Prospective influence of bedtime insulin glargine on mobilization and function of endothelial progenitor cells in patients with type 2 diabetes: a partially double-blind, randomized, three-arm unicenter study - Glargine and EPC

niversity Hospital of Heidelberg0 个研究点开始时间: 2007年2月1日最近更新: 2013年5月6日

适应症

试验速览

暂无简介。

•-Type 2 Diabetes
•-Oral antidiabetic therapy
•-Age 35 – 70
•-6,5%< HbA1c = 9%
•-Ability of subject to understand character and individual consequences of clinical trial
•-Written informed consent must be available before enrollment in the trial
•-For women with childbearing potential, adequate contraception (Pearl Index < 1%, e.g. birth control pill) and negative blood pregnancy test
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years)
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•- Malignant disease
•- Hematopoietic disorders
•- Impairment of renal function (Serum creatinine > 1,5mg/dl)
•- autoimmune disease
•- treatment with immunosuppressive drugs
•- Psychiatric disease
•- Myocardial ischemia during previous 6 month
•- Acute coronary syndrome
•- pAVK IIb, III, IV (Fontaine-Ratschow)
•- Erythropoietin treatment
•- Glitazone treatment during two weeks before inclusion
•- Pregnancy and lactation
•- History of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product
•- participation in other clinical trials and observation period of competing trials, respectively
•- No subject will be allowed to enroll in this trial more than once

发起方

niversity Hospital of Heidelberg