CTRI/2010/091/000022已完成3 期
A trial comparing efficacy and safety of NN5401 with insulin glargine, both in combination with oral antidiabetic drugs in subjects with type 2 diabetes (BOOST? : INTENSIFY BASAL)
ovo Nordisk AS0 个研究点目标入组 450 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Type 2 diabetes mellitus for at least 6 months
- •Ongoing daily treatment with a basal insulin (insulin detemir, insulin glargine, or insulin NPH) once daily for at least 3 months
- •Ongoing treatment with metformin with our without other OADs (oral anti-diabetic drugs) for at least 3 months
- •HbA1c 7.0 ? 10.0 % (both inclusive)
- •BMI (Body Mass Index) at most 40.0 kg/m2
- •Age 18 Years and older
排除标准
- •Treatment with other insulin regimens than those listed in key inclusion criterion within the last 3 months
- •Treatment with rosiglitazone, or GLP-1 receptor agonists within the last 3 months
- •Significant cardiovascular disease within the last 6 months
- •Uncontrolled treated/untreated severe hypertension
- •Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
- •Impaired liver or renal function
- •Cancer and medical history of cancer
研究者
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