Trial · Interventional

CompletedPhase 2Results postedRegistry data

G-Pen™ for Hypoglycemia Rescue in T1D Patients

NCTNCT02423980Other idXSGP-202

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 7 participants (actual)
Sponsor: Xeris Pharmaceuticals · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Apr 2015
Primary completion: May 2015
Completion: Jun 2015
First posted: 22 Apr 2015 (estimated)
Last update posted: 7 Jul 2017
Conditions: Hypoglycemia

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20152016

Ph 2
G-Pen™ for Hypoglycemia Rescue in T1D Patients
NCT02423980
Apr 2015 to Jun 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

GlucagonDrug

Arms1

Experimental
Glucagon
1 mg G-Pen™ (glucagon injection) first, followed by 0.5 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment
Time frame · 0-90 minutes
Registry description
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.

Secondary outcomes(2)

Time to Plasma Glucose > 70 mg/dL
Time frame · 0-90 minutes
Registry description
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 to Resolution of Induced Hypoglycemia Symptoms
Time frame · 0-30 minutes
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 0-90 minutes

Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment

Group	Value (participants with positive response)
Glucagon 1 mg	7
Glucagon 0.5 mg	6

Secondary and other outcome results(2)

Secondary outcomeMedian· 0-90 minutes

Time to Plasma Glucose > 70 mg/dL

Group	Value (minutes)
Glucagon 1 mg	15
Glucagon 0.5 mg	15

Secondary outcomeMedian· 0-30 minutes

Time to Resolution of Induced Hypoglycemia Symptoms

Group	Value (minutes)
Glucagon 1 mg	20
Glucagon 0.5 mg	27.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Glucagon 1 mg1 mg G-Pen™ (glucagon injection) Glucagon	–	1 / 7	3 / 7
Glucagon 0.5 mg0.5 mg G-Pen™ (glucagon injection) Glucagon	–	0 / 6	2 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

PepBank is a research reference. Talk to a doctor before you use any peptide.