G-Pen™ for Hypoglycemia Rescue in T1D Patients

G-Pen™ (Glucagon Injection) for Induced Hypoglycemia Rescue in Adult Patients With T1D

This is an open-label, exploratory pilot study in patients with T1D. The study will involve two daytime clinical research center visits 7-14 days apart. Subjects will receive a single injection of G-Pen™ (glucagon injection) at each visit.

Study Overview

• Status: Completed
• Conditions: Hypoglycemia
• Intervention / Treatment: Drug: Glucagon

Detailed Description

Following eligibility confirmation, each study participant will undergo two episodes of insulin-induced hypoglycemia with plasma glucose < 50 mg/dL. Both episodes will be treated with a single subcutaneous injection of G-Pen™ glucagon. For the first treatment visit, all subjects will receive a 1 mg dose of G-Pen™ glucagon. The investigator will have discretion to repeat this same dose at the second treatment visit or give a 0.5 mg dose of G-Pen™ glucagon. A follow-up phone call will be conducted 3-7 days following administration of the final dose of study drug as a safety check.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 1 diabetes mellitus for at least 24 months

Exclusion Criteria:

• Pregnant or Lactating
• HbA1c >10.5% at screening
• Use of > 2.0 U/kg total insulin dose per day
• Inadequate bilateral venous access in both arms
• Renal insufficiency
• Congestive heart failure, NYHA class II, III or IV
• Active malignancy within 5 years from screening
• Major surgical operation within 30 days prior to screening
• Seizure or bleeding disorder
• Glycogen storage disease
• Active substance or alchohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucagon; 1 mg G-Pen™ (glucagon injection) first, followed by 0.5 mg	Drug: Glucagon; Other Names: G-Pen™ (glucagon injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment	For 90 minutes following treatment, plasma glucose was measured every 5 minutes, with an increase in plasma glucose to >70 mg/dL within 30 minutes of treatment being considered a positive response.	0-90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Plasma Glucose > 70 mg/dL	Following treatment, plasma glucose was measured every 5 minutes. The first such measurement at which plasma glucose concentration was observed to be >70 mg/dL was reported as the time to response.	0-90 minutes
Time to Resolution of Induced Hypoglycemia Symptoms	Prior to and every 5 minutes after treatment, subjects were asked to rate the severity of each of 8 symptoms on a scale from 1 to 6, with 1 indicating the symptom was absent and 6 indicating the symptom was severe. The sum of the scores for the 8 individual symptoms was reported as the total hypoglycemia symptom score, which ranged from 8-48. The first time point post-treatment at which total hypoglycemia symptom score = 8 (i.e., all symptoms were absent) was considered the time to resolution. One and two subjects were unevaluable for response to the 1 mg and 0.5 mg doses of glucagon, respectively, as they reported no symptoms (i.e., total symptom score = 8) prior to treatment.	0-30 minutes

Collaborators and Investigators

• Sponsor: Xeris Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimate): April 22, 2015

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Glucagon; Glucagon-Like Peptide 1
• Other Study ID Numbers: XSGP-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO