G-Pen™ for Hypoglycemia Rescue in T1D Patients

Xeris Pharmaceuticals7 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypoglycemia

Interventions

GlucagonDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 0-90 minutes

Secondary Outcomes

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.

Time frame: 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.

Time frame: 0-30 minutes

Data from ClinicalTrials.gov

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