EUCTR2009-016164-36-DE进行中（未招募）不适用
A mono-center, open label, randomised 2-period crossover study to compare the pharmacokinetics and pharmacodynamics of continuous insulin infusion administered either intradermally or subcutaneously in subjects with type 1 diabetes mellitus
Becton, Dickinson and Company, BD Technologies0 个研究点开始时间: 2009年11月9日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •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 subject)
- •Type 1 Diabetes mellitus, according to clinical judgment / ADA / WHO-definition (Diabetes Care 2003; 26: 5-20) for at least 1 year
- •Current treatment: Insulin Pump
- •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? 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
- •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, subjects 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.
- •Donation of any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening
- •Subjects with a history of deep leg vein thrombosis or with frequent appearance of deep leg vein thrombosis in 1st degree relatives as judged by the investigator
研究者
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