EUCTR2008-005128-10-DK进行中（未招募）不适用
Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients with Type 2 Diabetes Treated only with Lifestyle Interventions - GBCK
Eli Lilly and Company - Indianapolis0 个研究点目标入组 225 人开始时间: 2008年11月18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
- 225
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] Have type 2 diabetes based on the disease diagnostic criteria (World Health Organization [WHO] classification)
- •[2] Are antihyperglycemic medication-naïve (diet and exercise only) or are taking metformin as monotherapy and are willing to discontinue this medication.
- •[3] Have completed at least 8 weeks of wash-out prior to randomization, if taking metformin.
- •[4] Have a qualifying HbA1c value (see protocol for criteria)
- •[5] Men or women, aged 18 to 75 years, inclusive.
- •[6] Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must: (a) test negative for pregnancy at Visit 1; (b) agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; and (c) not be breastfeeding.
- •[7] Have a body mass index (BMI) between 23 and 40 kg/m, inclusive, for
- •patients who are native to, and reside in, South and/or East Asia . All other patients
- •must have a BMI between 25 and 40 kg/m, inclusive.
- •[8] Have a stable weight during the 3 months prior to Visit 1.
- •[9] Are well motivated, capable, and willing to:
- •- perform SMBG testing;
- •- learn how to self-inject treatment, as required for this protocol (or be assisted if visually impaired) and;
- •- maintain a study diary, as required for this protocol.
- •[10] Have given written informed consent to participate in this study
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[11] Have type 1 diabetes
- •[12] Are taking any glucose-lowering oral agents other than metformin within 3 months prior to Visit 1.
- •[13] Have been treated with a GLP-1 analog or any other incretin mimetic (e.g. liraglutide or exenatide) within the 6 months prior to Visit 1, or have been treated with insulin therapy for diabetes.
- •[14] Are currently taking prescription or over-the-counter medications to promote weight loss.
- •[15] Are receiving chronic (>2 weeks) systemic glucocorticoid therapy or have received such therapy within 4 weeks prior to Visit 1.
- •[16] Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass surgery, or chronically take drugs that directly reduce gastrointestinal motility.
- •[17] Are currently taking a central nervous system stimulant.
- •[18] Have had any of the following cardiovascular conditions within 6 months prior to Visit 1: acute coronary syndrome, coronary heart disease treated with coronary artery bypass graft surgery or percutaneous coronary intervention (diagnostic
- •angiograms are permitted), heart failure, atrial or ventricular arrhythmia, pacemaker implantation, clinically significant signs of ischemic heart disease, transient ischemic attack, or cerebrovascular accident (stroke).
- •[19] Have poorly controlled hypertension (see protocol), renal artery stenosis, or evidence of labile BP including symptomatic postural hypotension.
- •[20] At Visit 1, an ECG reading considered outside the normal limits (see protocol).
- •[21] Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine transaminase (ALT) levels >3.0 x the upper limit of the reference range at Visit 1.
- •[22] Have obvious clinical signs or symptoms of pancreatitis,a history of chronic pancreatitis or acute pancreatitis at Visit 1. Patients who have amylase =3 times the upper limit of normal and/or lipase =2 times upper limit of normal, as determined by the central laboratory at Visit 1, are excluded.
- •[23] Have a serum creatinine =1.5 mg/dL for men or =1.4 mg/dL for women, or a creatinine clearance <60 mL/minute, at Visit 1.
- •[24] Have uncontrolled diabetes defined as 2 or more episodes of hyperosmolar state requiring hospitalization in the 6 months prior to Visit 1.
- •[25] Have evidence of a significant active, uncontrolled endocrine or autoimmune abnormality.
- •[26] Have a history of a transplanted organ (corneal transplants allowed).
- •[27] Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- •[28] Have any other condition (such as known drug or alcohol abuse or
- •psychiatric disorder), that may preclude the patient from following and completing the protocol.
- •[29] Are investigator site personnel directly affiliated with this study and/or their immediate families.
- •[30] Are Lilly employees.
- •[31] Have received treatment within the last 30 days with a drug that has not received regulatory approval in the respective country for any indication at the time of study entry.
- •[32] Have participated in a study in which a medical or surgical treatment was given within 30 days prior to entry into the study.
- •[33] Have previously completed or withdrawn from this study after providing informed consent.
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