NCT01152242已完成1 期
A Two-Part Clinical Trial to Assess Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)
研究概览
简要总结
The purpose of this study is to evaluate whether the within-subject variation in duration of action and time-action profile of glargine measured by isoglycemic clamp will be below prespecified levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient is a male between 18 to 45 years of age (inclusive) at the prestudy (screening) visit
- •Patient has a clinical diagnosis of type 1 diabetes
- •Patient must have been treated with insulin since diagnosis and be on a stable dose of insulin
- •Patient has a Body Mass Index (BMI) of <=27 kg/m2 and >18 kg/m2
- •Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
- •Subject is a male between 18 to 45 years of age at the prestudy (screening) visit
- •Subject has a Body Mass Index (BMI) of <=25 kg/m^2
- •Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
排除标准
- •Patient has a history of stroke, chronic seizures, or major neurological disorder
- •Patient has currently active and untreated clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases
- •Patient has a history of hypertension requiring treatment
- •Patient has a history of neoplastic disease within the past 5 years
- •Patient is currently being treated with, or has a history of treatment with any oral antihyperglycemic agent
- •Patient has a history of significant multiple and/or severe allergies
- •Subject has a history of stroke, chronic seizures, or major neurological disorder
- •Subject has a history of hypertension requiring treatment
- •Subject has a history of neoplastic disease within the past 5 years
- •Subject has history of diabetes (Type 1, Type 2 or steroid-induced) or family history of diabetes mellitus
- •Subject has a history of hypersensitivity to glargine or any of its inactive ingredients
研究组 & 干预措施
Part 1
Active Comparator
Part I of the trial
干预措施: Isoglycemic Clamp (Drug)
Part 2
Active Comparator
Part II of the trial
干预措施: Isoglycemic Clamp (Drug)
结局指标
主要结局
Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)
时间窗: Baseline and 30 hours
Part II: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR (AUC of glucose infusion rate), GIRmax (maximum level of glucose infusion rate), over the duration of action of glargine
时间窗: Baseline and 30 hours
次要结局
- Part II: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)(Baseline and 30 hours)
- Part I: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR and GIRmax over the duration of action of glargine(Baseline and 30 hours)
研究者
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