EUCTR2011-003733-34-DE进行中（未招募）不适用
Human Insulin Analogs: Evaluation of inflammatory mRNA expression of Macrophages and Endothelial function of Short-acting insulin – HERMES Pilot Study - HERMES study
ikfe – Institute for Clinical Research and Development0 个研究点目标入组 12 人开始时间: 2011年8月25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
- 入组人数
- 12
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. Type 2 diabetes mellitus
- •2. Stable BOT (basal oral therapy) with Insulin Glargine + = 1 OHA (oral hypoglycemic agent except for TZD) for a minimum of three months before entering the study
- •3. HbA1c = 8.5%
- •4. Age between 30 and 75 years inclusively
- •5. Body mass index = 40 kg/m2
- •6. Patient consents that his/her family physician 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Type 1 diabetes mellitus
- •2. Unspecific infection or inflammation (hsCRP >10mg/L in POC test)
- •3. Use of thiazolidinediones within the last 3 months prior to study start
- •4. Retinopathy, hepatic or renal dysfunction or clinically relevant other major diseases
- •5. History of drug or alcohol abuse within the last five years prior to screening
- •6. Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
- •7. History of severe or multiple allergies
- •8. Treatment with any other investigational drug within 3 months prior to screening
- •9. Progressive fatal disease
- •10. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.3 mg/dl in women and > 1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
- •11. Pregnant or lactating women
- •12. 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 vasectomized partner
- •13. Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
研究者
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Unknown
4 期
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