NCT02470039已完成2 期
An 8-week Randomised, Double-blind, Parallel, Multiple Dose Trial Comparing NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy
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
- 50
- 试验地点
- 1
- 主要终点
- Change in fasting plasma glucose (FPG)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare NNC0123-0000-0338 (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral antidiabetic therapy
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-70 years (both inclusive) at the time of signing informed consent
- •Body mass index of 25.0-40.0 kg/m^2 (both inclusive)
- •Subject diagnosed (clinically) with type 2 diabetes mellitus for at least 180 days prior to the day of screening
- •Insulin naïve subject; however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
排除标准
- •Known or suspected hypersensitivity to the trial products or related products
- •Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- •Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
研究组 & 干预措施
Oral insulin 338 and subcutaneous placebo
Experimental
干预措施: insulin 338 (GIPET I) (Drug)
Oral insulin 338 and subcutaneous placebo
Experimental
干预措施: placebo (Drug)
Subcutaneous insulin glargine and oral placebo
Active Comparator
干预措施: insulin glargine (Drug)
Subcutaneous insulin glargine and oral placebo
Active Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in fasting plasma glucose (FPG)
时间窗: Week 0, Week 8
次要结局
- Change from baseline in 10-points plasma glucose profile(Week 0, Week 8)
- Number of treatment emergent hypoglycaemic episodes(From start of treatment until Visit 14 (Day 68))
- area under the serum insulin concentration-time curve(During one dosing interval (0 to 24 hours) at steady state (Day 56))
研究者
研究点 (1)
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