CTRI/2008/091/000031已完成2 期
A dose finding trial establishing efficacy and safety of NN9535 in comparison with placebo and liraglutide in type 2 diabetes
ovo Nordisk AS0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- •1. Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
- •2. Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
- •3. HbA1c: 7.0-10.0 % (both inclusive)
- •4. Body weight between 60 kg and 110 kg
- •5.Age 18 years and above
排除标准
- •1. Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months
- •2. Impaired liver or kidney function
- •3. Proliferative retinopathy or maculopathy requiring acute treatment
- •4. Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
- •5. Recurrent major hypoglycaemia or hypoglycaemic unawareness
- •6. Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)
研究者
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