EUCTR2018-000892-33-DE进行中（未招募）1 期
A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with T1DM treated with insulin
Zealand Pharma A/S0 个研究点目标入组 42 人开始时间: 2018年7月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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
- •To be included in the trial, patients have to fulfill all of the following criteria:
- •1. Following receipt of verbal and written information about the trial, patient, parent(s) or guardian(s) of the patient must provide signed informed consent before any trial-related activity is carried out*
- •2. Female or male patients with T1DM for at least 1 year, diagnostic criteria as defined by the American Diabetes Association, and receiving daily insulin and in good and stable medical condition
- •3. At least 6.0 years of age (inclusive) and less than 18.0 years.
- •Germany only: A staggered approach” will be applied, whereby a positive safety assessment needs to be available for at least 10 patients who have completed the dosing visit in the overall trial before younger patients (6 to 11 years of age) may be enrolled.
- •4. Body weight =20 kg
- •5. Female patients must meet one of the following criteria:
- •a. Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening until last follow-up visit. An acceptable method of contraception includes at least one of the following:
- •i. Abstinence from heterosexual intercourse
- •ii. Systemic contraceptives (birth control pills, injectable/implant/ insertable hormonal birth control products, transdermal patch); if the participant is using systemic contraceptives, she must use an additional form of acceptable contraception (iii or iv, below)
- •iii. Intrauterine device (with and without hormones)
- •iv. Condom with spermicide
- •b. Participant is of non-childbearing potential due to pre-puberty status or a medical condition confirmed by the investigator
- •6. Male patients must meet the following criteria: If sexually active, uses condom and partner practices contraception during the trial from screening and until last follow-up visit
- •7. Willingness to adhere to the protocol requirements
- •* Informed consent signatures must be obtained according to local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients meeting any of the following criteria during screening evaluations will be excluded from trial participation:
- •1. Females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or are lactating
- •2. Known or suspected allergy to trial product(s) or related products
- •3. History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
- •4. Previous randomization in this trial
- •5. History of an episode of severe hypoglycemia that required a third party assistance within a month prior to screening visit
- •6. History of hypoglycemic events associated with seizures or hypoglycemia unawareness in the last year prior to screening
- •7. History of epilepsy or seizure disorder
- •8. Receipt of any investigational drug within 3 months prior to screening
- •9. Active malignancy within the last 5 years
- •10. Congestive heart failure, New York Heart Association class II-IV
- •11. Current bleeding disorder, including anti-coagulant treatment
- •12. Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor)
- •13. Use of a daily systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial
- •14. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 × the upper limit of the normal range (ULN), bilirubin >1.5 × ULN, estimated glomerular filtration rate <30 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease study definition, or altered electrolyte values of clinical relevance for cardiac conduction, as judged by the investigator
- •15. Clinically significant abnormal electrocardiogram (ECG) at screening as judged by the investigator
- •16. Clinically significant illness within 4 weeks before screening as judged by the investigator
- •17. Surgery or trauma with significant blood loss within the last 2 months prior to screening
- •18. Patients with mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of the investigator should not participate in the trial
- •19. Any condition interfering with trial participation or evaluation or that could be hazardous to the patient
- •20. The use of prescription or non-prescription medications known to cause QT prolongation.
- •In addition, the following exclusion criteria at clinic admission on Visit 2, day 0 apply at the time of admission to the clinic, which is the day before clamp procedure:
- •Patients who meet one or more of the following exclusion criteria at the time of admission to the clinic will be excluded from the dosing visit, however, the visit can be rescheduled 1-7 days later. The dosing visit can only be rescheduled once.
- •1. Atypically strenuous exercise within 4 days prior to dosing, as judged by the investigator. Exercise during the trial should follow patient’s typical routine, and should not exceed a near maximum intensity for more than 20 minutes per day, or moderate intensity for more than 90 minutes per day
- •2. Clinically significant illness within 4 weeks before dosing, as judged by the investigator
- •3. Consumption of alcohol within 24 hours prior to dosing visit, determined by positive results from an alcohol breath test
- •4. Not fasting from 22:00 hours the evening prior to dosing, apart from water.
- •5. The use of any non-prescribed systemic or topical medication, except routine vitamins
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