Assessment of Intranasal Glucagon in Children and Adolescents with Type 1 Diabetes : Phase 3 study

T1D Exchange Clinic Network Coordinating Center0 个研究点目标入组 48 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

暂无简介。

•1. History of type 1 diabetes and receiving daily insulin therapy from the time of diagnosis for at least 12 months.
•2.At least 4.0 years of age and less than 17.0 years.
•3.Females must meet one of the following criteria:
•a) Of childbearing potential but agrees to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from the screening visit until study completion).
•b) Of non-childbearing potential, defined as a female who has had a hysterectomy or tubal ligation, is clinically considered infertile or has not yet reached menarche.
•4. In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations.
•5. Willingness to adhere to the protocol requirements
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 48
•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

•1.Females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or are lactating.
•2.History of hypersensitivity to glucagon or any related products or 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.History of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
•5.History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the 1 month prior to enrolling in the study.
•6.Use of daily systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs.
•7.History of epilepsy or seizure disorder.
•8.Use of an Investigational Product in another clinical trial within the past 30 days
•9.Blood donation in 3 months prior to first glucagon dosing visit.

发起方

T1D Exchange Clinic Network Coordinating Center