A study to evaluate efficay and safety of G-Pen compared to GLUCAGEN® HYPOKIT®

Phase 1

• Conditions: treatment of severe hypoglycemia; MedDRA version: 20.1 Level: LLT Classification code 10021005 Term: Hypoglycemia System Organ Class: 100000004861; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2018-002661-19-DE
• Lead Sponsor: Xeris Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 122

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified