NCT02059187已完成3 期
A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 531
- 主要终点
- Change From Baseline in Participant Hemoglobin A1C Level at Week 24
研究概览
简要总结
This 24-week study is a safety and efficacy comparison of MK-1293 and Lantus™ in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior (with margin of 0.4%) in participants treated with MK-1293 compared with that in participants treated with Lantus™.
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
- None
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
- •Diagnosis of Type 2 Diabetes Mellitus (T2DM) as defined by the American Diabetes Association (ADA) or the European Association for the Study of Diabetes (EASD)
- •hemoglobin A1C of ≤11.0% and requires insulin for glycemic control
- •Body mass index (BMI) <45 kg/m^2
排除标准
- •History of type 1 diabetes mellitus or a history of ketoacidosis, or has type 1 diabetes confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L)
- •One or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within the past 6 months
- •History of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™ or one of its excipients based on the label of the country of the investigational site
- •On a weight loss program within the last 8 weeks
- •Received injectable incretin-based therapy (e.g., Victoza™, Byetta™) within the prior 8 weeks
- •Bariatric surgery within 12 months prior to signing the informed consent
- •Likely to require treatment for ≥2 consecutive weeks or repeated courses of corticosteroids
- •Undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the study
- •New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the last 3 months
- •Presence of any of the following during the last 3 months: acute coronary syndrome, coronary artery intervention, and/or stroke or transient ischemic neurological disorder
- •Severe peripheral vascular disease
- •Systolic blood pressure ≥ 160 mm Hg or a diastolic ≥95 mm Hg and blood pressure is not considered likely to be under these limits with an adjustment in antihypertensive medication
- •Chronic myopathy or a progressive neurological or neuromuscular disorder
- •Active nephropathy
- •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)
- •Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- •History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- •History of melanoma, leukemia, lymphoma, or renal cell carcinoma
- •Hyperthyroidism
- •On a stable dose of thyroid hormone replacement therapy for <6 weeks
- •Uses recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
- •Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug
- •Donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intends to donate blood products within the projected duration of the study
- •Poor mental function or any other reason to expect that the participant may have difficulty in complying with the requirements of the study
- •Clinically significant ECG abnormality which exposes the participant to risk by enrolling in the study
- •Positive urine pregnancy test
- •Participant is a night shift worker which causes difficulty complying with the overnight fast requirement and has potential for confounding the 7-point SMBG analysis
- •Participant, as assessed by the investigator, is not appropriate for or does not agree to target a fasting glucose of 70-100 mg/dL [3.9 -5.6 mmol/L]
- •Has used a formulation of glargine insulin other than Lantus™
研究组 & 干预措施
MK-1293
Experimental
MK-1293 administered subcutaneously once daily in the evening.
干预措施: MK-1293 (Drug)
MK-1293
Experimental
MK-1293 administered subcutaneously once daily in the evening.
干预措施: Prandial insulin (Drug)
Lantus™
Active Comparator
Lantus™ administered subcutaneously once daily in the evening.
干预措施: Lantus™ (Drug)
Lantus™
Active Comparator
Lantus™ administered subcutaneously once daily in the evening.
干预措施: Prandial insulin (Drug)
结局指标
主要结局
Change From Baseline in Participant Hemoglobin A1C Level at Week 24
时间窗: Baseline and Week 24
A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications.
Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24
时间窗: Up to 24 weeks
Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24.
次要结局
- Daily Basal Insulin Dose (Units) at Week 24(Week 24)
- Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24(Week 24)
- Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24(Baseline and Week 24)
- Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24(Baseline and Week 24)
- Change From Baseline in Participant Body Weight at Week 24(Baseline and Week 24)
- Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24(Up to 24 weeks)
- Percentage of Participants Experiencing an AE Over the 24-week Treatment Period(Up to 24 weeks)
- Percentage of Participants With Hemoglobin A1C <7% at Week 24(Week 24)
- Percentage of Participants With Hemoglobin A1C <6.5% at Week 24(Week 24)
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