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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2017-09-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypoglycemia Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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G-Pen first, then Lilly Glucagon

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 \[rDNA origin\])

Group Type OTHER

G-Pen (glucagon injection)

Intervention Type DRUG

1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

Lilly Glucagon (glucagon injection [rDNA origin])

Intervention Type DRUG

1 mg of Lilly glucagon reconstituted from lyophilized powder

Lilly Glucagon first, then G-Pen

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)

Group Type OTHER

G-Pen (glucagon injection)

Intervention Type DRUG

1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

Lilly Glucagon (glucagon injection [rDNA origin])

Intervention Type DRUG

1 mg of Lilly glucagon reconstituted from lyophilized powder

Interventions

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G-Pen (glucagon injection)

1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

Intervention Type DRUG

Lilly Glucagon (glucagon injection [rDNA origin])

1 mg of Lilly glucagon reconstituted from lyophilized powder

Intervention Type DRUG

Other Intervention Names

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glucagon glucagon

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No