A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 508
- 主要终点
- Change From Baseline in AIA Titer After 24 Weeks of Treatment
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293 compared with 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
- •T1DM For at least 1 year
- •is currently using or has been using prandial insulin for at least 4 weeks. Participants taking any type of basal insulin should require a total daily dose of >=10 units/day. For participants currently taking pre-mixed insulin, the basal insulin component should be equivalent to a total daily dose of >=10 units/day.
- •is male, or is female who is not of reproductive potential or if of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control during the study and for 14 days after the last dose of study medication
排除标准
- •has had 1 or more severe hypoglycemic episodes associated with hypoglycemic seizure or loss of consciousness within the past 6 months
- •history of ketoacidosis in the last 6 months
- •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].
- •history of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™ or one of its excipients
- •used a formulation of insulin glargine other than Lantus™
- •has received injectable incretin-based therapy within the past 8 weeks
- •on a weight loss program and not in the maintenance phase, or has started a weight loss medication within the past 8 weeks
- •has undergone bariatric surgery within the past 12 months
- •is likely to require treatment for 2 or more consecutive weeks or repeated courses of corticosteroids (note: inhaled, nasal, and topical corticosteroids are permitted)
- •has undergone a surgical procedure within the past 4 weeks or has planned major surgery during the study
- •has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder
- •has severe peripheral vascular disease
- •has high blood pressure
- •has chronic myopathy, or a progressive neurological or neuromuscular disorder
- •has 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
- •has human immunodeficiency virus (HIV)
- •has a hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- •history of malignancy in the past 5 years, 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
- •is currently being treated for hyperthyroidism or has been on a stable dose of thyroid hormone replacement therapy for <6 weeks
- •is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
- •is pregnant or breast-feeding, or is expecting to conceive or donate eggs
- •has donated blood products or has had phlebotomy of >300 mL within the past 8 weeks or intends to donate blood products during the study
- •has poor mental function or works the night shift
研究组 & 干预措施
MK-1293
MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
干预措施: MK-1293 (Drug)
MK-1293
MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
干预措施: Prandial Insulin (Drug)
Lantus
Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
干预措施: Lantus™ (Drug)
Lantus
Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
干预措施: Prandial Insulin (Drug)
结局指标
主要结局
Change From Baseline in AIA Titer After 24 Weeks of Treatment
时间窗: Baseline and Week 24
This immunogenicity analysis will assess the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 24 weeks of treatment. This change from baseline reflects the Week 24 AIA titer minus the Week 0 AIA titer.
Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24
时间窗: Up to Week 24
Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INab) development up through 24 weeks of treatment.
Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24
时间窗: Baseline and Week 24
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 24 A1C minus the Week 0 A1C.
Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24
时间窗: Up to Week 24
Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline.
Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24
时间窗: Up to Week 24
Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline.
次要结局
- Change From Baseline in A1C at Week 52(Baseline and Week 52)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24(Baseline and Week 24)
- Change From Baseline in AIA Titer After 52 Weeks of Treatment(Baseline and Week 52)
- Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24(Week 24)
- Total Insulin Dose at Week 24(Week 24)
- Total Insulin Dose at Week 52(Week 52)
- Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52(Week 52)
- Percentage of Participants With Confirmed Positive AIA Up Through Week 52(Up to Week 52 including baseline)
- Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52(Up to Week 52)
- Change From Baseline in FPG at Week 52(Baseline and Week 52)
- Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52(Up to Week 52)
- Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24(Baseline and Week 24)
- Change From Baseline in 7-point SMBG at Week 52(Baseline and Week 52)
- Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment.(24 weeks)
- Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment.(52 weeks)
- Basal Insulin Dose at Week 52(Week 52)
- Basal Insulin Dose Per kg of Body Weight at Week 52(Week 52)
- Bolus Insulin Dose at Week 52(Week 52)
- Bolus Insulin Dose Per kg of Body Weight at Week 52(Week 52)
- Basal Insulin Dose at Week 24(Week 24)
- Basal Insulin Dose Per kg of Body Weight at Week 24(Week 24)
- Bolus Insulin Dose at Week 24(Week 24)
- Bolus Insulin Dose Per kg of Body Weight at Week 24(Week 24)