A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Safety, Tolerability And Efficacy Of Once Daily PF-04971729 And Hydrochlorothiazide In Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic And Blood Pressure Control
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 194
- 主要终点
- Baseline 24-hour Average Systolic Blood Pressure (SBP)
研究概览
简要总结
MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either placebo, 1 of 3 doses of ertugliflozin [1, 5, or 25 mg], or the approved drug hydrochlorothiazide [HCTZ]). The primary hypothesis of the study was that ertugliflozin was superior to placebo on the change from baseline in average, 24-hour systolic blood pressure (SBP) on Day 28.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with type 2 diabetes and hypertension
- •Medically stable
- •On at least 1 (and up to 2) oral diabetes drugs
- •And up to 2 medicines for blood pressure control
排除标准
- •Participants with type 1 diabetes
- •Heart attack
- •Uncontrolled blood pressure
- •Significant kidney disease
研究组 & 干预措施
Ertugliflozin 5 mg
Ertugliflozin 5 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
干预措施: Ertugliflozin 5 mg (Drug)
Placebo
Placebo to ertugliflozin (resembling either 1 mg or 5 mg), placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days.
干预措施: Placebo to Ertuglilflozin 1 or 5 mg (Drug)
Placebo
Placebo to ertugliflozin (resembling either 1 mg or 5 mg), placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days.
干预措施: Placebo to HCTZ (Drug)
Placebo
Placebo to ertugliflozin (resembling either 1 mg or 5 mg), placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days.
干预措施: Placebo to ertuglilflozin 25 mg (Drug)
Ertugliflozin 1 mg
Ertugliflozin 1 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
干预措施: Ertugliflozin 1 mg (Drug)
Ertugliflozin 1 mg
Ertugliflozin 1 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
干预措施: Placebo to HCTZ (Drug)
Ertugliflozin 1 mg
Ertugliflozin 1 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
干预措施: Placebo to ertuglilflozin 25 mg (Drug)
Ertugliflozin 5 mg
Ertugliflozin 5 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
干预措施: Placebo to HCTZ (Drug)
Ertugliflozin 5 mg
Ertugliflozin 5 mg, placebo to ertugliflozin (resembling 25 mg), and placebo to HCTZ once daily for 28 days
干预措施: Placebo to ertuglilflozin 25 mg (Drug)
Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to HCTZ once daily for 28 days
干预措施: Placebo to Ertuglilflozin 1 or 5 mg (Drug)
Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to HCTZ once daily for 28 days
干预措施: Ertugliflozin 25 mg (Drug)
Ertugliflozin 25 mg
Ertugliflozin 25 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to HCTZ once daily for 28 days
干预措施: Placebo to HCTZ (Drug)
HCTZ 12.5mg
HCTZ 12.5 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to ertugliflozin (resembling 25 mg) once daily for 28 days
干预措施: Placebo to Ertuglilflozin 1 or 5 mg (Drug)
HCTZ 12.5mg
HCTZ 12.5 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to ertugliflozin (resembling 25 mg) once daily for 28 days
干预措施: HCTZ 12.5mg (Drug)
HCTZ 12.5mg
HCTZ 12.5 mg, placebo to ertugliflozin (resembling either 1 mg or 5 mg), and placebo to ertugliflozin (resembling 25 mg) once daily for 28 days
干预措施: Placebo to ertuglilflozin 25 mg (Drug)
结局指标
主要结局
Baseline 24-hour Average Systolic Blood Pressure (SBP)
时间窗: 24 hours
Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM).
Change From Baseline on 24-hour Average SBP at Week 4
时间窗: Baseline and Week 4
Change from baseline on 24-hour average SBP at Week 4 assessed using 24-hour ABPM. In the case of missing data, last observation carried forward (LOCF).
次要结局
- Baseline Average Daytime and Nighttime SBP(Daytime: 16 hours; Nighttime: 8 hours)
- Change From Baseline on Daytime Average SBP at Week 4(Baseline and Week 4)
- Change From Baseline on Nighttime Average SBP at Week 4(Baseline and Week 4)
- Baseline Seated, Triplicate Trough SBP(Baseline)
- Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP)(up to 24 hours)
- Change From Baseline in Seated, Triplicate Trough SBP at Week 4(Baseline and Week 4)
- Change From Baseline on Daytime Average DBP at Week 4(Baseline and Week 4)
- Change From Baseline on Nighttime Average DBP at Week 4(Baseline and Week 4)
- Baseline Seated, Triplicate Trough DBP(Baseline)
- Change From Baseline in Seated, Triplicate Trough DBP at Week 4(Baseline and Week 4)
- Change From Baseline on 24-hour Average DBP at Week 4(Baseline and Week 4)
- Baseline 24-hour, Daytime and Nightime Average Heart Rate(up to 24 hours)
- Change From Baseline on 24-hour Average Heart Rate at Week 4(Baseline and Week 4)
- Change From Baseline on Daytime Average Heart Rate at Week 4(Baseline and Week 4)
- Change From Baseline on Nighttime Average Heart Rate at Week 4(Baseline and Week 4)
- Baseline Seated, Triplicate Trough Heart Rate(Baseline)
- Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4(Baseline and Week 4)
- Baseline 24-hour Average Urinary Glucose Excretion(24 hours)
- Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4(Baseline and Week 4)
- Baseline Fasting Plasma Glucose (FPG)(Baseline)
- Change From Baseline in FPG at Week 4(Baseline and Week 4)
- Change From Baseline in FPG at Week 2(Baseline and Week 2)
- Number of Participants Who Experienced an Adverse Event (AE)(Up to 63 days (including run-in, treatment period, and follow-up))
- Number of Participants Who Discontinued Study Drug Due to an AE(Up to 28 days (treatment period))