NCT00521378已完成不适用
A Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients With Type 2 Diabetes Mellitus
Diasome Pharmaceuticals0 个研究点目标入组 6 人开始时间: 2007年9月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 主要终点
- Dose response of postprandial plasma glucose to escalated doses of oral HDV-insulin
研究概览
简要总结
A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must satisfy all of the following inclusion criteria to be included in the study:
- •be male or female between the ages of18 and 65 years, inclusive;
- •have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic agents for at least 3 months;
- •have a current physical examination that reveals no clinically significant abnormalities;
- •have no clinically significant abnormalities in vital signs;
- •have a body mass index (BMI) <38;
- •have a glycosylated hemoglobin (HbA1c) > 8 and <12;
- •have a C-peptide level >3 ng/mL;
- •have a typical fasting blood glucose levels of < 200 mg/dl (+/- 25 mg/dl);
- •be available for the entire study period, and be able and willing to adhere to protocol requirements;
- •if female of childbearing potential, must be using a reliable form of birth control; and,
- •provide written informed consent prior to admission into the study.
排除标准
- •have a history or presence of significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease, or conditions known to interfere with the absorption, distribution, metabolism, or excretion of insulin;
- •have a history of drug or alcohol dependency or psychological disease;
- •have any clinically significant illness during the 4 weeks prior to admission into the study;
- •require regular use of medication that interferes with the absorption and/or metabolism of insulin;
- •recent use (within 48 hours) of medications that interfere with blood glucose analyses, i.e., mannose, acetaminophen, dopamine, and ascorbic acid, which are all reported to alter glucose-oxidase type blood glucose analytical methods;
- •use of Avandia or Actos for treating diabetes;
- •participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study;
- •use of MAO inhibitors or enzyme-inducing or enzyme-inhibiting agents (eg, phenobarbital or carbamazepine) within 30 days prior to admission to this study;
- •are pregnant or lactating;
- •have an episode of severe hypoglycemia with seizure or coma within the past year;
- •have a history of ketoacidosis;
- •have any acute illness within 2 weeks prior to Screening; or,
- •have elevated liver enzymes (ALT, AST, alkaline phosphatase) >1.5 times the upper limit of normal.
结局指标
主要结局
Dose response of postprandial plasma glucose to escalated doses of oral HDV-insulin
时间窗: 3 weeks
To determine the dose response of postprandial plasma glucose to escalating doses (increased daily) of Oral HDV-Insulin given as single doses before breakfast, lunch and dinner, in addition to the Diabetes Mellitus (DM) subject's regular oral type 2 therapy
Daily glucodynamic profile of Oral HDV-Insulin
时间窗: 3 weeks
To compare the daily glucodynamic profile of Oral HDV-Insulin over the treatment days
次要结局
未报告次要终点
研究者
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