NCT01169090已完成2 期
A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Phase 2 Dose Finding Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 620
- 主要终点
- Change in HbA1c from baseline to Week 16.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a range of doses of SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone.
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
- Double (Participant, Investigator)
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
- •Male and female subjects with type 2 diabetes between 18 and 75 years of age, inclusive
- •Screening HbA1c between 7.0% to 10.0% for metformin stable subjects, 6.5% to 9.0% for subjects on metformin and 1 other antidiabetic agent (excluding thiazolidinediones, insulin, or incretin therapies [DPP-4 inhibitors and GLP-1 analogues]), or 7.5% to 11.0% for subjects on no antidiabetic medication or, if taking metformin, not on a stable dose of 1500 mg/day or maximum tolerated dose.
- •No antidiabetic medication other than metformin for 3 months prior to randomization.
- •Fasting plasma glucose less than 270 mg/dL (15 mmol/L) at screening.
- •Body mass index between 20 kg/m2 and 45 kg/m2 inclusive at screening.
排除标准
- •History of type 1 diabetes.
- •Received treatment with insulin within 30 days of the screening visit or for more than 1 week within 3 months of the screening visit.
- •Use of 3 or more oral antidiabetic medications at the time of the screening visit.
研究组 & 干预措施
SK-0403 100 mg QD
Experimental
干预措施: SK-0403 (Drug)
SK-0403 200 mg QD
Experimental
干预措施: SK-0403 (Drug)
SK-0403 400 mg QD
Experimental
干预措施: SK-0403 (Drug)
SK-0403 200 mg BID
Experimental
干预措施: SK-0403 (Drug)
Placebo
Sham Comparator
干预措施: Placebo (Drug)
Sitagliptin 100 mg QD
Active Comparator
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Change in HbA1c from baseline to Week 16.
时间窗: Baseline, 16 weeks
Change in HbA1c from baseline to Week 16 with last observation carried forward (LOCF).
次要结局
- Change from baseline in Fasting Plasma Glucose (FPG)(Baseline, 16 weeks)
研究者
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