NCT01511185已完成1 期
NNC 90-1170 Mechanism of Action: A Double-blind, Randomized, Single-center, Placebo Controlled, Crossover Study to Examine Beta-cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- AUC (area under the curve) of Insulin Secretion Rate (ISR) over the 90-216 mg/dL glucose interval
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 assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose concentrations in subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Diagnosed with type 2 diabetes, either newly diagnosed with at least 2 months of diet or on OAD monotherapy for at least 3 months
- •Body Mass Index (BMI): 24-35 kg/m^2 inclusive
排除标准
- •SUBJECTS WITH TYPE 2 DIABETES
- •Receipt of any investigational drug within three months prior to this trial
- •Recurrent severe hypoglycemia as judged by the investigator
- •Cardiac disease
- •Use of any drug (except an OAD (oral anti-diabetic drug)) that in the investigator's opinion could interfere with the blood glucose level
- •Haemoglobin maximum 10 g/L
- •HbA1c above 12%
- •Loss of more than 400 mL blood during the 3 months prior to trial start
- •HEALTHY SUBJECTS
- •Receipt of any investigational drug within 3 months prior to this trial
- •Clinically relevant cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
- •Use of any drug that in the investigator's opinion could interfere with the blood glucose level
- •Haemoglobin max. 10 g/L
- •HbA1c at least 6%
研究组 & 干预措施
NNC 90-1170
Experimental
干预措施: liraglutide (Drug)
NNC 90-1170
Experimental
干预措施: placebo (Drug)
Placebo
Placebo Comparator
干预措施: liraglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
AUC (area under the curve) of Insulin Secretion Rate (ISR) over the 90-216 mg/dL glucose interval
次要结局
- Insulin Clearance
- AUC (area under the curve) of glucagon concentration over the 90-216 mg/dL glucose interval
- Slope of the mean ISR vs mean glucose
- NNC 90-1 170 plasma concentration
- Adverse events
研究者
研究点 (1)
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