
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effect on glycemic variability
研究概览
简要总结
Glycemic variability will be assessed using continuous glucose monitor(CGM) in type 2 diabetic patients who receive dulaglutide 1.5 mg/qw injection for 4 weeks.
详细描述
Glycemic fluctuation is a major problem in glucose control in diabetic patients. It is interesting to know that whether weekly GLP-1RA can improve glycemic variability in diabetic patients. The present study aims to assess the effect of dulaglutide on glycemic variability using continuous glucose monitor(CGM) (Libra, Abbott) in type 2 diabetic patients with 4 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form;
- •Meet the World Health Organization(WHO) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes;
- •18 ≤ age ≤ 70 years old, male or female;
排除标准
- •Subjects with Type 1 diabetes mellitus or secondary diabetes mellitus (i.e. any type other than T2DM)
- •Personal history or family history of thyroid medullary carcinoma or multiple endocrine neoplasia type 2 (MEN2).
- •History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study (e.g. due to symptomatic gallstones).
- •History of significant gastrointestinal (GI) surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function.
- •Fasting triglyceride level more than 750 mg/dL at screening.
- •Estimated Glomerular Filtration Rate (eGFR) less than 60 mL/minute/1.73 meter^2 (calculated using the Schwartz equation) at screening.
- •ALT more than 2.5x upper limit of normal (ULN) or Bilirubin more than 1.5xULN (isolated bilirubin more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin more than 35%) at screening.
- •Use of a GLP-1receptor agonist at study entry and during the study.
结局指标
主要结局
Effect on glycemic variability
时间窗: one months
The FreeStyle Libre Pro (Abbott Co., Ltd) will be used to monitor glucose levels during the four weeks from the day before the first administration of the study drug
次要结局
- Effect on Glycemic Control(one months)
研究者
研究点 (1)
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