A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 414
- 主要终点
- Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study
研究概览
简要总结
The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1) Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.
详细描述
The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). Participants will receive in Phase A: omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo and in Phase B: omarigliptin 25 mg once weekly.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has type 2 diabetes mellitus
排除标准
- •History of type 1 diabetes mellitus or a history of ketoacidosis
- •History of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime
研究组 & 干预措施
Omarigliptin 25 mg (Phase A+B)
Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
干预措施: Placebo to sitagliptin (Drug)
Omarigliptin 25 mg (Phase A+B)
Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
干预措施: Omarigliptin (Drug)
Sitagliptin (Phase A) switching to Omarigliptin (Phase B)
Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
干预措施: Omarigliptin (Drug)
Sitagliptin (Phase A) switching to Omarigliptin (Phase B)
Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
干预措施: Sitagliptin (Drug)
Sitagliptin (Phase A) switching to Omarigliptin (Phase B)
Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
干预措施: Placebo to omarigliptin (Drug)
Placebo (Phase A) switching to Omarigliptin (Phase B)
Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
干预措施: Omarigliptin (Drug)
Placebo (Phase A) switching to Omarigliptin (Phase B)
Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
干预措施: Placebo to omarigliptin (Drug)
Placebo (Phase A) switching to Omarigliptin (Phase B)
Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
干预措施: Placebo to sitagliptin (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study
时间窗: Up to 52 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24
时间窗: Baseline and Week 24
HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).
Percentage of Participants Who Experienced at Least One Adverse Event During Phase A
时间窗: Up to 24 weeks
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
时间窗: Up to 24 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
时间窗: Up to 52 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
次要结局
- Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24(Baseline and Week 24)
- Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24(Baseline and Week 24)