Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics

• Status: Completed
• Trial end date: 2017-09-25
• Target enrollment: 0
• Participant gender: All

Summary

This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for hypoglycemia rescue of adult patients with type 1 diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xeris Pharmaceuticals
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• diagnosed with type 1 diabetes mellitus for at least 24 months

• usage of daily insulin treatment

• random serum C-peptide concentration < 0.5 ng/mL

Exclusion Criteria:

• pregnant or nursing

• HbA1c >9.0%

• renal insufficiency

• hepatic synthetic insufficiency

• aspartate or alanine aminotransferase > 3 times the upper limit of normal

• hematocrit less than or equal to 30%

• use of > 2.0 U/kg total insulin dose per day

• inadequate bilateral venous access in both arms

• congestive heart failure, New York Heart Association class II, III or IV

• active malignancy within 5 years, except basal cell or squamous cell skin cancers

• history of breast cancer or malignant melanoma

• major surgical operation within 30 days

• current seizure disorder.

• current bleeding disorder, treatment with warfarin, or platelet count below 50,000

• history of pheochromocytoma or disorder with increased risk of pheochromocytoma

• history of insulinoma

• history of glycogen storage disease.

• positive for HIV, hepatitis C virus or active hepatitis B virus infection

• whole blood donation of 1 pint (500 mL) within 8 weeks

• active substance or alcohol abuse

• administration of glucagon within 28 days

• participation in other studies involving an investigational drug or device within 30 days