NCT02053103终止2 期
A 6-Week Phase 2a Randomized, Double-Blind, Placebo-Controlled Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 In Adult Subjects With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo
研究概览
简要总结
A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks in adult subjects with Type 2 Diabetes Mellitus (T2DM) on metformin background therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months
- •Hemoglobin A1c of 7-10% at screening.
- •Body Mass Index of at least 25 kg/m2.
排除标准
- •Compliant with study drug administration during the run-in period and throughout the trial.
- •Patients with fasting triglycerides greater than 500 mg/dL at screening.
- •History of certain diabetic complications or cardiac problems.
研究组 & 干预措施
PF-05175157
Experimental
干预措施: PF-05175157 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo
时间窗: Baseline, Day 42
次要结局
- Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT)(Weeks 0, 4 and 6)
- Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo(Weeks 0 and 4)
- Change from baseline in low density lipoprotein cholesterol (LDL-C)(Weeks 0, 4 and 6)
- Change from baseline in fasting total cholesterol(Weeks 0, 4 and 6)
- Change from baseline in Glycosylated Hemoglobin (HbA1c)(Weeks 0, 4 and 6)
- Change from baseline in ratio of AUC (0-5) C-peptide to AUC(0-5) glucose during the MMTT(Weeks 0, 4 and 6)
- Change from baseline in ratio of AUC(0-5) insulin to AUC(0-5) glucose during the MMTT(Weeks 0, 4 and 6)
- Percent change from baseline in body weight(Weeks 0, 4 and 6)
- Change from baseline in fasting plasma glucose(Weeks 0, 2, 4 and 6)
- Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT)(Weeks 0, 4 and 6)
- Change from baseline in triglycerides(Weeks 0, 4 and 6)
- Change from baseline in high density lipoprotein cholesterol (HDL-C)(Weeks 0, 4 and 6)
- Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR)(Weeks 0, 4 and 6)
- Plasma concentrations for PF-05175157(Weeks 2, 4 and 6)
- Change from baseline in homeostatic model assessment for β-cell function (HOMA B)(Weeks 0, 4 and 6)
- Change from baseline in non-HDL cholesterol(Weeks 0, 4 and 6)
- Change from baseline in very low density lipoprotein (VLDL)(Weeks 0, 4 and 6)
研究者
研究点 (1)
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