NCT01000922已完成2 期
A Single Center, Randomized, Open-Label, Crossover Study, Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro Either in Combination With a Basal Insulin Infusion or With Insulin Glargine Relative to a Standardized Meal in Patients With Type 1 Diabetes
Biodel1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments
研究概览
简要总结
Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of type 1 diabetes for not less than 5 years
- •HbA1c values of not more than 9%
- •Age: 19 to 70 years
- •Sex: Male or Female
- •Body Mass Index: 18 - 28 kg/m2
- •Informed consent must be obtained in writing for all volunteers.
排除标准
- •Type 2 Diabetes mellitus.
- •History of hypersensitivity to any of the components in the study medication.
- •History of severe or multiple allergies.
- •Treatment with any other investigational drug in the last 1 month before study entry.
- •Treatment with any concomitant medication that in the judgment of the investigator. would interfere with the study results.
- •Progressive disease likely to prove fatal (e.g. malignancies).
- •Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
- •Having a significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator.
- •Blood donation within the last 30 days.
- •A women who is lactating.
- •Pregnant women or women intending to become pregnant during the study.
- •A sexually active woman of childbearing age not actively practicing birth control by using a medically accepted device or therapy.
- •Positive Serology for HIV, Hepatitis B or Hepatitis C.
- •Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the investigator.
- •A lack of compliance or other reasons which, in the opinion of the investigator, prevent the participation of the subject in the study.
研究组 & 干预措施
Regular Human Insulin
Experimental
Single injection
干预措施: Regular Human Insulin (Drug)
Lispro
Experimental
Single injection
干预措施: Lispro (Drug)
VIAject
Experimental
Single injection
干预措施: VIAject (Drug)
VIAject 50%
Experimental
Single injection
干预措施: VIAject 50% (Drug)
VIAject/Insulin glargine
Experimental
Single injection
干预措施: VIAject/Insulin Glargine (Drug)
Insulin Glargine/VIAject
Experimental
Single injection
干预措施: Insulin Glargine/VIAject (Drug)
结局指标
主要结局
To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments
时间窗: 8 hours
次要结局
- To compare the ppGlucmax for all treatments, the ppTGluc-max, the AUCGluc 0-180 and the AUCGluc 0-360, CGluc-baseline for all treatments.(8 hours)
研究者
研究点 (1)
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