EUCTR2007-003924-39-DE进行中（未招募）不适用
A mono center, open-label, randomized study examining the effects of intra-dermal vs. subcutaneous application of regular human insulin or rapid-acting insulin analogue on postprandial glycemic excursions 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）
- 入组人数
- 30
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 judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year, and less than 15 years
- •·Current treatment: Intensified insulin therapy (MDI or CSII)
- •·Age in the range of =18 and =55 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, hepatitis B surface antigen and HIV at screening.
- •Are the trial subjects under 18?
- •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)
- •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 3 months prior screening examination
- •·Any symptoms suggestive of, or a diagnosis or treatment for, gastroparesis
- •·Abnormalities in renal function (e.g. serum creatinine >1.2 mg/dl) or judged by the investigator that would pose a problem of clearance of injected insulin
- •·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. In particular, patients with GOT/GPT >3x, 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
- •·Lipodystrophy which in the judgment of the investigator would pose a problem in terms of variability of absorption of injected insulin
- •·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
- •·Any disease requiring use of anti-coagulants
- •·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/adhesive
- •·Any other condition that the investigator feels would interfere with trial participation or evaluation of results.
研究者
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