A Phase III, Multicenter, Double-Blind, Randomized Trial to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus For Whom Metformin is Inappropriate Due to Intolerance or Contraindication
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 65
- 主要终点
- Change From Baseline in Hemoglobin A1C (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 who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis 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
- •Have intolerability to metformin ≥1000 mg/day or have a contraindication to the use of metformin
- •Females of reproductive potential agree to remain abstinent or use or have their partner use 2 acceptable methods of birth control
排除标准
- •History of type 1 diabetes mellitus or a history of ketoacidosis or assessed by the investigator as possibly having type 1 diabetes
- •Has been treated with:
- •A thiazolidinedione (TZD) within 4 months of study participation, or
- •A glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist (such as exenatide or liraglutide) within 6 months of study participation, or
- •Insulin within 12 weeks prior to study participation, or
- •Dual antihyperglycemic agent (AHA) therapy within 12 weeks of study participation (4 months if a component of the dual AHA therapy was a TZD)
- •Omarigliptin (MK-3102) at any time prior to study participation
- •On a weight loss program and is not in the maintenance phase; 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 (HIV)
- •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
Omarigliptin
Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
干预措施: Omarigliptin (Drug)
Omarigliptin
Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
干预措施: Glimepiride Placebo (Drug)
Glimepiride
Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
干预措施: Glimepiride (Drug)
Glimepiride
Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
干预措施: Omarigliptin Placebo (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1C (A1C) at Week 54
时间窗: Baseline and Week 54
A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.
Percentage of Participants Who Experienced at Least One Adverse Event
时间窗: Up to 57 weeks (including 3 weeks following the last dose of study drug)
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
时间窗: Up to 54 weeks
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54(Baseline and Week 54)
- Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment(54 weeks)
- Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment(54 weeks)
- Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia(Up to 54 weeks)
- Change From Baseline in Body Weight at Week 54(Baseline and Week 54)