NCT06976658尚未招募2 期
Evaluating a Novel, Allosteric Glucokinase Activator in Monogenic Diabetes Secondary to Inactivating Glucokinase Mutations: a Randomised, Cross-over Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Fasting plasma glucose
研究概览
简要总结
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
详细描述
Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigators, outcome assessors
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and <75 years
- •body mass index (BMI) >18 and <30 kg/m2
- •fasting plasma glucose >5.6 mmol/L at screening
- •Participants with GCK-MODY had and are heterozygous carriers of a pathogenic or likely pathogenic GCK mutation at screening based on guidelines published by the American College of Medical Genetics and Genomics (ACMG), Association for Clinical Genomic Science (ACGS) and the ClinGen Monogenic Diabetes Expert Panel (MDEP) .
排除标准
- •Body weight <45kg at screening
- •Current or planning pregnancy or lactating
- •troke or cardiovascular disease within 6 months of recruitment
- •severe renal dysfunction (estimated glomerular filtration rate <30mL/min/1.73m2 or renal replacement therapy)
- •severe hepatic dysfunction (aspartate transaminase and/or alanine transaminase > 3 times upper limit of normal)
- •history of drug abuse or excessive alcohol intake
- •severe hypoglycemia within 6 months prior to screening
- •anaemia with Hb <10 g/dL at screening
- •excessive blood loss >300mL within 1 month of screening
- •use of strong or moderate CYP3A4 inhibitors or inducers
- •use of sulfonylureas, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 agonists, sodium glucose transporter 2 inhibitors, insulin, thiazolidinediones, acarbose in the 6 weeks prior to randomisation
- •use of long-term high-dose corticosteroids at randomisation
- •serious concurrent infections at time of screening
研究组 & 干预措施
Intervention
Active Comparator
active drug or placebo in a cross over randomised sequence
干预措施: Dorzagliatin (Drug)
placebo
Placebo Comparator
placebo in a cross over randomised sequence
干预措施: matched placebo (Drug)
结局指标
主要结局
Fasting plasma glucose
时间窗: 8 weeks
Difference in fasting plasma glucose (FPG) between treatment periods
次要结局
- • HbA1c(8 weeks)
- CGM metrics time in range(8 weeks)
- CGM metric coefficient of variation(8 weeks)
- Glucose area under the curve during OGTT(8 weeks)
- Insulin area under the curve during OGTT(8 weeks)
- GLP1 area under the curve during OGTT(8 weeks)
研究者
Elaine Chow
Associate Professor
Chinese University of Hong Kong
研究点 (1)
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