NCT01370707已完成3 期
A Randomized, Double-blind, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of CJ-30001 and CJ-30002 in Patients With Type 2 Diabetes and Inadequate Glycemic Control ; Phase III Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 21
- 主要终点
- Change from baseline in HbA1c at week 24
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety fo CJ-30001/CJ-30002.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Type 2 Diabetes Mellitus
- •20~69 years old
- •BMI < 30kg/m2
- •HbA1c between 7% and 11%
- •receiving no oral antihyperglycemic agent for more than seven days for at least 8 weeks
- •Willing to adhere to protocol requirements and sign a informed consent form
排除标准
- •Subjects with Type 1 Diabetes Mellitus
- •FPG > 270mg/dL
- •Subjects having insulin treatment
- •Subjects with acute or chornic metaboic acidosis
- •Subjects with cardiovascular disease
- •Subjects with chronic GI disease
- •Subjects with a history of substance or alchol abuse within 1 year
- •Subjects with a history of hypersensitivity to biguanide or a-GI
- •Subjects with hypopituitarism or hypocorticalism
- •Subjects with cancer
- •Subjects who take corticosteriods or plan to take corticosteroid
- •AST and ALT > 2.5 times the upper limit of normal
- •Creatinine level > 1.5mg/dL in male and 1.4mg/dL in female
- •SBP > 150mmHg or DBP > 90mmHg
- •Subjects who work the night shift
- •Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
- •Subjects who have participated in other study within 3 months
- •Subjects judged to be unsuitable for this trial by investigator
研究组 & 干预措施
Metformin
Active Comparator
干预措施: Metformin (Drug)
CJ-30001/CJ-30002
Experimental
干预措施: CJ-30001/CJ-30002 (Drug)
结局指标
主要结局
Change from baseline in HbA1c at week 24
时间窗: Baseline, week 24
次要结局
- Percentage of patients achieving HbA1c <6.5% at week 24(week 24)
- Change from baseline in HbA1c, FPG, insulin and GLP-1 at week 4, 8, 12, 18, 24(Baseline, week 4, 8, 12, 18, 24)
- Change from baseline in 2hr PPG and postprandial insulin at week 24(Baseline, week 24)
- Change from baseline in FPG and HbA1c according to HbA1c at baseline(7~8%,8~9%, 9~10%, 10~11%)(Baseline, week 4, 8, 12, 18, 24)
- Percentage of patients achieving HbA1c <7% at week 24(week 24)
- Percentage of patients reaching FPG <126mg/dL at week 24(week 24)
- Percentage of patients reaching 2hr PPG <200mg/dL at week 24(week 24)
- Percentage of patients adjusting to the high dose(week 24)
- Percentage of withdrawing patients due to uncontrolled glucose(week 24)
- Change from baseline in serum lipid(T. cholesterol, HDL, LDL, TG) at week 24(week 24)
- Glycemic variability(Baseline, week 8, 18, 24)
研究者
研究点 (21)
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