A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 751
- 主要终点
- Change From Baseline in Hemoglobin A1C at Week 54
研究概览
简要总结
This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Type 2 diabetes mellitus
- •On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control
- •Females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control
排除标准
- •History of type 1 diabetes mellitus or a history of ketoacidosis
- •Treated with any antihyperglycemic agents (AHA) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with omarigliptin at any time prior to signing informed consent
- •On a weight loss program and is not in the maintenance phase or has
- •started a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation
- •Medical history of active liver disease (other than non-alcoholic
- •hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
- •Human immunodeficiency virus
- •New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke or transient ischemic neurological disorder within the past 3 months
- •History of malignancy ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer, or in situ
- •cervical cancer
- •Clinically important hematological disorder (such as aplastic anemia,
- •myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- •Pregnant or breast-feeding, or is expecting to conceive or donate eggs
- •during the trial, including 21 days following the last dose of study drug
研究组 & 干预措施
Glimepiride
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
干预措施: Placebo to Omarigliptin (Drug)
Omarigliptin
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
干预措施: Omarigliptin (Drug)
Omarigliptin
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
干预措施: Glimepiride Placebo (Drug)
Omarigliptin
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
干预措施: Metformin (Drug)
Omarigliptin
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
干预措施: Insulin Glargine (Drug)
Glimepiride
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
干预措施: Glimepiride (Drug)
Glimepiride
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
干预措施: Metformin (Drug)
Glimepiride
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1C at Week 54
时间窗: Baseline and Week 54
Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue
时间窗: Up to Week 57
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.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue
时间窗: Up to Week 54
次要结局
- Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54(Week 54)
- Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue(Up to Week 54)
- Change From Baseline in Fasting Plasma Glucose at Week 54(Baseline and Week 54)
- Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue(Baseline and Week 54)
- Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54(Week 54)