NCT01933672已完成1 期
A Phase 1b, Randomized, Double-blind, Active Comparator Controlled, 3-period, Cross-over Study To Characterize The Pharmacodynamics And Tolerability Of Two Dosing Regimens Of Pf-04937319 In Adults 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
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 33
- 试验地点
- 8
- 主要终点
- Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14
研究概览
简要总结
Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos)
排除标准
- •Patients with cardiovascular event within 6-months of screening
- •Patients with diabetic complications
- •Female subjects who are pregnant or planning to become pregnant
- •Subjects with unstable medical conditions (eg, hypertension)
研究组 & 干预措施
PF-04937319 once-daily
Experimental
干预措施: PF-04937319 once-daily (Drug)
PF-04937319 split-dose
Experimental
干预措施: PF-04937319 split-dose (Drug)
Sitagliptin once-daily
Active Comparator
干预措施: Sitagliptin once-daily (Drug)
结局指标
主要结局
Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14
时间窗: Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14
Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14(Day 14)
- Change From Baseline in Pre-meal C-Peptide on Day 14(Day 14)
- Change From Baseline in Pre-meal Insulin on Day 14(Day 14)
- Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%)(Day 1 up to Day 14)
- Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group(Day 1 up to Day 14)
- Change From Baseline in Body Weight (kg)(Day 1 up to Day 14)
- Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern(Day 1 up to Day 14)
- Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern(Day 1 up to Day 14)
- Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14(Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.)
- Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14(Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.)
- Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14(Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.)
- Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14(Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.)
- Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14(Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.)
- Plasma PF-04937319 Time for Cmax (Tmax) on Day 14(Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.)
研究者
研究点 (8)
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