NCT00572052已完成4 期
Comparison of Glycemic Control Achieved With a 31 Gauge x 6 mm NovoFine® Needle vs. a BD 29 Gauge x 12.7 mm Ultra-Fine® Needle in Subjects With Diabetes Mellitus and a BMI Exceeding 30 kg/m2: An Open Label, Randomized, Two-Period Crossover Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 6
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if a 31 gauge x 6 mm needle will provide comparable blood glucose control to the 29 gauge x 12.7 mm needle in obese subjects with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus
- •Current treatment with insulin or insulin analogues for the last 6 months
- •BMI greater than or equal to 30.0 kg/m2
- •Currently injecting in the thigh or abdomen
- •HbA1c below 10%
排除标准
- •Severe, uncontrolled hypertension
- •Self-mixing insulin
- •Unwillingness to monitor blood glucose
- •Pregnancy, breast-feeding, intention to become pregnant, or inadequate contraceptive measures
结局指标
主要结局
HbA1c
时间窗: after 12 weeks of treatment
次要结局
- Quality of Life
- Subject preference and handling
- Frequency of hypoglycaemic episodes
研究者
研究点 (6)
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