NCT01511198已完成2 期
NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes
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
- 223
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic
- •Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed
- •Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive)
- •HbA1c maximum 10% based on analysis from central laboratory
排除标准
- •Cardiac problems
- •Uncontrolled treated/untreated hypertension
- •Proliferative retinopathy or known autonomic neuropathy
- •Recurrent severe hypoglycemia 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 investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
- •Known or suspected abuse of alcohol or narcotics
- •Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
- •TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL
- •Type 1 or other specific causes of diabetes
研究组 & 干预措施
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)
Met
Active Comparator
干预措施: metformin (Drug)
结局指标
主要结局
Body weight
次要结局
- FPG (fasting plasma glucose)
- HbA1c (glycosylated haemoglobin)
- Adverse events
- Fructosamine
- Lipids
研究者
研究点 (1)
Loading locations...
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