NCT01686620已完成2 期
A Randomized, Parallel Group Trial Evaluating Safety and Efficacy of BIOD-123 Compared to Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes Using Basal-bolus Insulin Injection Therapy
Biodel33 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2012年8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
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 33
- 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-123 compared to insulin lispro (Humalog®) when used as part of a basal-bolus regimen in patients with type 1 diabetes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established clinical diagnosis of type 1 diabetes, consistent with ADA classification criteria (Diabetes Care 35: S64-S71, 2012), for more than 1 year.
- •Age: 18 years old, or older.
- •Body Mass Index: between 18 and 35 kg/m2, inclusive.
- •Willing to use insulin glargine as the only basal insulin throughout the duration of the trial.
- •Willingness not to use insulin pump treatment and only use the study glucose meter and CGM devices during the duration of the trial.
排除标准
- •History of known hypersensitivity to any of the components in the study medication
- •Treatment with pramlintide or GLP-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study.
- •Treatment with oral or intravenous corticosteroids in the last 3 months prior to screening. Standard doses of inhalational corticosteroid used as part of a long term treatment regimen are allowed.
- •Consistent recent hypoglycemic unawareness within the last six months
- •History of more than two severe hypoglycemic events within six months prior to screening
研究组 & 干预措施
BIOD-123
Experimental
BIOD-123 used as prandial insulin
干预措施: BIOD-123 (Drug)
Lispro (Humalog)
Active Comparator
Lispro (Humalog) used as prandial insulin
干预措施: Lispro (Humalog) (Drug)
结局指标
主要结局
Change in HbA1C
时间窗: Baseline and 18 week treatment period
次要结局
- Hypoglycemic event rates(Baseline and 18 week treatment period)
- Insulin dose(Baseline and 18 week treatment period)
- Daily blood glucose measures(Baseline and 18 week treatment period)
研究者
研究点 (33)
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