G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes

Completed · Phase 3

Conditions studied: Insulin Hypoglycemia, Type 1 Diabetes Mellitus, Severe Hypoglycemia

In brief

This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen glucagon 1 mg during one period and Novo Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of severe hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose \< 54 mg/dL (3 mmol/L) is verified, the subject is administered a dose of G-Pen or Novo Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of \>70.0 mg/dL (3.89 mmol/L) or an increase of \> 20 mg/dL (\>1.11 mmol/L) within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedures are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug.

Key facts

Study ID

NCT03738865

Run by

Xeris Pharmaceuticals

People needed

132

Starts

2018-09-27

Expected to finish

2019-04-02

Last updated by the study team

2020-05-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and non-pregnant females diagnosed with type 1 diabetes (T1D) for at least 24 months.
• Current usage of daily insulin treatment that includes having an assigned "correction factor" for managing hyperglycemia.
• Age 18 to 75 years, inclusive.
• Random serum C-peptide concentration < 0.6 ng/mL.
• Willingness to follow all study procedures, including attending all clinic visits.
• Subject has provided informed consent as evidenced by a signed and dated informed consent form (ICF) completed before any trial-related activities occur.

You may not qualify if…

• Pregnancy
• Glycated hemoglobin (HbA1c) > 10% at Screening.
• Body mass index (BMI) > 40 kg/m2.
• Renal insufficiency (serum creatinine greater than 3.0 mg/dL) or end-stage renal disease requiring renal replacement therapy.
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or greater than 3 times the upper limit of normal.
• Hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL.
• Hematocrit < 30%.
• 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.
• Clinically significant electrocardiogram (ECG) abnormalities.
• Use of total insulin dose per day > 2 U/kg.
• Inadequate venous access.
• Congestive heart failure, New York Heart Association (NYHA) class III or IV.
• History of myocardial infarction, unstable angina, or revascularization within the past 6 months.
• History of a cerebrovascular accident in the past 6 months or with major neurological deficits.
• 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.
• Major surgical operation within 30 days prior to Screening.
• Current seizure disorder (other than with suspect or documented hypoglycemia).
• Current bleeding disorder, treatment with warfarin, or platelet count below 50 × 109 per liter.
• History of pheochromocytoma or disorder with increased risk of pheochromocytoma (multiple endocrine neoplasia type 2 (MEN 2), neurofibromatosis, or Von Hippel-Lindau disease).
• History of insulinoma.
• 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.
• History of glycogen storage disease.
• 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.
• Active substance other than tetrahydrocannabinol (THC) or alcohol abuse (more than 21 drinks per week for male subjects or 14 drinks per week for female subject).
• Administration of glucagon within 7 days of Screening.

Where it is running

• Diablo Clinical Research — Walnut Creek, California, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• PPD-Las Vegas Clinical Research Unit — Las Vegas, Nevada, United States
• Rainier Research Center — Renton, Washington, United States
• Medizinische Universität Graz-Center for Medical Research — Graz, Austria
• LMC Diabetes & Endocrinology — Toronto, Ontario, Canada
• AltaSciences — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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