Phase 2
Completed N=7
G-Pen™ for Hypoglycemia Rescue in T1D Patients
Source: ClinicalTrials.gov NCT02423980 ↗Enrolled (actual)
7
Serious AEs
7.7%
Results posted
Apr 2017
Primary outcomePrimary: Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment — 7; 6 participants with positive response
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment |
7; 6 | — |
| SECONDARY Time to Plasma Glucose > 70 mg/dL |
15; 15 | — |
| SECONDARY Time to Resolution of Induced Hypoglycemia Symptoms |
20; 27.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02423980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.