A Phase III, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of Addition of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Oral Antihyperglycemic Agent Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 585
- 主要终点
- Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A
研究概览
简要总结
This study will examine the safety and efficacy of the addition of omarigliptin in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.
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). During Phase A, participants will received either omarigliptin 25 mg or a matching placebo. During Phase, B all participants will receive omarigliptin 25 mg. All participants will remain on a stable dose and administration of a single oral antihyperglycemic basal medication.
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
- •Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy
排除标准
- •History of type 1 diabetes mellitus or a history of ketoacidosis
- •History of any of the following medications: Thiazolidinediones (TZD) (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, omarigliptin anytime
研究组 & 干预措施
Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SUs throughout the duration of the study.
干预措施: Omarigliptin (Drug)
Omarigliptin 25 mg/Glinides (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of glinides throughout the duration of the study.
干预措施: Omarigliptin (Drug)
Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BGs throughout the duration of the study.
干预措施: Omarigliptin (Drug)
Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZDs throughout the duration of the study.
干预措施: Omarigliptin (Drug)
Omarigliptin 25 mg/α-GIs (Phase A+B)
Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GIs) inhibitors throughout the duration of the study.
干预措施: Omarigliptin (Drug)
Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SUs throughout the duration of the study.
干预措施: Omarigliptin (Drug)
Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SUs throughout the duration of the study.
干预措施: Matching placebo to omarigliptin (Drug)
Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of glinides throughout the duration of the study.
干预措施: Omarigliptin (Drug)
Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B)
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of glinides throughout the duration of the study.
干预措施: Matching placebo to omarigliptin (Drug)
Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BGs throughout the duration of the study.
干预措施: Omarigliptin (Drug)
Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B)
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BGs throughout the duration of the study.
干预措施: Matching placebo to omarigliptin (Drug)
Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZDs throughout the duration of the study.
干预措施: Omarigliptin (Drug)
Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B)
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZDs throughout the duration of the study.
干预措施: Matching placebo to omarigliptin (Drug)
Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GIs inhibitors throughout the duration of the study.
干预措施: Omarigliptin (Drug)
Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B)
Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GIs inhibitors throughout the duration of the study.
干预措施: Matching placebo to omarigliptin (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
次要结局
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24(Baseline and Week 24)