A Study to Observe the Progress of Diabetes Mellitus After 52 or 28 Weeks of HMS5552 Treatment for Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fasting glucose
研究概览
简要总结
At present, there are few studies on the clinical remission rate of diabetes after one year discontinuation of oral hypoglycemic drugs after intensive treatment. HMS5552 is a kind of GKA hypoglycemic drug. This study intends to observe the clinical remission rate of diabetes mellitus, beta cell function and blood sugar fluctuation of patients with type 2 diabetes mellitus who have been treated with HMS5552 for 52W or 28W and whose glucose control is up to the standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete HMS5552 treatment and safety visit;
- •HbA1c < 8.0% was detected in our laboratory;
- •Researchers judged the stability of glucose control based on the data of subjects'visits during HMS5552 treatment and the indicators of our hospital;
- •Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise;
- •Willing to sign written informed consent and abide by the research program.
排除标准
- •There was a state of illness in the subjects who could not complete the follow-up during the observation period.
- •The researchers judged that subjects'compliance with HMS5552 was affected during treatment.
研究组 & 干预措施
HMS5552 treatment
干预措施: HMS5552 (Drug)
结局指标
主要结局
Fasting glucose
时间窗: 4 weeks
Changes of fasting glucose
Postprandial glucose
时间窗: 4 weeks
Changes of postprandial glucose
C peptide
时间窗: 4-8 weeks
Changes of C peptide
HbA1c
时间窗: 4 weeks
Changes of HbA1c
次要结局
- 8-iso PGF2α(52 weeks)
- TNF-α(52 weeks)
- IL-6(52 weeks)
研究者
Majianhua
Director, Head of Endocrinology department, Clinical Professor
Nanjing First Hospital, Nanjing Medical University