EUCTR2009-013264-39-DE进行中（未招募）不适用
A Single-Center, Double Blind, Randomized Crossover Study Evaluating Injection Site Toleration of VIAject® 7, VIAject® 25 and Insulin Lispro in Subjects with Type 1 or Type 2 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.
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. Age 18-70 years
- •2. Body Mass Index 18-37 kg/m2
- •3. Males or females diagnosed with type 1 or 2 diabetes mellitus for at least 1 year
- •4. Subject must usually self-inject both basal and meal-time insulin injections to
- •control diabetes (at least 2 injections/day) and must have done so for at least 3
- •months prior to the study.
- •5. The usual short- or fast- (rapid) acting insulin dose for the meal to be studied
- •must be between 5 and 25 units inclusive.
- •6. Signed and dated informed consent obtained before any trial-related activities.
- •(Trial-related activities are any procedure that would not have been performed
- •during normal management of the subject.).
- •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. HbA1c value of > 10.0%
- •2. History of hypersensitivity to any of the components in the study medication
- •3. History of insulin allergy
- •4. Treatment with any other investigational drug in the last 3 months before study
- •5. Treatment with oral or parenteral corticosteroids at the time of screening or
- •anticipated use during the course of the study.
- •6. Regular use of analgesics (Daily doses of up to 100 mg aspirin are acceptable)
- •7. Any chronic pain syndrome, e.g., chronic neuropathic pain, fibromyalgia, etc.
- •8. Progressive disease likely to prove fatal (e.g., malignancies)
- •9. Current drug or alcohol use, positive recreational drug screen or a history of drug
- •or alcohol abuse which in the opinion of the investigator will impair subject safety
- •or protocol compliance or assessment of injection site discomfort.
- •10. Significant cardiovascular, respiratory, gastrointestinal, hepatic, renal,
- •neurological, psychiatric and/or hematological disease as evaluated by the
- •investigator
- •11. Clinically significant abnormal hematology or biochemistry screening tests, as
- •judged by the investigator. In particular, subjects with elevated liver enzymes
- •(AST or ALT > 3 times the upper limit of normal) or impaired renal function
- •(elevated serum creatinine values > 1.5 times the upper limit of normal) will not
- •be allowed to enter the trial.
- •12. A woman who is lactating
- •13. Pregnant women or women intending to become pregnant during the study
- •14. A sexually active woman - not using adequate contraceptive methods (adequate
- •contraceptive measures include: implants, injectables, combined oral
- •contraceptives, hormonal IUD, sexual abstinence or vasectomised partner).
- •15. Abnormal ECG, safety lab or physical examination results that are deemed
- •clinically significant by the investigator
- •16. Lack of understanding of pain scales or other aspects of the study.
- •17. Lack of compliance or other reasons which, in the opinion of the investigator,
- •prevent the participation of the subject in the study
- •18. Subjects who have been dosed with study drug in any previous VIAject® clinical
- •19. Positive serology for HIV, hepatitis B, or hepatitis C.
研究者
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