NCT01022762已完成4 期
A 16-week, Multicentre, Randomised, Open-label, Parallel Group Study to Investigate the Efficacy and Safety Profiles of Repaglinide Monotherapy Compared to Gliclazide Monotherapy in Chinese Antidiabetic-naïve Subjects With Type 2 Diabetes
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
- 440
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c)
研究概览
简要总结
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of repaglinide on the phases of insulin secretion as a subgroup study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed)
- •Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
- •Lipid-lowing agent naïve
- •HbA1c: 6.5-8.5%
- •Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl)
- •Body Mass Index (BMI): 20-35 kg/m^2
- •Be able and willing to perform self-monitored plasma glucose (SMPG)
- •Be able and willing to eat 3 main meals per day
- •Only applicable to subjects who will participate in the subgroup study: Be able and willing to perform and complete IVGTT (intravenous glucose tolerance test) at additional visits
排除标准
- •Known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the study drugs
- •Previous participation in this study
- •Participation in a study of another investigational drug within 1 month prior to study start
研究组 & 干预措施
repaglinide
Active Comparator
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
干预措施: repaglinide (Drug)
gliclazide
Active Comparator
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
干预措施: gliclazide (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c)
时间窗: Week 0, week 16
次要结局
- Change in AUC0-180 of Plasma Glucose Concentration of IVGTT(Over the course of three hours at Week 0 and Week 16)
- Change in Fasting Plasma Glucose(Week 0, week 16)
- Change in Fasting Serum Free Fatty Acid (FFA) From Baseline(Week 0, week 16)
- Change in Body Weight(Week 0, week 16)
- Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal(Week 0, week 16)
- Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test)(Over the course of three hours at Week 0 and Week 16)
- Number of All Treatment Emergent Hypoglycaemic Episodes(Weeks 0-16)
- Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%(Week 16)
- Cholesterol(Week 0, week 16)
- Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal(Week 0, week 16)
研究者
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