EUCTR2009-015993-37-DE进行中（未招募）不适用
Beta Cell Relieving and Cardiovascular Protective Effects of LANTUS Treatment in Type 2 Diabetes Patients – Investigation on Postprandial Excursions of Proinsulin and PAI-1 Levels
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.Inclusion criteria – applicable for T2DM group only:
- •1.1.Type 2 diabetes mellitus
- •1.2.Duration of T2DM between 3 and 15 years inclusively
- •1.3.HbA1c up to 7.5% inclusively
- •1.4.1.4.Treated with LANTUS+MET (Group LANTUS+MET) or SU+MET (Group SU+MET) or DPP-4+MET (Group DPP-4+MET) respectively during the past 6 months before entering the study
- •1.5.Treated on a stable antidiabetic dosage during the past 3 months before entering the study
- •2.Inclusion criteria – applicable for healthy subject only:
- •2.1.Fasting blood glucose £ 100 mg/dl (5.6 mmol/l)
- •2.2.Oral Glucose Tolerance Test (OGTT) revealed no IGT or DM
- •3.Age of 40-75 years inclusively
- •4.BMI between 20 and 35 kg/m2 inclusively
- •5.Patient 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Exclusion criteria – applicable for T2DM group only:
- •1.1.Type 1 diabetes mellitus
- •1.2.1.2.Treatment with any other insulin than LANTUS during the past
- •6 months in Group LANTUS+MET or with any kind of insulin during the past 3 months in Group SU+MET or Group DPP-4+MET before entering the study
- •1.3.Treatment with any kind of OAD except MET during the past 6 months in Group LANTUS+MET or with any kind of OAD except MET+SU during the past 3 months in Group SU+MET or with any kind of OAD except DPP-4+SU during the past 3 months in Group DPP-4+MET before entering the study
- •1.4.Major micro- or macro vascular complications as judged by the investigator
- •2.Exclusion criteria – applicable for healthy subject only:
- •2.1.Type 1 or type 2 diabetes mellitus (checked by oGTT)
- •2.2.Impaired Glucose Tolerance (IGT, checked by oGTT)
- •2.3.Impaired Fasting Glucose (IFG, checked by oGTT)
- •3.History of drug or alcohol abuse within the last five years prior to screening
- •4.History of severe or multiple allergies
- •5.Treatment with any other investigational drug within 3 months prior to screening
- •6.Progressive fatal disease
- •7.Known psychiatric illness
- •8.History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.1 mg/dl in women and > 1.5 mg/dl in men), neurological, psychiatric and/or haematological disease as judged by the investigator
- •9.Pregnancy or breast feeding
- •10.Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner
- •11.Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
研究者
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