EUCTR2018-002661-19-DE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. Willingness to follow all study procedures, including attending all clinic visits.
- •6. 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 40
- •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 Stage 2 or greater kidney failure.
- •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 electrocardiogram (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 II, III or IV.
- •13. History of myocardial infarction, unstable angina, or revascularization within the past 6 months.
- •14. History of a cerebrovascular accident 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 (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 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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