NCT00264901已完成4 期
Impact of a Self-Adjusted Titration Guideline in Subjects With Type 2 Diabetes Mellitus: A Treat-to-Target of the Efficacy and Safety of Levemir® (Insulin Detemir [rDNA Origin] Injection) (PREDICTIVE™ 303)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5,652
- 试验地点
- 2
- 主要终点
- Comparison of the change from baseline to end of treatment
研究概览
简要总结
This trial is conducted in the United States of America (USA). This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician guided titration according to the local standard of care.
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
- •Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months;
- •BMI <= 45.0 kg/m2
- •Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator
排除标准
- •Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.
- •Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months.
- •Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues
- •Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator
结局指标
主要结局
Comparison of the change from baseline to end of treatment
时间窗: after 26 weeks in the value of laboratory-measured HbA1c between the self adjustment versus the standard of care group
次要结局
- Spontaneously reported adverse events during the trial
- Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am)
- FPG during the trial (central laboratory) at Visit 2 and Visit 3
- Proportion of subjects achieving HbA1C <= 7.0% at Visit 2 and Visit 3
- Insulin detemir doses at Visit 2 and Visit 3
- Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3
研究者
研究点 (2)
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