EUCTR2011-001291-19-DE进行中（未招募）不适用
A phase IIa, double-blinded, randomized trial comparing the pharmacokinetics,pharmacodynamics and safety of BioChaperone® rhInsulin to fast-acting insulin analog in patients with Type 1 Diabetes mellitus
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Adocia SA
- 入组人数
- 20
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
- All
入选标准
- •Male and female subjects.
- •2.Age: 18 –50 years.
- •3.Diabetes mellitus type 1 (with intensified insulin therapy or pump therapy) (C-Peptide < 1 ng/mL)
- •4.BMI 18-29 kg/m2
- •5. HbA1c < 8.5 %
- •6.Informed consent must be obtained for all volunteers in writing
- •7.Subject consents that his family physician will be informed of trial participation
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Diabetes mellitus 2
- •2. Poor glycemic control or recent changes (within 3 months) in baseline diabetes treatment
- •3.History of hypersensitivity to the study drugs or to drugs with similar chemical structures
- •4.History of severe or multiple allergies
- •5.Evidence of severe secondary complications of diabetes (neuropathy, nephropathy or proliferative retinopathy, macro and micro-angiopathies) as judged by investigator
- •6.Any systemic treatment with drugs known to interfere with glucose metabolism , and diabetes progression such as systemic or local corticoids, non-selective beta-blockers, and monoamine oxidase (MAO) inhibitors within 3 months prior to randomization
- •7.Blood donation within the last 3 months.
- •8.Excessive physical activities in the last 24 hrs before the dosing visits.
- •9.History of drug or alcohol abuse within the last five years prior to screening.
- •10.Treatment with any other investigational drug within 3 months prior to screening.
- •11.Progressive fatal disease.
- •12.History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine >1.5 mg/dl in men and > 1.1 mg/dl in female), uncontrolled cholesterol (LDL>1g/L) neurological, psychiatric and/or hematological disease as judged by the investigator.
- •13.Uncontrolled hypertension (HTA>140/80mm Hg)
- •14.HIV1, HIV2, Hepatitis B, Hepatitis C positive.
- •15.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.
- •16.Pregnancy or breast feeding
- •17.Lack of compliance or other similar reason that according to investigator precludes satisfactory participation in the study
- •18. History or evidence of use of any tobacco – or nicotine-containing product within 6
- •months of screening
- •19. Clinical or surgical scares in the intended abdominal region
- •20. Daily insulin requirement (> 60 IU)
- •21. Patients with increased thrombosis risk
研究者
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