NCT01290575已完成1 期
Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-820132 in Subjects With Type 2 Diabetes Treated With Metformin Monotherapy.
Bristol-Myers Squibb5 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 5
- 主要终点
- Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
研究概览
简要总结
BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of multiple doses of the investigational new drug, as well as the amount of study drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.
详细描述
Study Classification: Safety, Pharmacokinetics/dynamics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile).
- •Diagnosis of type 2 diabetes treated with metformin monotherapy (at least 1500 mg/day for at least 6 months) on a stable regimen for at least 2 months.
- •Body Mass Index (BMI) of 18.5 to 40 kg/m
- •Fasting glucose in the range of 125-275 mg/dL.
- •Hemoglobin A1c (HbA1c) in the range of 7.0% -11.0%.
- •Fasting C-peptide > 1 ng/mL.
排除标准
- •Clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations, and any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, depression, or hypothyroidism.
- •History of diabetic ketoacidosis, hyperosmolar nonketotic syndrome, lactic acidosis, hypoglycemia (i.e., ≥ 1 self-reported episodes of hypoglycemia within the last 3 months or ≥ 2 self-reported episodes of hypoglycemia within the last 6 months), or hypoglycemia unawareness.
- •Any major surgery within 4 weeks of study drug administration.
- •Any gastrointestinal surgery that could impact upon the absorption of study drug.
- •Smoking more than 10 cigarettes per day.
- •Recent drug or alcohol abuse.
- •Women who are pregnant or breastfeeding.
- •Positive urine screen for drugs of abuse.
- •Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody.
研究组 & 干预措施
Arm 9 BMS-820132 or placebo
Active Comparator
干预措施: Placebo (Drug)
Arm 9 BMS-820132 or placebo
Active Comparator
干预措施: BMS-820132 (Drug)
Arm 1 BMS-820132 or placebo
Active Comparator
干预措施: Placebo (Drug)
Arm 2 BMS-820132 or placebo
Active Comparator
干预措施: Placebo (Drug)
Arm 1 BMS-820132 or placebo
Active Comparator
干预措施: BMS-820132 (Drug)
Arm 2 BMS-820132 or placebo
Active Comparator
干预措施: BMS-820132 (Drug)
Arm 3 BMS-820132 or placebo
Active Comparator
干预措施: Placebo (Drug)
Arm 3 BMS-820132 or placebo
Active Comparator
干预措施: BMS-820132 (Drug)
Arm 4 BMS-820132 or placebo
Active Comparator
干预措施: Placebo (Drug)
Arm 4 BMS-820132 or placebo
Active Comparator
干预措施: BMS-820132 (Drug)
Arm 5 BMS-820132 or placebo
Active Comparator
干预措施: Placebo (Drug)
Arm 5 BMS-820132 or placebo
Active Comparator
干预措施: BMS-820132 (Drug)
Arm 6 BMS-820132 or placebo
Active Comparator
干预措施: Placebo (Drug)
Arm 6 BMS-820132 or placebo
Active Comparator
干预措施: BMS-820132 (Drug)
Arm 7 BMS-820132 or placebo
Active Comparator
干预措施: Placebo (Drug)
Arm 7 BMS-820132 or placebo
Active Comparator
干预措施: BMS-820132 (Drug)
Arm 8 BMS-820132 or placebo
Active Comparator
干预措施: Placebo (Drug)
Arm 8 BMS-820132 or placebo
Active Comparator
干预措施: BMS-820132 (Drug)
结局指标
主要结局
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
时间窗: within 7 days after the final dose
次要结局
- Time of maximum observed plasma concentration (Tmax) of BMS-820132(Day 1 and Day 14)
- Maximum observed plasma concentration (Cmax) of BMS-820132(Day 1 and Day 14)
- AUC(0-24 h) and postprandial AUC(0-4h) for biomarkers of glucose homeostasis(Day -1, Day 1, Day 7 and Day 14)
- Trough observed plasma concentration (Cmin) of BMS-820132(Day 1 through Day 14 (selected days))
- Accumulation index (AI) of BMS-820132(Day 14)
- Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132(Day 1 and Day 14)
- Half life (T-Half) of BMS-820132(Day 14)
研究者
研究点 (5)
Loading locations...
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