Effect of Prandial Treatment With Insulin Glulisine Compared to Regular Human Insulin on Postprandial Endothelial Function and Microvascular Stress in Type 2 Diabetic Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin
研究概览
简要总结
The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin.
The secondary objectives are to evaluate the postprandial time course of the following efficacy parameters after injection of insulin glulisine compared with regular insulin on
- Blood Glucose
- Insulin
- Intact proinsulin
- Asymmetric dimethylarginine (ADMA)
- Metal matrix proteasis (MMP-9)
- Oxidative status (per ox)
- Interleukin 18 (IL-18)
- Free fatty acids (FFA)
- Oxidised LDL (ox-LDL)
- Microvascular blood circulation measured with laser Doppler at 37 °C (LDF37)
- Microvascular blood circulation measured with laser Doppler at 44 °C (LDF44)
详细描述
Phase III b Indication Type 2 Diabetes Trial Objectives 1) Primary objective: The primary objective of the study is to evaluate the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin. 2) Secondary objectives: The secondary objectives are to evaluate the postprandial time course of blood glucose, insulin, intact proinsulin, asymmetric dimethylarginine (ADMA), metal matrix proteasis (MMP-9), free fatty acids (FFA), oxidised LDL (ox-LDL), oxidative status (per ox), IL-18 as well as postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C (LDF37) and 44 C (LDF44).
Efficacy Variables Primary efficacy variablePostprandial time course of nitrotyrosineSecondary efficacy variablePostprandial time course of glucose, insulin, intact proinsulin, ADMA, MMP-9, FFA, ox-LDL, per-ox, and IL-18 as well as postprandial time course of laserdopplerflux at 37 °C and 44 °C Safety Variables Incidence and frequency of adverse events and evaluation of safety laboratory parameters Medication/Dosage Insulin glulisine, dose 0.10 U/kg and Regular Human Insulin, dose 0.10 U/kg Study Duration Duration of study participation for one patient: 5 - 43 days Overall duration of the study: 6 months Design Single-centre, open label, randomized, 2-way-crossover trial Population Male and female type 2 diabetic patients between 40 and 70 years with HbA1c between 6.5 % and 9.9 % and treated with sulfonyurea alone or in combination with Metformin in a stable dosage within the last 3 months Sample Size N = 15
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes mellitus according to the ADA criteria
- •HbA1c between 6.5 % and 9.9 %
- •Monotherapy with sulfonylurea or combined with Metformin in a stable dosage within the last 3 months
- •Age between 40 and 70 years
排除标准
- •Type 1 Diabetes mellitus
- •Pre-Treatment with insulin within the last 6 months prior to screening
- •Treatment with glitazones within the last 6 months prior to screening
- •Pre-Treatment with PPARy-agonists, glinides or glucosidase inhibitors within the last 4 weeks prior to screening
- •Untreated hypertension stage II-III according to WHO criteria
- •Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
- •Total Cholesterol > 300 mg/dl (anamnestically)
- •Hypokalemia (K < 3.5 mmol /l)
- •Major micro- or macrovascular complications as judged by the investigator
- •Tobacco use within the last 12 months prior to screening
- •Drugs with major impact on endothelial function like nitrates etc.
- •History of drug or alcohol abuse within the last five years prior to screening
- •Anamnestic history of hypersensitivity to the study drugs 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
- •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, > 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator
- •Pregnancy or breast feeding
- •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
- •Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study
研究组 & 干预措施
1
One Day Treatment with Insulin Glulisine
干预措施: Insulin Glulisine (Drug)
2
One day Treatment with Human insulin
干预措施: Insulin (Drug)
结局指标
主要结局
the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin
时间窗: 1 day
次要结局
- postprandial time course of blood glucose, insulin, intact proinsulin, ADMA, MMP-9, FFA, ox-LDL, per ox Status, IL-18, postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C and 44 C(1 day)