Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Nitrotyrosine
研究概览
简要总结
The planned HERMES study is to investigate and compare the effects of Insulin Glulisine, Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and several clinical and laboratory markers of postprandial endothelial cell function, sub-clinical inflammation and cardiovascular risk in patients with type 2 DM. The primary parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a biomarker for oxidative stress. As vascular data on Insulin Glulisine vs. Insulin Aspart are missing, it is not possible to calculate sample size and statistical power. Therefore the goal of the HERMES-Pilot-Study is to generate preliminary data for statistical considerations and estimations on the probability of success of HERMES.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Stable BOT (basal oral therapy) with Insulin Glargine + ≥ 2 OHA (oral hypoglycemic agents except for TZD) for a minimum of three months before entering the study
- •HbA1c ≤ 8.5%
- •Age between 30 and 75 years inclusively
- •Body mass index ≤ 40 kg/m2
- •Patient consents that his/her family physician will be informed of trial participation
排除标准
- •Type 1 diabetes mellitus
- •Unspecific infection or inflammation (hsCRP >10mg/L in POC test)
- •Use of thiazolidinediones within the last 3 months prior to study start
- •Retinopathy, hepatic or renal dysfunction or clinically relevant other major diseases
- •History of drug or alcohol abuse within the last five years prior to screening
- •History of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
- •History of severe or multiple allergies
- •Treatment with any other investigational drug within 3 months prior to screening
- •Progressive fatal disease
- •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
- •Pregnant or lactating women
- •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
- •Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
研究组 & 干预措施
Insulin Glulisine: bolus injections before each main meal
Patients are already on an Insulin Glargine therapy when they start and will them after randomization receive additionally Insulin Glulisine bolus injections before each of the main meals.
干预措施: Insulin glulisine (Drug)
Insulin Aspart: bolus injections before each main meal
Patients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally Insulin Aspart bolus injections before each of the main meals.
干预措施: Insulin aspart (Drug)
Regular human insulin:bolus injections before each main meal
Patients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally regular human insulin bolus injections before each of the main meals.
干预措施: Regular human insulin (Drug)
结局指标
主要结局
Nitrotyrosine
时间窗: Baseline, after 10 weeks, after 24 weeks
The difference in the percent increase of the oxidative stress biomarker nitrotyrosine after stimulation with a standardized meal
次要结局
- Skin blood flow(Baseline, after 10 weeks, after 24 weeks)
- HbA1c(Baseline, after 10 weeks, after 24 weeks)
- Hypoglycemic events(Baseline, after 10 weeks, after 24 weeks)
- intact Proinsulin(Baseline, after 10 weeks, after 24 weeks)
- Fasting blood glucose(Baseline, after 10 weeks, after 24 weeks)
- mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9)(Baseline, after 10 weeks, after 24 weeks)
- Insulin(Baseline, after 10 weeks, after 24 weeks)
研究者
Marcus Borchert
Thomas Forst, MD PhD, ikfe GmbH, Clinic
ikfe-CRO GmbH