NCT00491725已完成4 期
A Multi-centre, Single Armed, Open Labelled Trial to Study the Efficacy and Safety Profile of Repaglinide & Metformin Combination Therapy in Chinese Type 2 Diabetics
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for at least 12 weeks
- •HbA1c: 8.0-10.0%
- •Current treatment with OAD on monotheray or OAD on combination therapy
- •Body mass index (BMI): 21.0-35.0 kg/m2
排除标准
- •Known or suspected allergy to trial product(s) or related products
- •Recurrent major hypoglycaemia as judged by the Investigator
- •Uncontrolled hypertension
- •Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator
结局指标
主要结局
HbA1c
时间窗: after 18 weeks of treatment
次要结局
- Safety profile
- Post Prandial Plasma Glucose
- Fasting Plasma Glucose (FPG)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2NCT01892020Novo Nordisk A/S161
已完成
3 期
Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short StatureGrowth DisorderIdiopathic Short StatureNCT01778023Novo Nordisk A/S54
已完成
3 期
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone DeficiencyGrowth Hormone DisorderAdult Growth Hormone DeficiencyNCT03075644Novo Nordisk A/S62
已完成
2 期
Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic FeverAcquired Bleeding DisorderDengue Haemorrhagic FeverNCT01601613Novo Nordisk A/S28
已完成
不适用
A Study to Evaluate Safety and Effectiveness in Patients of All Age Groups Excluding Less Than 12 Months Old Infants With Diabetes Mellitus in Routine Clinical Practice in KoreaDiabetesNCT02779413Novo Nordisk A/S3,303