NCT01464437已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Explore Dose Effect and Frequency of Administration of AMG 151 in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin
研究概览
简要总结
This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years, inclusive
- •Diagnosis of type 2 diabetes mellitus
- •HbA1c levels 7.5% to 11.0%, inclusive, at screening
- •Fasting C-peptide levels ≥ 0.2 nmol/L at screening
- •BMI ≥ 25 to < 45 kg/m2 at screening
- •Treated with metformin monotherapy for at least 3 months prior to randomization; the metformin dose must be ≥ 850 mg daily for at least 2 months immediately prior to randomization
- •If a subject is being treated for hyperlipidemia or hypertension they should be on stable medication for 30 days before randomization
- •Subject has provided informed consent.
排除标准
- •History of type 1 diabetes
- •History of significant weight gain or loss (> 10%) during the 4 weeks before randomization
- •Use of any weight loss medication (over the counter or prescription) within 60 days of randomization
- •Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization
- •Use of chronic and/or continuous insulin administration for > 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization
- •Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
- •Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness
- •Evidence of active infections that can interfere with the study
- •Presence of clinically significant organ system disease that is not stabilized or may interfere with the study
- •Currently receiving immunosuppressive therapy
- •History of positive HIV, chronic hepatitis B or C, or cirrhosis
- •Have symptomatic congestive heart failure or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure or stroke in the past 6 months prior to screening.
- •History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
- •Any finding on the screening ECG that in the opinion of the investigator requires further cardiovascular evaluation
- •Poorly controlled hypertension defined as diastolic pressure > 100 mm Hg or systolic pressure > 160 mm Hg (assessed on two separate occasions during the screening period)
- •Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease-free state since treatment)
- •Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to randomization
研究组 & 干预措施
AMG 151 - Arm 1
Active Comparator
AMG 151 - Arm 1
干预措施: AMG 151 (Drug)
AMG 151 - Arm 1
Active Comparator
AMG 151 - Arm 1
干预措施: Metformin (Drug)
AMG 151 - Arm 2
Active Comparator
AMG 151 - Arm 2
干预措施: Metformin (Drug)
AMG 151 - Arm 2
Active Comparator
AMG 151 - Arm 2
干预措施: AMG 151 (Drug)
AMG 151 - Arm 3
Active Comparator
AMG 151 - Arm 3
干预措施: Metformin (Drug)
Placebo Arm
Placebo Comparator
AMG 151 Placebo Arm
干预措施: Placebo (Drug)
AMG 151 - Arm 3
Active Comparator
AMG 151 - Arm 3
干预措施: AMG 151 (Drug)
AMG 151 - Arm 4
Active Comparator
AMG 151 - Arm 4
干预措施: Metformin (Drug)
AMG 151 - Arm 4
Active Comparator
AMG 151 - Arm 4
干预措施: AMG 151 (Drug)
AMG 151 - Arm 5
Active Comparator
AMG 151 - Arm 5
干预措施: Metformin (Drug)
AMG 151 - Arm 5
Active Comparator
AMG 151 - Arm 5
干预措施: AMG 151 (Drug)
AMG 151 - Arm 6
Active Comparator
AMG 151 - Arm 6
干预措施: Metformin (Drug)
AMG 151 - Arm 6
Active Comparator
AMG 151 - Arm 6
干预措施: AMG 151 (Drug)
Placebo Arm
Placebo Comparator
AMG 151 Placebo Arm
干预措施: Metformin (Drug)
结局指标
主要结局
To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin
时间窗: Change in fasting plasma glucose levels from baseline to Day 28
次要结局
- To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test(Change in area under the curve from 0-4 hours (AUC0-4hr) glucose after a meal tolerancetest from baseline to Day 28, Change in incremental AUC0-4hr glucose after a meal tolerance test from baseline to Day 28)
- Adverse events(Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.)
研究者
研究点 (1)
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