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

Completed · Phase 3

Conditions studied: Hypoglycemia, Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT02656069

Run by

Xeris Pharmaceuticals

People needed

80

Starts

2017-03-15

Expected to finish

2017-09-25

Last updated by the study team

2018-10-30

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• ProSciento, Inc. — Chula Vista, California, United States
• AMCR Institute — Escondido, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• Rainier Research — Renton, Washington, United States
• LMC Diabetes & Endocrinology — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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