A 16-week, Open-label, Multicentre, Randomised, Parallel Study to Evaluate Efficacy and Safety of Repaglinide and Metformin Combination Therapy Compared to Repaglinide Monotherapy in Chinese OAD Naive Type 2 Diabetic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 433
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin A1c (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 sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The associated unfavourable events including low blood sugar episodes between the two treatments are also compared.
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
- •Diagnosed with type 2 diabetes
- •Never taken oral antidiabetic drugs before
- •HbA1c greater than 8.5 %
- •BMI (Body Mass Index) less than or equal to 35 kg/m^2
排除标准
- •Known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications
- •Taken an investigational drug in another clinical trial within 4 weeks prior to this trial
- •Impaired liver function, defined as ASAT (aspartate aminotransferase) or ALAT (alanine aminotransferase) equal to or greater than 2 times upper normal limit
- •Have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems
- •Severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (BP) equal to or greater than 100 mmHg or systolic BP equal to or greater than 180 mmHg)
- •Impaired renal function
- •Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
- •Have a clinically significant, active cardiovascular disease, or decompensated heart failure
- •Treatment with systemic corticosteroids within the past two months prior to screening
研究组 & 干预措施
Repaglinide + metformin
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
干预措施: repaglinide (Drug)
Repaglinide + metformin
Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
干预措施: metformin (Drug)
Repaglinide
Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
干预措施: repaglinide (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin A1c (HbA1c)
时间窗: week -2 (screening), week 16
Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.
次要结局
- Change in 2-hour Postprandial Serum Insulin(Week 0, week 16)
- Change in Fasting Serum C-peptide(Week 0, week 16)
- Change in 2-hour Postprandial Serum C-peptide(Week 0, week 16)
- Hypoglycaemic Episodes(Weeks 0-16)
- Change in Blood Pressure(Week 0, week 16)
- Change in Fasting Plasma Glucose(week 0, week 16)
- Change in 2-hour Postprandial Plasma Glucose(Week 0, week 16)
- Change in 7-point Plasma Glucose Profile(Week 0, week 16)
- Change in Fasting Serum Insulin(Week 0, week 16)
- Physical Examinations(Week -2, week 16)
- ECG (ElectroCardioGram)(Week -2, week 16)
- Biochemistry: Alanine Aminotransferase (ALAT)(Week -2, week 16)
- Biochemistry: Alanine Aminotransferase (ASAT)(Week -2, week 16)
- Haematology: Haemoglobin(Week -2, week 16)