Clinical Trial Details

NCT ID: NCT02656069
Date Last Changed: May 24, 2017

Overview

Research Study Summary

A clinical research study of G-Pen™ (glucagon injection) and Lilly Glucagon (glucagon injection [rDNA origin]) for the treatment of Hypoglycemia or Diabetes Mellitus, Type 1

Research Study Title

G-Pen™ (Glucagon Injection) Compared to Lilly Glucagon (Glucagon for Injection [RDNA Origin]) for Induced Hypoglycemia Rescue in Adult Patients With T1DM: A Phase 3, Multi-center, Randomized, Blinded, 2-Way Crossover Study to Evaluate Efficacy and Safety

Purpose

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 to 75 Years
Overall Status
Recruiting
Lead Sponsor
Xeris Pharmaceuticals
Duration
6 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 75 Years

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

Site Locations (7)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35294 University of Alabama at Birmingham
Tammy Wilson, RN
205-934-4112
tlperkins@uabmc.edu

Fernando Ovalle, MD
Principal Investigator
United States California Chula Vista 91911 ProSciento, Inc.
Paula Guzman
619-427-1300
paula.guzman@prosciento.com

Robert Peters, MD
Principal Investigator
United States California Escondido 92025 AMCR Institute
Laura Bedolla
760-466-1523
Lbedolla@amcrinstitute.com

Timothy Bailey, MD
Principal Investigator
United States California Walnut Creek 94598 Diablo Clinical Research
Emily Galdes
925-930-7267
egaldes@diabloclinical.com

Mark Christiansen, MD
Principal Investigator
United States Texas San Antonio 78229 Clinical Trials of Texas, Inc.
Angelica Guerrero, BS
210-949-0122
aguerro@cttexas.com

Douglas Denham, DO, CPI
Principal Investigator
United States Washington Renton 98057 Rainier Research
Kristen Hughes
425-251-1720
rcrc@rainier-research.com

Leslie Klaff, MD, PhD
Principal Investigator
Canada Ontario Toronto M4G 3E8 LMC Diabetes & Endocrinology
Nazneen Qureshi
866-701-3636 ext. 9310
research@lmc.ca

Ronnie Aronson, MD
Principal Investigator

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