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

NCT02656069 | Completed Phase 3 Results FDA Drug

• 1 other identifier: XSGP-301
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

• Hypoglycemia Rescue: Intent-to-Treat Population

  Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon

  At 30 minutes following administration of study drug

• Hypoglycemia Rescue: Per Protocol Population

  Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon

  At 30 minutes following administration of study drug

• Hypoglycemia Rescue: Alternate Glucose Response Definition

  Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or an increase in from baseline in plasma glucose concentration of at least 20 mg/dL within 30 minutes after administration of glucagon

  At 30 minutes following administration of study drug

Secondary Outcomes (6)

• Plasma Glucose Area Under the Curve (AUC)

  At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon

• Plasma Glucose Maximum Concentration (Cmax)

  At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon

• Plasma Glucose Time to Maximum Concentration (Tmax)

  At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon

• Plasma Glucose Time to Concentration > 70 mg/dL

  At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon

• Time to Resolution of Hypoglycemia Symptoms

  At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon

Study Arms (2)

G-Pen first, then Lilly Glucagon

OTHER

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 \[rDNA origin\])

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

Lilly Glucagon first, then G-Pen

OTHER

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)

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

Interventions

G-Pen (glucagon injection) DRUG

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

Also known as: glucagon

G-Pen first, then Lilly Glucagon; Lilly Glucagon first, then G-Pen

Lilly Glucagon (glucagon injection [rDNA origin]) DRUG

1 mg of Lilly glucagon reconstituted from lyophilized powder

Also known as: glucagon

G-Pen first, then Lilly Glucagon; Lilly Glucagon first, then G-Pen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Xeris Pharmaceuticals: lead

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

ProSciento, Inc.

Chula Vista, California, 91911, United States

Location

AMCR Institute

Escondido, California, 92025, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Rainier Research

Renton, Washington, 98057, United States

Location

LMC Diabetes & Endocrinology

Toronto, Ontario, M4G 3E8, Canada

Location

Related Publications (1)

• Christiansen MP, Cummins M, Prestrelski S, Close NC, Nguyen A, Junaidi K. Comparison of a ready-to-use liquid glucagon injection administered by autoinjector to glucagon emergency kit for the symptomatic relief of severe hypoglycemia: two randomized crossover non-inferiority studies. BMJ Open Diabetes Res Care. 2021 Oct;9(1):e002137. doi: 10.1136/bmjdrc-2021-002137.

  PMID: 34620618 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Martin J. Cummins, VP, Clinical Development
• Organization: Xeris Pharamaceuticals, Inc.

mcummins@xerispharma.com

806-282-2120

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 14, 2016
• Study Start: March 15, 2017
• Primary Completion: August 14, 2017
• Study Completion: September 25, 2017
• Last Updated: October 30, 2018
• Results First Posted: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); CA (1)