NCT01509755已完成2 期
Dose-response Relationship of Five Dose Levels of NNC90-1170 and Placebo on Glycaemic Control in Type 2 Diabetic Patients Compared to OHA Treatment. A 12-week Multi-centre, Double-blind, Randomised, Parallel Group Trial With an Open Labelled OHA Arm
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- HbA1c (glycosylated haemoglobin)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to establish the dose response relationship on glycaemic control of five dose levels of NNC90-1170.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 diabetes
- •Duration of diabetes at least 3 months
- •Both diet treated and patients in therapy with OHA (oral hypoglycemic agents)
- •Body Mass Index maximum 40 kg/m^2
- •HbA1c based on analysis from central laboratory: Between 7.5-10.0%, both inclusive, for diet treated, or maximum 9.0% for OHA treated
排除标准
- •Liver or renal disease
- •Cardiac problems
- •Uncontrolled treated/untreated hypertension
- •Proliferative retinopathy
- •Recurrent severe hypoglycaemia as judged by the Investigator
- •Known or suspected allergy to trial product or related products
- •Use of any drug (except for OHAs) which in the Investigator's opinion could interfere with the blood glucose level
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
0.045 mg
Experimental
干预措施: liraglutide (Drug)
0.225 mg
Experimental
干预措施: liraglutide (Drug)
0.45 mg
Experimental
干预措施: liraglutide (Drug)
0.60 mg
Experimental
干预措施: liraglutide (Drug)
0.75 mg
Experimental
干预措施: liraglutide (Drug)
Glim
Active Comparator
干预措施: placebo (Drug)
Glim
Active Comparator
干预措施: glimepiride (Drug)
结局指标
主要结局
HbA1c (glycosylated haemoglobin)
次要结局
- Fasting plasma glucose
- Fructosamine
- 7-point blood glucose profile
- Adverse events
研究者
研究点 (1)
Loading locations...
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