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-AT

Lead Sponsor: Xeris Pharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

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.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

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 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to demonstrate that G-Pen 1 mg (test) is not inferior to GlucaGen Hypokit 1 mg (reference), in Type 1 diabetic (T1D) subjects in a state of insulin-induced hypoglycemia. ;Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability of G-Pen 1 mg versus GlucaGen Hypokit 1 mg in the study population.;Primary end point(s): For the primary endpoint, groups will be compared for rates of achieving a positive plasma glucose response, defined as either a plasma glucose concentration > 70 mg/dL (> 3.88 mmol/L) or an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) within 30 minutes of study drug injection. ;Timepoint(s) of evaluation of this end point: during the trial

Secondary Outcome Measures

Name	Time	Method

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