A multiple center, open label, prospective, observational study to evaluate the effectiveness and ease-of-use of AMG504-1 administered in the home or school environments for treating hypoglycemia in children and adolescents with type 1 diabetes (T1D)

ocemia Solutions ULC0 个研究点目标入组 30 人开始时间: 2015年9月18日最近更新: 2015年9月21日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 30

研究概览入排标准研究者记录与标识符相似试验

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

•Child/Adolescent with diabetes (C/AWD) and their caregiver(s) meeting all of the following criteria will be considered for enrollment in the study:
•1. Availability for the entire study period.
•2. Motivated C/AWD and caregiver(s) and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the qualified investigator or designee.
•3. C/AWD lives with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia.
•4. Male or female C/AWD with a history of type 1 diabetes >1 year.
•5. C/AWD aged of at least 4 years of age but less than 18 years.
•6. A female C/AWD must meet one of the following criteria:
•a) Participant is of child-bearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the study (from the pre-trial evaluation and enrollment visit until study completion). An acceptable method of contraception includes one of the following:
•Abstinence from heterosexual intercourse
•Systemic contraceptives (birth control pills, injectable/implantable/ insertable hormonal birth control products, transdermal patch)
•Intrauterine device
•Condom with spermicide
•b) Participant is of non-child-bearing potential, defined as a female who had a hysterectomy or tubal ligation, is clinically considered infertile or has not yet reached menarche.
•7. In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a suitable candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations.
•8. Willingness to adhere to the protocol requirements.
•The informed consent form must be signed by all C/AWD (as applicable) and primary caregiver(s), prior to their participation in the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) no
•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

•C/AWD presenting any of the following will not be included in the study:
•1. Females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or lactating.
•2. History of significant hypersensitivity to glucagon, or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs.
•3. Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the investigator could interfere with the absorption, distribution, metabolism or excretion of drugs or could potentiate or predispose to undesired effects.
•4. Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
•5. Use of daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.
•6. Concomitant maintenance therapy with any drug that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor.
•7. Regular consumption of 3 or more units of alcoholic beverages per day.
•8. Current participation in another clinical trial, intent to enroll in another clinical trial during this clinical study or use of an Investigational Product (in another clinical trial) within the prior 30 days.
•Participants will be allowed to receive investigational treatment in this study more than once.

研究者

发起方

ocemia Solutions ULC

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