EUCTR2006-006599-39-DE进行中（未招募）不适用
An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAJECT™ and Regular Human Insulin 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
- BIODEL Inc.
- 入组人数
- 400
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
- •1. Established diagnosis of type 1 diabetes for more than 1 year as defined
- •in section 3.4. of the study protocol
- •2. HbA1c values of not more than 10.5%
- •3. Three months on a stable insulin regimen that meets the current standard of care
- •and that includes at least two daily insulin injections
- •4. Age: 18 to 70 years
- •5. Body Mass Index: 18 - 38 kg/m2
- •6. Informed consent must be obtained in writing for all patients
- •7. Patients which are trained in intensified insulin therapy
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Type 2 diabetes mellitus as determined by the investigator
- •2. History of frequent severe hypoglycemia within the prior six months
- •3. C-peptide > 1,0 ng/ml
- •4. History of known hypersensitivity to any of the components in the study
- •5. History of severe or multiple allergies
- •6. Treatment with any diabetes-related investigational drug in the last 3 months before study entry or treatment with any non-diabetes related investigational drug within the last 30 days before study entry
- •7. Current treatment with systemic oral, injected, or inhaled corticosteroids
- •8. Progressive disease likely to prove fatal
- •9. History of malignancy within the past 5 years except for basal cell epithelioma
- •10. Known significant hepatic disease or serum AST or ALT values =3 X upper limit of
- •normal or bilirubin levels = 1.5 X upper limit of normal
- •11. Severe complications of diabetes mellitus including a history or finding of Stage
- •III or IV diabetic retinopathy, proteinuria > 2+ by urine dipstick, serum creatinine
- •of >1.8 mg/dl for males or >1.5 mg/dl for females, history of renal transplant,
- •severe peripheral vascular disease which has resulted in amputation, chronic
- •foot ulcers claudication or absent pedal pulses
- •12. Known history of autonomic neuropathy
- •13. History of moderate to severe ketoacidosis within the 3 months preceding
- •screening for the study
- •14. Current drug or alcohol abuse, or a history which in the opinion of the
- •Investigator will impair patient safety or protocol compliance.
- •15. Current significant cardiovascular, respiratory, gastrointestinal, hepatic, renal,
- •neurological, psychiatric and/or hematological disease as evaluated by the
- •Investigator
- •16. Blood donation within the last 30 days
- •17. A woman who is breast feeding
- •18. Pregnant women or women intending to become pregnant during the study
- •19. A sexually active woman of childbearing age not actively and consistently
- •practicing birth control by using a medically accepted device or therapy
- •20. Abnormal ECG, safety lab or physical examination results which, in the opinion of
- •the investigator, render the participation of the patient in the study to be
- •inappropriate or unsafe
- •21. A history of lack of compliance with medical instructions, recent drug or alcohol
- •abuse, or other reasons which, in the opinion of the investigator, render the
- •participation of the patient in the study to be inappropriate or unsafe
- •22. Patients with diabetes mellitus Type 1 utilizing insulin pumps
- •23. Current significant diseases of the adrenal gland, pituitary gland and thyroid gland at the discretion of the investigator
- •24. Glomerular Filtration Rate < 40ml/min
研究者
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