EUCTR2007-006231-31-DE进行中（未招募）不适用
A mono center, open-label glucose clamp study examining the metabolic effect of the frequency of insulin infusion intervals for basal insulin infusion in patients with type 1 diabetes
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- Male
入选标准
- •Male patients will be included in the trial only, if they fulfill all of the inclusion criteria mentioned below:·Understood and signed informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the patient)·Type 1 Diabetes mellitus, according to clinical judgement / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20)·Current treatment: Intensified insulin therapy (also patients on continuous subcutaneous insulin infusion (CSII)) (max. total daily insulin dose <1.2 U/kg)· Age in the range of >18 and <65 years· Body mass index (BMI) <32 kg/m²·HbA1c <9.0 %Able and willing to adhere to the study procedures for the entire trial period· Negative test results for hepatitis C antibodies or hepatitis B surface antigen or HIV at screening.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will not be permitted to enter the trial, if they fulfill any of the exclusion criteria mentioned below:·Previous participation in this trial or participation in a clinical trial within 4 weeks prior to screening examination.·Proliferative retinopathy or maculopathy that has required acute treatment within the last six months·Acute and severe illness apart from diabetes mellitus as judged by the investigator·Abnormalities in the laboratory parameters if judged as clinically significant by the investigator (GOT / GPT> 2*ULN; creatinine clearance (Cockroft formula) <50 ml/h). In particular, patients with thrombocyte count <100/nL, INR >1.3, PTT >50 sec. will not be permitted to enter the study.·Clinically significant abnormalities in the ECG·Recurrent major hypoglycemia or hypoglycemic unawareness as judged by the investigator· Use of systemic corticoids for the last three month prior screening examination or treatment with medication known to interfere with glucose metabolism such as non-selective ß-blockers, or mono amine oxidase (MAO) inhibitors, ACE-inhibitors or thiazides, unless medical treatment having existed for at least three month prior screening examination.·Impaired hepatic or renal functions as judged by the investigator·Cardiac problems as judged by the investigator·Uncontrolled hypertension (treated or untreated) as judged by the investigator (RRsyst. >140 mmHg, RRdiast. > 90 mmHg)·Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation·Current addiction to alcohol or substances of abuse as determined by the investigator·Allergy to plaster.·Any other condition that the investigator feels would interfere with trial participation or evaluation of results
研究者
相似试验
已完成
不适用
An open-label, single centre study to assess and compare the intra- and interpatientvariability in the oral bioavailability for Immediate-Release Tacrolimus and after conversion to Modified-Release Tacrolimus in stable kidney transplant recipients.NL-OMON35391Interne Geneeskunde, onderafdeling Nefrologie40
已完成
1 期
To establish safety and performance of RespirAId R20 -mechanical ventilation device in PatientsCTRI/2020/10/028638Remidio Innovative Solutions Pvt Ltd5
已完成
不适用
To check the effect of mashadi taila with nagara choorna in shoulder pain.CTRI/2020/12/029872Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital30
已完成
Unknown
Effect of Takrarishta on Irritable Bowl SyndromeCTRI/2024/05/067261Bhimashankar Ayurved College12
已完成
不适用
A single centre, open label trial investigating the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjectsgroeihormoondeficientiegrowth hormone deficiencyNL-OMON42854ovo Nordisk A/S7