G-Pen™ for Hypoglycemia Rescue in T1D Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypoglycemia

Intervention / Treatment
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* Drug: Glucagon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucagon<br>1 mg G-Pen™ (glucagon injection) first, followed by 0.5 mg | Drug: Glucagon<br> <br> * Other names: G-Pen™ (glucagon injection);|

What is the study measuring?
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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 |