A Double-Blind, Randomized, Placebo- and Active Comparator-Controlled, 4-Week Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of JNJ-41443532 in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 89
- 主要终点
- Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication) and pharmacodynamics (what the medication does to the body) of treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes mellitus participants.
详细描述
This is a randomized (the study medication is assigned by chance), double-blind (neither investigator nor participant knows the treatment that the participant receives), multicenter (study conducted at multiple sites), and placebo (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) and active comparator (an established effective treatment that is compared with a medication to test whether the medication has a real effect in a clinical study) controlled study (placebo or active comparator is compared with the study medication to test whether the study medication has a real effect in clinical study). The study consists of 4 phases: screening phase (45 days before administration of study medication); pre-dosing run-in phase (a phase before a clinical study is commenced when no treatment is given. In this study, participant's glucose level will be observed during run-in-phase: days 15 to 1 before administration of study medication); treatment phase, and follow-up phase (7 to 10 days after the last dose of the study medication). Approximately 88 participants will be enrolled in this study. All participants will be randomly assigned to 4 treatment arms: JNJ-41443532 250 mg; JNJ-41443532 1000 mg; pioglitazone arm; and placebo. Safety evaluations will include assessment of adverse events including ocular assessments, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. The maximum study duration for each participant will be approximately 12 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Type 2 Diabetes Mellitus (T2DM) for at least 3 months prior screening
- •On a stable treatment regimen for at least 2 months prior screening
- •Medically stable on the basis of physical examination, medical history, and clinical laboratory tests performed at screening and 2 days before administration of the study medication
- •Fasting plasma glucose (FPG) concentrations between 140 mg/dL and 270 mg/dL on 2 days before administration of the study medication
- •Agrees to protocol-defined use of effective contraception
排除标准
- •History of other types of diabetes and complications or secondary forms of diabetes
- •History of eating disorder or recent significant changes in body weight (ie, more or equal to 5 percent over 3 months prior to screening) due to dieting or nutritional treatments
- •Taking antihyperglycemic agents (insulin, exenatide, and liraglutide) within 6 months or thiazolidinedione within 3 months of 2 days before administration of the study medication
- •Clinically significant abnormal electrocardiogram
- •History of, or currently active, significant illness or medical disorders, retinal disease, tuberculosis
- •Clinically important serious infection, positive for serology at screening (hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies)
研究组 & 干预措施
JNJ-41443532 250 mg
Participants will receive JNJ-41443532 250 mg in morning and evening for 28 days.
干预措施: JNJ-41443532 (Drug)
JNJ-41443532 250 mg
Participants will receive JNJ-41443532 250 mg in morning and evening for 28 days.
干预措施: Placebo (Drug)
JNJ-41443532 1000 mg
Participants will receive JNJ-41443532 1000 mg (4 X 250 mg) in morning and evening for 28 days.
干预措施: JNJ-41443532 (Drug)
JNJ-41443532 1000 mg
Participants will receive JNJ-41443532 1000 mg (4 X 250 mg) in morning and evening for 28 days.
干预措施: Placebo (Drug)
Pioglitazone
Participants will receive pioglitazone 30 mg in morning for 28 days.
干预措施: Pioglitazone 30 mg (Drug)
Pioglitazone
Participants will receive pioglitazone 30 mg in morning for 28 days.
干预措施: Placebo (Drug)
Placebo
Participants will receive matching placebo for JNJ-41443532 and pioglitazone for 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG)
时间窗: From baseline (Day -1) to Day 28
Difference is calculated as the change in 24-hour WAG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. 24-hour WAG is defined as the area under the plasma glucose concentration time curve over 0 to 24 hours, divided by 24.
次要结局
- Change From Baseline to Day 28 in Fasting Plasma Glucose (FPG)(From baseline to Day 28)
- Change From Baseline to Day 28 in Insulin Secretion(From baseline to Day 28)
- Change From Baseline to Day 28 in Insulin Resistance(From baseline to Day 28)
- Change From Baseline to Day 28 in Systemic Levels of Interleukin 6 (IL-6)(From baseline to Day 28)
- Change From Baseline to Day 28 in Systemic Levels of Interleukin 18 (IL-18)(From baseline to Day 28)
- Change From Baseline to Day 28 in Systemic Levels of C-Reactive Protein (CRP)(From baseline to Day 28)
- Change From Baseline to Day 29 in Body Weight(From baseline to Day 29)