NCT01728467已完成2 期
Phase 2 Randomised, Double-blind, Placebo-controlled, Cross-over Study for the Assessment of Glucose Metabolism Changes With RVX000222 in Individuals With Pre-diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in plasma glucose following treatment with RVX000222 compared to placebo
研究概览
简要总结
This study builds on data that high-density lipoprotein (HDL) has a number of potentially beneficial effects including directly modulating glucose metabolism through multiple mechanisms. The primary objective of this study is to determine the effects of RVX000222 on postprandial plasma glucose in male individuals with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), during a frequently sampled oral glucose tolerance test (OGTT).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 18-70 years, inclusive
- •Body mass index (BMI): 25-40 kg/m2
- •HDL cholesterol plasma levels: ≤1.4 mmol/L
- •Pre-diabetes: Either impaired fasting glucose (IFG; 6.1-6.9mmol/L) or impaired glucose tolerance (IGT; 2 hour OGTT glucose 7.8-11.0mmol/L, WHO classification) as measured at Visit 1
- •No current use or need for prescription or over-the-counter medication within four days of Visit 1
- •Have given signed informed consent to participate in the study
排除标准
- •Identification of any other medical condition requiring immediate therapeutic intervention
- •Has received any over-the-counter medication including vitamins, herbal, or dietary supplements within four days of Visit 1 unless prior approval from the Investigator
- •Tobacco use within six months of Visit 1 (including cigarettes, pipes, chewing tobacco)
- •Elective surgery requiring general anaesthesia during the course of the study
- •Clinically significant heart disease at Visit 1
- •Clinically significant abnormal ECG at Visit 1
- •Evidence of renal impairment defined as serum creatinine >1.5 mg/dL (133 μmol/L) or creatinine clearance of <60 mL/min
- •History of hypertension or supine SBP >160mmHg or DBP >95mmHg as measured at Visit 1
- •Evidence of type 2 diabetes (fasting plasma glucose ≥7.0mmol/L; 2 hour OGTT glucose ≥11.1mmol/L)
- •Evidence of liver disease defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT) or total bilirubin >1.5 x upper limit of normal (ULN) at Visit 1
- •History of malignancy within past 5 years
- •History or evidence of drug or alcohol abuse within 12 months of Visit 1
- •Use of other investigational drugs and/or devices at the time of enrolment, or within 30 days of Visit 1
- •History of non-compliance to medical regimens or unwillingness to comply with the study protocol
- •Any condition that in the opinion of the Investigators would confound the evaluation and interpretation of the data
- •Persons directly involved in the execution of the protocol
研究组 & 干预措施
RVX000222, 200 mg daily
Experimental
干预措施: RVX000222 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo, RVX000222 (Drug)
结局指标
主要结局
Change in plasma glucose following treatment with RVX000222 compared to placebo
时间窗: 29-33 days
The change in postprandial plasma glucose, defined as area under the glucose curve (AUGC) during a frequently sampled OGTT following RVX000222 treatment for 29-33 days as compared to placebo.
次要结局
- Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo(29-33 days)
研究者
研究点 (1)
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