NCT02446028暂停2 期
A Randomized, Open-label Parallel Group Phase 2b Trial Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes
Biodel7 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 13
- 试验地点
- 7
- 主要终点
- Change in HbA1c
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of BIOD-531 compared to Humalog®Mix 75/25 in patients with type 2 diabetes.
详细描述
BIOD-531 is a formulation of recombinant human insulin with a biphasic absorption profile characterized by rapid absorption (to prevent meal-time rises in blood glucose) and a secondary longer (basal) phase. The purpose of this trial is to evaluate glucose control and safety of BIOD-531 compared to a pre-mixed insulin which is commonly used to provide both meal-time and long acting insulin.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established clinical diagnosis of type 2 diabetes, consistent with ADA classification criteria for 6 months or longer.
- •Body Mass Index 27 - 45 kg/square meter, inclusive.
- •Screening HbA1c between 7.5 and 11.0%, inclusive.
- •Up to two injections per day of U-100 basal (NPH, glargine, or detemir), pre-mixed, or self-mixed basal/prandial insulins or insulin analogs at stable total daily doses between 40 -200 units/day, inclusive, for ≥ 3 months prior to screening.
排除标准
- •Regular use of Humulin®R U-500 or sulfonylurea, exenatide (short-acting), repaglinide, or nateglinide within 1 month prior to screening.
- •History of bariatric surgery.
- •Subject has had one or more severe hypoglycemic episodes associated with seizure, coma, or unconsciousness within the past 6 months.
- •History of known hypersensitivity to any of the components in the study medication.
- •New York Heart Association (NYHA) Class III or IV functional capacity, unstable angina pectoris, myocardial infarction, severe peripheral vascular disease, ischemic strokes or transient ischemic attacks within 6 months of screening.
- •Systolic blood pressure ≥ 180 mmHg or sitting diastolic blood pressure ≥ 100 mmHg confirmed on repeat during screening visit.
研究组 & 干预措施
BIOD-531
Experimental
BIOD-531 injected twice daily
干预措施: BIOD-531 (Drug)
Humalog® Mix 75/25
Active Comparator
Humalog® Mix 75/25 injected twice daily
干预措施: Humalog® Mix 75/25 (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: 18 weeks
次要结局
- Change in weight(18 weeks)
- Hypoglycemic event rates(18 weeks)
- Postprandial glucose excursions(18 weeks)
研究者
研究点 (7)
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