EUCTR2009-009888-60-IT进行中（未招募）不适用
A 12-week multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design study to evaluate the efficacy on blood glucose control and safety of five doses of LCQ908 (2, 5, 10, 15 and 20 mg) or sitagliptin 100 mg on a background therapy of metformin in obese patients with type 2 diabetes - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 720
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.Written informed consent to participate in the study, before any study related activities are performed, and is likely to comply with all study requirements, including dietary guidelines. 2.Age 18-75 years, inclusive. 3.Males, non-fertile females, and females of non-childbearing potential. Women must be (a) postmenopausal, defined as age >48 with 12 months of natural (i.e. spontaneous) amenorrhea or age >42 with >6 months of spontaneous amenorrhea with serum FSH levels > 30 mIU/mL and estradiol <30 pg/ml ; (b) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (c) have a documented history of tubal ligation at least 1 year prior to screening. 4.Patients with T2DM with HbA1c 7.0 to 10.0%, inclusive, at Visit 1. 5.Fasting plasma glucose ≤250mg/dL (13.9 mmol/L) at Visit 1 assessed by the central laboratory 6.Patients treated with metformin for at least three months prior to Visit 1 (screening) and on a stable dose ≥1500 mg for 4 weeks prior to Visit 3 (randomization). Patients must agree to maintain the same dose of metformin from 4 weeks before Visit 3 to the end of the study. 7.Body mass index (BMI) of 28 to 42 kg/m2 inclusive 8.Body weight at Visit 1 within 5% of their self-reported weight over the past three months and agreement to maintain the study-recommended diet (counseled during screening) and usual exercise habits during the full course of the study. 9.Patients on stable doses of statins or fibrates for 6 weeks prior to Visit 1 must agree to maintain those doses during the study period.
- •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
- •1.A history of type 1 diabetes,diabetes that is a result of pancreatic injury,or secondary forms of diabetes 2.A history of acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state within the past 6 months 3.Evidence of significant diabetic complications,symptomatic autonomic neuropathy,severe diabetic retinopathy,diabetic gastroparesis or enteropathy 4.Treatment with any oral antidiabetic agent other than metformin within 12 weeks prior to Visit 1 5.Chronic insulin treatment within the 6 months prior to Visit 1. 6.Acute infections which may affect blood glucose control 4 weeks prior to Visit 1 and other concurrent medical conditions that may interfere with the interpretation of efficacy and safety during the study.7.Donation of one unit or more of blood,significant blood loss equaling at least one unit of blood within 2 weeks,or a blood transfusion within 8 weeks prior to Visit 1 8.Pregnant or nursing women,where pregnancy is defined as the state of a female after conception and until the termination of gestation,confirmed by a positive hCG laboratory test 9.Severe illness,trauma,or major surgery within 3 months prior to Visit 1 10.Mean sitting diastolic blood pressure>100mmHg and/or mean sitting systolic blood pressure>150mmHg 11.History of Congestive HF or pacemaker use within the past 5 years 12.Any of the following within the past 12 months:a.Myocardial infarction b.Unstable angina c.Arterial revascularization,coronary artery bypass graft surgery,or percutaneous coronary intervention d.Cerebrovascular accident or recurrent transient ischemic attacks 13.Any of the following ECG abnormalities:a.Torsades de pointes,sustained and clinically relevant atrial or ventricular tachycardia,or atrial or ventricular fibrillation b.Second degree AV block c.Third degree AV block d.Prolonged QTc at screening confirmed by visual inspection of the electrocardiogram 14.Liver disease such as cirrhosis or chronic active hepatitis B and C 15.Impaired renal function including a history of dialysis or of nephrotic syndrome and/or estimated creatinine clearance less than 50 ml/min 16.Any of the following significant laboratory abnormalities at Visit 1: a.ALT and/or AST>2 times the upper limit of normal,confirmed by a repeat measurement within 3 working days b.Total bilirubin>2times ULN and/or direct bilirubin greater than the ULN, confirmed by a repeat measurement within 3 working days c.Thyroid stimulating hormone<0.3 and >5.5 µU/ml d.Platelet count<100,000/ml,white blood cell count<4000/ml e.Hemoglobin<12g/L in men,<11g/L in women f.Fasting Triglycerides>500mg/L g.Fasting LDL cholesterol>130mg/L unless on a statin h.Positive HIV test,currently treated for HIV,presence of Hepatitis C antibodies or positive Hepatitis B serology indicative of ongoing or latent disease 17.Any of the following concomitant medications:Any anti-diabetic medication other than metformin,Any new lipid lowering therapy,Bile resin binders such as cholestyramine,ezetimibe,or colesevelam
- •Class Ia,Ib,Ic or III antiarrhythmics
- •Warfarin and dicoumadin derivatives
- •Chronic oral or parenteral,corticosteroid treatment within the past 8 weeks,Growth hormone,synthetic androgens,or similar drugs,Selective Serotonin Reuptake Inhibitors unless the patient has been on a stable dose for at least 3 months prior to Visit 1 and remains on the same dose for the duration of the
- •study,Tricyclic antidepressants
- •Other investigational drugs at the time of enrollment,o
研究者
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