NCT06671340尚未招募不适用
Effects of Repeated Dose of Dorzagliatin on Insulin Secretion, Glucagon Release and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Elaine Chow
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute Insulin secretion
研究概览
简要总结
A total of 30 subjects will be recruited 15 with intermediate hyperglycemia and 15 in the tyep 2 diabetes group respectively. Eligible participants will undergo hyperglycemic-clamp/oral glucose tolerance at baseline and after 4 weeks of dorzagliatin treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged ≥ 18 years but < 70 years
- •Male or female
- •Body mass index of over 18 kg/m2 and < 35 kg/m2
- •Additional inclusion criteria for IH group
- •Fasting plasma glucose <7.0 mmol/L and HbA1c < 6.5%
- •1 hour plasma glucose ≥8.6 and <11.6 mmol/L on 75g oral glucose tolerance test (OGTT)
- •No use of glucose lowering drugs in past 6 months
- •Additional inclusion criteria for T2D group
- •HbA1c 6.5 to 10% at screening
- •On diet control, or stable dose of oral glucose lowering drugs metformin for at least 8 weeks
排除标准
- •Subjects who do not agree to participate in this study.
- •Country of birth is unknown.
- •Body weight less than 45kg.
- •Acute phase of cerebrovascular and cardiovascular diseases (within 6 months of recruitment).
- •Subjects with severe renal dysfunction as defined by eGFR <30 ml/min/1.73m2 or patients receiving renal dialysis (such as haemodialysis or continuous ambulatory peritoneal dialysis).
- •Severe hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times upper limit of normal.
- •Severe cardiovascular disease, history of stroke, heart failure (NYHA III or IV) or history of myocardial infarction within last 12 months.
- •History of drug abuse or excessive alcohol intake based on investigator judgment.
- •Dehydration, diarrhoea or vomiting at the time of recruitment.
- •Subjects with severe infection, in perioperative period or with serious injury at the time of recruitment.
- •Subjects with anaemia (Haemoglobin <9.0mg/dL).
- •Pregnant or lactating or intending to become pregnant within 30 days after last dose of study drug.
- •Participation in a clinical trial with investigational product within 30 days before enrolment.
- •Donation or loss of blood (excluding the volume of blood that will be drawn during screening procedures) as follows: ≥300 mL of blood within 30 days prior to study drug administration.
- •Subjects judged unsuitable for the study based on investigator judgment.
- •Use of strong or moderate CYP3A4 inhibitors or inducers and cannot be discontinued.
- •Unwilling or unable to follow protocol requirements.
研究组 & 干预措施
IH/T2D
Experimental
partipiants with intermediate hyperglycemia (IH) n=15 or T2D (n=15)
干预措施: Dorzagliatin (Drug)
结局指标
主要结局
Acute Insulin secretion
时间窗: At baseline and after 4 weeks of study drug treatment
Acute (first phase) insulin response (AIRg) to glucose will be calculated as the mean incremental responses above baseline (average of -20 and -10 and 0 minutes) to the samples drawn at 2, 4, 6, 8 and 10 minutes of the hyperglycemic clamp.
次要结局
- Second phase insulin secretion(At baseline and after 4 weeks of study drug treatment)
- Beta cell glucose sensitivity(At baseline and after 4 weeks of study drug treatment)
- Glucagon-like peptide -1 (GLP-1)(At baseline and after 4 weeks of study drug treatment)
- Glucagon(At baseline and after 4 weeks of study drug treatment)
- Incretin effect(At baseline and after 4 weeks of study drug treatment)
研究者
Elaine Chow
Clinical Associate Professor
Chinese University of Hong Kong
研究点 (1)
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