A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Glimepiride In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 304
- 试验地点
- 53
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12
研究概览
简要总结
This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin
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
- 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
- •Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent
排除标准
- •Subjects with recent cardiovascular events, those with evidence of diabetic complications
研究组 & 干预措施
Placebo
Placebo to match PF-04937319 and glimepiride
干预措施: Placebo (Drug)
PF-04937319 10 mg
干预措施: PF-04937319 10 mg (Drug)
PF-04937319 50 mg
干预措施: PF-04937319 50 mg (Drug)
PF-04937319 100 mg
干预措施: PF-04937319 100 mg (Drug)
Glimepiride
干预措施: Glimepiride (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12
时间窗: Baseline (Day 1), Week 12
HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.
次要结局
- Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8(Baseline (Day 1), Week 2, 4, 6, 8)
- Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12(Baseline (Day 1), Week 2, 4, 6, 8, 12)
- Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12(Week 12)
- Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data(Baseline (Day 1) up to Week 14)
- Number of Participants With Increase/Decrease From Baseline Vital Signs Data(Baseline (Day 1) up to Week 14)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days))
- Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode(Baseline (Day 1) up to Week 14)
- Number of Hypoglycemic Events (HAE) Episodes Per Participant(Baseline (Day 1) up to Week 14)
- Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant(Baseline (Day 1) up to Week 14)
- Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14(Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up))
- Number of Participants With Abnormal Laboratory Values(Baseline (Day 1) up to Week 14)