EUCTR2018-002661-19-AT进行中（未招募）1 期
G-PEN (GLUCAGON INJECTION) COMPARED TO GLUCAGEN® HYPOKIT® (GLUCAGON) FOR INDUCED HYPOGLYCEMIA RESCUE IN ADULTS WITH T1D: A PHASE 3 MULTI-CENTER, RANDOMIZED, CONTROLLED, SINGLE BLIND, 2-WAY CROSSOVER STUDY TO EVALUATE EFFICACY AND SAFETY
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 122
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
入选标准
- •1.Males and females diagnosed with T1D for at least 24 months. Women of childbearing potential require a negative urine pregnancy test and must use medically accepted contraception throughout the study and for 7 days after the last dose of study drug.
- •Nursing mothers will be allowed to participate in the study. However, breast feeding during the inpatient study visits (Visits 2 and 3) and for 48 hours after each dose of study drug is not allowed.
- •2.Current usage of daily insulin treatment that includes having an assigned correction factor” for managing hyperglycemia.
- •3.Age 18 to 75 years, inclusive.
- •4.Random serum C-peptide concentration < 0.6 ng/mL.
- •5.Subjects reporting active marijuana use or testing positive for tetrahydrocannabinol (THC) via rapid urine test will be allowed to participate in the study at the discretion of the Investigator.
- •6.Willingness to follow all study procedures, including attending all clinic visits.
- •7.Subject has provided informed consent as evidenced by a signed and dated informed consent form (ICF) completed before any trial-related activities occur.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Pregnancy
- •2.Glycated hemoglobin (HbA1c) > 10% at Screening.
- •3.Body mass index (BMI) > 40 kg/m2.
- •4.Renal insufficiency (serum creatinine greater than 3.0 mg/dL) or end-stage renal disease requiring renal replacement therapy.
- •5.Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or greater than 3 times the upper limit of normal.
- •6.Hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL.
- •7.Hematocrit < 30%.
- •8.Blood pressure (BP) readings at Screening where systolic blood pressure (SBP) < 90 or > 150 mm Hg, and diastolic blood pressure (DBP) < 50 or > 100 mm Hg.
- •9.Clinically significant ECG abnormalities.
- •10.Use of total insulin dose per day > 2 U/kg.
- •11.Inadequate venous access.
- •12.Congestive heart failure, New York Heart Association (NYHA) class III or IV.
- •13.History of myocardial infarction, unstable angina, or revascularization within the past 6 months.
- •14.History of a cerebrovascular accident in the past 6 months or with major neurological deficits.
- •15.Active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. Any history of breast cancer or malignant melanoma will be exclusionary.
- •16.Major surgical operation within 30 days prior to Screening.
- •17.History of or current seizure disorder (other than with suspect or documented hypoglycemia).
- •18.Current bleeding disorder, treatment with warfarin, or platelet count below 50 × 109 per liter.
- •19.History of pheochromocytoma or disorder with increased risk of pheochromocytoma (multiple endocrine neoplasia type 2 [MEN 2], neurofibromatosis, or Von Hippel-Lindau disease).
- •20.History of insulinoma.
- •21.History of allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products or to any of the excipients (dimethyl sulfoxide [DMSO] and trehalose) in the investigational formulation.
- •22.History of glycogen storage disease.
- •23.Subject tests positive for human immunodeficiency virus [HIV], hepatitis C virus [HCV], or hepatitis B virus [HBV] infection (hepatitis B surface antigen positive [HBsAg+]) at Screening.
- •24.Active substance other than THC or alcohol abuse (more than 21 drinks per week for male subjects or 14 drinks per week for female subject).
- •25.Administration of glucagon within 7 days of Screening.
- •26.Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before Screening for the current study and during participation in the current study.
- •27.Any other reason the Investigator deems exclusionary.
研究者
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