EUCTR2012-000179-17-DE进行中（未招募）不适用
Effect of Linagliptin in comparison with Glimepiride as add on to Metformin on postprandial beta cell function, postprandial metabolism and oxidative stress in patients with type 2 diabetes mellitus
ikfe GmbH0 个研究点开始时间: 2012年2月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Diabetes mellitus type 2
- •2.HbA1c = 6.5% - = 8.5%
- •3.HbA1c = 7.0% - = 8.5% for those patients with a significant cardiovascular history
- •4.Treatment with metformin at a maximum tolerated dose
- •5.Age 45 – 75 years (inclusively)
- •6.Patient consents that his/her family physician/diabetologist will be informed of trial participation.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •11.Pretreatment with PPAR gamma agonists within the last three months
- •2.History of type 1 diabetes
- •3.Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg)
- •4.Acute infections
- •5.Medical history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- •6.History of severe or multiple allergies
- •7.Treatment with any other investigational drug within 3 months before trial entry.
- •8.Progressive fatal disease
- •9.History of drug or alcohol abuse in the past 2 years
- •10.State after kidney transplantation
- •11.Serum potassium > 5.5 mmol/L
- •12.Pregnancy or breast feeding
- •13.Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomized partner.
- •14.Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 30 days
- •15.Any elective surgery during study participation
- •16.Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit
- •17.History of pancreatitis
- •18.History of dehydration, pre-coma diabeticum or diabetic ketoacidosis
- •19.Acute or scheduled investigation with iodine containing radiopaque material
- •20.Uncontrolled unstable angina pectoris
- •21.History of pericarditis, myocarditis, endocarditis
- •22.Recent pulmonary embolism
- •23.Hemodynamic relevant aortic stenosis
- •24.Aortic aneurysm
- •25.Regular use of NSAID’s (no acute use of NSAID within 48 hours before V2,V4,V5)
- •26.Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
- •27.History of 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 hematological disease as judged by the investigator
- •28.Lactose intolerance
- •29.Intake of Coumarin or coumarin derived compounds such as phenprocoumon (Marcumar) or warfarin (Coumadin, Warfant)
研究者
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