NCT01720303已完成4 期
A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD 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
- None
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
- •HbA1c between 7.5 % and 13.0% (both inclusive)
- •Fasting C-peptide above or equal to 0.33 nmol/l
- •BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)
排除标准
- •Medical history of treatment with insulin within the last 6 months
- •Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)
研究组 & 干预措施
Rep + NPH
Experimental
干预措施: repaglinide (Drug)
Rep + NPH
Experimental
干预措施: isophane human insulin (Drug)
Premixed insulin/NPH
Active Comparator
干预措施: insulin (Drug)
结局指标
主要结局
Change in HbA1c
次要结局
- Change in FBG (Fasting Blood Glucose)
- Change in body weight
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs AloneDiabetesDiabetes Mellitus, Type 2NCT01215435Novo Nordisk A/S245
已完成
4 期
Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin TreatmentDiabetes Mellitus, Type 2DiabetesNCT01123980Novo Nordisk A/S521
已完成
3 期
Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2DiabetesNCT01562561Novo Nordisk A/S213
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
4 期
Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering DrugsDiabetesDiabetes Mellitus, Type 2NCT00819741Novo Nordisk A/S433