NCT01487421已完成不适用
The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,134
- 主要终点
- HbA1c (glycosylated haemoglobin)
研究概览
简要总结
This study is conducted in Europe. The aim of this study is investigate the potential of a supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled patients with type 2 diabetes in a normal diabetes care setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •OAD monotherapy
- •OAD combination therapy
- •Therapy with OAD and basal insulin
- •Conventional insulin therapy with premixed insulin
排除标准
- 未提供
研究组 & 干预措施
SIT
干预措施: insulin aspart (Drug)
SIT
干预措施: insulin detemir (Drug)
结局指标
主要结局
HbA1c (glycosylated haemoglobin)
次要结局
- 2-hours postprandial blood glucose
- Weight development
- Fasting blood glucose (FBG)
- Hypoglycemia
- Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs)
研究者
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