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

Xeris Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hypoglycemia; Diabetes Mellitus, Type 1

Treatments: Drug: G-Pen (glucagon injection); Drug: Lilly Glucagon (glucagon injection [rDNA origin])

Study type: Interventional

Funder types: Industry

Identifiers

NCT02656069

XSGP-301

Details and patient eligibility

About

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.

Full description

This is a blinded, randomized, Phase 3 comparative efficacy and safety study in adults with type 1 diabetes. Patients will complete screening procedures up to 60 days before randomization to determine eligibility before enrollment to the treatment phase.

The procedure for evaluating the efficacy of the G-Pen (glucagon injection) consists of inducing hypoglycemia by intravenous administration of regular insulin diluted in normal saline. Each participant will undergo two episodes of insulin-induced hypoglycemia, and in random order will receive 1 mg G-Pen (glucagon injection) during one episode and 1 mg Lilly Glucagon during the other episode. There will be wash out period of 7-28 days between treatment visits.

Blood glucose levels will be monitored post-dosing, with a return of plasma glucose to a concentration > 70 mg/dL within 30 minutes signifying successful hypoglycemia rescue. As a confirmation of efficacy, subjects will complete a questionnaire concerning changes in symptoms of hypoglycemia following treatment with glucagon.

Subjects will return for a follow-up safety visit 3-14 days following administration of the final dose of glucagon.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

G-Pen first, then Lilly Glucagon

Other group

Description:

A single 1 mg subcutaneous (SC) injection of G-Pen (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection \[rDNA origin\])

Treatment:

Drug: Lilly Glucagon (glucagon injection [rDNA origin])

Drug: G-Pen (glucagon injection)

Lilly Glucagon first, then G-Pen

Other group

Description:

A single 1 mg SC injection of Lilly Glucagon (glucagon injection \[rDNA origin\]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen (glucagon injection)

Treatment:

Drug: Lilly Glucagon (glucagon injection [rDNA origin])

Drug: G-Pen (glucagon injection)