G-Pen™ for Hypoglycemia Rescue in T1D Patients

Phase 2

Completed

• Conditions: Hypoglycemia
• Interventions: Drug: Glucagon

• Registration Number: NCT02423980
• Lead Sponsor: Xeris Pharmaceuticals

Brief Summary

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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Results First Submitted: 2017-02-12
• Results First Submitted QC: 2017-03-13
• Results First Posted: 2017-04-24
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment	0-90 minutes	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 Outcome Measures

Name	Time	Method
Time to Plasma Glucose > 70 mg/dL	0-90 minutes	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	0-30 minutes	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.

Trial Locations

Locations (1)

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States