EUCTR2014-002263-15-IT进行中（未招募）1 期
Effects of GLP-1 Receptor Agonist Lixisenatide on Post-prandial Lipid Profile in Obese Type 2 Diabetic Patients
sanofi aventis S.p.A0 个研究点目标入组 36 人开始时间: 2014年6月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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.Male and female patients, 18-70 years of age
- •2.Diagnosis of Type 2 diabetes mellitus (T2DM) treated with Metformin (= 1.5 g/day) and Obesity (BMI > 30 kg/m2) and the following other abnormalities:
- •Abdominal obesity (waist circumference > 102 cm in men and > 88 cm in women), according to NCEP-ATP III (2001)
- •HbA1c = 7 and = 8.5 %. After Sponsor approval, providers might reasonably suggest more stringent HbA1c values (such as 6.5%) for selected individual patients, if this can be managed without significant hypoglycemia or other treatment adverse effects.. Appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant CVD
- •Hypertriglyceridemia (fasting triglyceride levels between 150 mg/dl and 600 mg/dl), cholesterol <300 mg/dl, and/or low high-density lipoprotein (HDL) cholesterol (i.e. serum HDL-cholesterol <40 mg/dl in men and < 50 mg/dl in women)
- •3.Signed written informed consent
- •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 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.At screening: age < legal age of majority
- •2.Type 1 diabetes mellitus
- •4.History of hypoglycaemia unawareness
- •5.Thyroid disease even if under appropriate hormonal replacement therapy or thyroid suppressant (TSH > 5 mU/l with clinical symptoms of hypothyroidism)
- •6.Hepatic disease (AST or ALT > 2 times the upper limit of normal)
- •7.Renal disease (serum creatinine > 1.7 times the upper limit of normal).
- •8.A history of coronary heart disease, cerebrovascular disease or peripheral arterial disease in the 6 months before enrolment and/or concomitant treatment with calcium antagonists, Beta blockers and/or nitrates.
- •9.Women of childbearing potential with no effective contraceptive method, pregnancy or lactation. Women of childbearing potential (pre-menopausal, or women not surgically sterile for at least 3 months prior to the time of screening) must have a confirmed negative pregnancy test at screening visit. They must use an effective contraceptive method throughout the study.
- •10.History of malignancies
- •11.Known history of drug or alcohol abuse within 6 months prior to the time of screening
- •12.Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure >180 mmHg or >95 mmHg, respectively
- •13.Triglycerides > 600 mg/dl
- •14.History of chronic pancreatitis or of idiopathic acute pancreatitis
- •15.History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
- •16.Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening
- •17.Any other clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at the time of screening that in the judgment of the investigator or any sub- investigator would make implementation of the protocol or interpretation of the study results difficult or would preclude the safe participation of the subject in this protocol.
- •18.Use of any glucose-lowering agent(s) other than metformin in the 3 months prior to screening
- •19.Treatment with metformin at a daily dose < 1.5 g/day
- •20.Use of lipid lowering therapy and/or weight lowering drugs within 3 months prior to screening
- •21.Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one consecutive week or more within 3 months prior to the time of screening
- •22.Use of any investigational drug within 3 months prior to screening
- •23.Patients considered by the investigator or any sub investigator as inappropriate for this study for any medical, psychological, social, or geographical reason (e.g. patients that do not take their breakfast in the morning, patients unable to fully understand the nature, scope, and possible consequences of the study; patients unable to fully understand patient’s study documents; impossibility to meet specific protocol requirements, such as scheduled visits; being unable or unwilling to do blood glucose monitoring using the sponsor-provided blood glucose meter at home; likelihood of requiring treatment with drugs not permitted by the clinical study protocol, night shift workers, etc)
- •24.Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- •25.Patient who withdraws consent during the screening.
- •26.Any contra-indication to metformin accordin
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