SD in Subjects With T2DM
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Incremental glucose AUC after an oral glucose tolerance test (OGTT)
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of JNJ-38431055 in volunteers with type 2 diabetes mellitus.
详细描述
This is a double-blind (neither physician or participant knows name of the assigned study drug), placebo-controlled (substance containing no medication), crossover study in male and female volunteers with type 2 diabetes mellitus. For each volunteer, the study consists of a screening phase (up to 45 days), a run-in phase during which volunteers discontinue their oral hypoglycemic drugs (28 days), a treatment phase during which volunteers will continue to be off their oral hypoglycemic drugs (28 days) and will receive 4 single dose study treatments in a randomized (study sequence assigned by chance) sequence, and a follow-up phase (10 days). After the follow-up phase volunteers will restart their oral hypoglycemic drugs. During the treatment phase there will be at least 7 days between each of the 4 treatments. The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055, sitagliptin (Januvia), and placebo. The following safety evaluations will be taken throughout the study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the electrical activity of the heart), Blood pressure, heart rate, and blood samples for laboratory tests. The primary outcome will be incremental glucose after an oral glucose tolerance test. Study drug will be administered as single oral doses separated by at least 7 days. The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055, sitagliptin (Januvia), and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or postmenopausal or surgically sterilized females, who have type 2 diabetes mellitus
- •Medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and ECG performed at Screening
- •Body Mass Index (BMI) between 22 and 39.9 kg/m2, inclusive
- •On a generally stable antihyperglycemic agent regimen (i.e., with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to the Screening Visit, including volunteers who are:(a) Not currently on antihyperglycemic therapy and have an HbA1c =7.0% and =10.0%, or (b) On a single oral antihyperglycemic agent [metformin, a sulfonylurea, a meglitinide (e.g., repaglininide or nateglinide), a DPP-4 inhibitor (sitagliptin or vildagliptin), or an alpha-glucosidase inhibitor (e.g., acarbose)] and have an HbA1c >=6.5% and <=9.5%, or (c) On low-dose dual oral agent therapy (i.e., <50% maximum labeled doses of both agents) and have an HbA1c >=6.5% and <=9.5%
- •On Day -1, FPG concentrations between 120 mg/dL and 260 mg/dL, inclusive.
排除标准
- •Taking non-oral antihyperglycemic agent (e.g., insulin, exenatide or other GLP-1 analogues), or taking a thiazolidinedione (i.e., a PPARg agonist) within 3 months of Day -1
- •History of a recent severe hypoglycemic episode, recurrent hypoglycemic episodes (i.e., within the past year), or a history of hypoglycemic unawareness
- •History of clinically significant diabetic complications, including retinopathy, nephropathy, neuropathy or gastroparesis
- •Positive test for alcohol and/or drugs of abuse
- •Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
- •Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements.
研究组 & 干预措施
001
干预措施: JNJ-38431055 Dose 1 (Drug)
002
干预措施: JNJ-38431055 Dose 2 (Drug)
003
干预措施: Placebo (Drug)
004
干预措施: Sitagliptin 100 mg (Drug)
结局指标
主要结局
Incremental glucose AUC after an oral glucose tolerance test (OGTT)
时间窗: 0-4 hours after OGTT
次要结局
- Incremental glucose AUC after a meal tolerance test (MTT)(0-4 hours after MTT)
- Measurements of beta-cell function(0-4 hours after OGTT/MTT)
- Effect on incretin levels(0-4 hours after OGTT)
- Pharmacokinetics(48 hours after dosing)
- Safety and Tolerability(Throughout study)