EUCTR2007-000031-26-DE进行中（未招募）不适用
A 12-Week, Double-Blind, Randomized, Placebo-Controlled Study in Type 2 Diabetes Mellitus Subjects to Evaluate the Efficacy, Safety and Tolerability of MTP Inhibitor JNJ-16269110 - N/A
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium0 个研究点目标入组 320 人开始时间: 2007年8月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men or women with a history of T2DM and treated with a stable dose of metformin for at least 2 months prior to screening.
- •2. Between 18 and 70 years of age, inclusive
- •3. Women must be postmenopausal, defined as having a last menstrual period at least 1 year before screening with a serum follicle stimulating hormone (FSH) level consistent with postmenopausal status;
- •or surgically incapable of childbearing (have had a hysterectomy or bilateral oophorectomy or tubal ligation or otherwise incapable of pregnancy);
- •or if sexually active, be practicing an effective method of birth control (e.g. spermicide plus barrier, oral contraceptive plus barrier, intrauterine device, or a partner with a vasectomy);
- •sexually abstinent.
- •4. BMI between 25 and 45 kg/m2, inclusive, measured at screening visit.
- •5. HbA1c between 7% and 10%, inclusive, measured at screening visit.
- •6. Fasting plasma glucose not exceeding 240 mg/dL (13.3mmol/L) at baseline visit.
- •7. Consumption of breakfast and dinner on a daily basis.
- •8. Ability to swallow the intact capsule (17.5 mm in length and 9.1 mm in diameter) with water.
- •9. Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucometer at home.
- •10. Willing to adhere to the prohibitions and restrictions specified in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Diabetes other than type 2 diabetes mellitus.
- •2.Treatment with oral anti-diabetic agents (other than metformin) or insulin during the 12 weeks before baseline visit.
- •3.Prior exposure or known contraindication or hypersensitivity to JNJ 16269110.
- •4.History of intolerance to or hypersensitivity to sulfonylurea or sitagliptin.
- •5.History of an uninterrupted period of insulin therapy for >1 month period within 1 year prior to baseline visit.
- •6.Likelihood of requiring treatment during the study period with anti-diabetic medications such as sulphonylureas, meglitinides, thiazolidinediones, acarbose, dipeptidyl peptidase inhibitors, exenatide and insulins.
- •7.Treatment with any investigational drug or devices in the 1 month before baseline visit.
- •8.Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to baseline visit, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation) during the study.
- •9.History of diabetic gastroparesis that is considered to be clinically significant in the opinion of the investigator.
- •10.Concurrent use of systemic corticosteroids or intend to be placed on a course of systemic corticosteroids for >1 week during the study.
- •11.History or evidence of liver disease, including cirrhosis, or non-alcoholic steatohepatitis/non-alcoholic fatty liver disease.
- •12.History of HIV or presence of hepatitis C antibodies or positive hepatitis B serology (refer to Attachment 10, Interpretation of Hepatitis B Results for Enrolling Subjects) at screening.
- •13.History of clinically significant gastro-intestinal disease (including but not limited to gluten and non-gluten induced enteropathy, inflammatory bowel disease, malabsorption syndromes).
- •14.History of hemoglobinopathy (unreliable HbA1c measurement)
- •15.History of major gastro-intestinal surgery other than appendectomy or uncomplicated cholecystectomy.
- •16.Pregnancy or nursing or women who plan to become pregnant during the study
- •17.History of significant cardiovascular disease, including a history of myocardial infarction (MI), unstable angina and cerebrovascular accident (CVA) within 6 months of enrollment.
- •18.History of clinically-significant cardiac valvular disease, significantly, congestive heart failure (cardiovascular disability functional Class III-IV according to the New York Heart Association, see Attachment 6).
- •19.12-lead ECG showing evidence of clinically significant heart rhythm or conduction abnormality at screening or baseline.
- •20.An average of 3 seated readings where diastolic blood pressure ³100 mmHg or a systolic blood pressure ³160 mmHg at screening.
- •21.Thyroid stimulating hormone (TSH) >1.5 X ULN at enrollment. Subjects on medication for hypothyroidism should have been on a stable dose for at least 3 months before the screening visit.
- •22.History of anorexia nervosa, bulimia or binge eating disorder.
- •23.Recently (within 3 months from screening) changed smoking habits.
- •24.Malignancy or a history of a malignancy within 5 years before Baseline visit, other than basal cell carcinomas of the skin or in situ cervical carcinoma.
- •25.History or evidence of clinically significant abnormal values for hematology, coagulation or clinical biochemistry.
- •26.Increased liver function tests, if concomitant increase of two or more parameters, including AST, ALT bilirubin, alkaline phosphatase
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