NCT00674466已完成2 期
A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Phase II Study to Evaluate the Efficacy and Safety of 3 Months of Twice-a-week Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
ConjuChem1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction of HbA1c From Baseline
研究概览
简要总结
This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients who are currently on metformin monotherapy.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI: 27 to 45 kg/m2
- •Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator
- •Stable life-style, i.e. diet & physical activity, as determined by the Investigator
- •Stable metformin daily dose ≥1000 mg for at least 3 months
- •Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Twice-a-week dose of 1.5 mg CJC-1134-PC
干预措施: 1.5 mg or 2.0 mg CJC-1134-PC (Drug)
2
Experimental
Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo
干预措施: 1.5 mg or 2.0 mg CJC-1134-PC (Drug)
3
Placebo Comparator
Twice-a-week placebo for CJC-1134-PC
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction of HbA1c From Baseline
时间窗: Screening and Day 85
Change from baseline
次要结局
- Reduction in Fasting Body Weight From Baseline(Screening and Day 85)
- Reduction in Fasting Plasma Glucose From Baseline(Screening and Day 85)
研究者
研究点 (1)
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