Phase 3
Completed N=80
Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics
Hypoglycemia · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02656069 ↗
Enrolled (actual)
80
Serious AEs
0.6%
Results posted
Sep 2018
Primary outcomePrimary: Hypoglycemia Rescue: Intent-to-Treat Population — 74; 79 Participants
◆ Published Evidence
Established
22citations · ~4 / year
Comparison of a ready-to-use liquid glucagon injection administered by autoinjector to glucagon emergency kit for the symptomatic relief of severe hypoglycemia: two randomized crossover non-inferiority studies.
Summary
This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for hypoglycemia rescue of adult patients with type 1 diabetes.
Linked Publications
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Comparison of a ready-to-use liquid glucagon injection administered by autoinjector to glucagon emergency kit for the symptomatic relief of severe hypoglycemia: two randomized crossover non-inferiority studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypoglycemia Rescue: Intent-to-Treat Population |
74; 79 | — |
| PRIMARY Hypoglycemia Rescue: Per Protocol Population |
74; 78 | — |
| PRIMARY Hypoglycemia Rescue: Alternate Glucose Response Definition |
76; 79 | — |
| SECONDARY Plasma Glucose Area Under the Curve (AUC) |
11651.4; 12260.4 | — |
| SECONDARY Plasma Glucose Maximum Concentration (Cmax) |
202.7; 193.5 | — |
| SECONDARY Plasma Glucose Time to Maximum Concentration (Tmax) |
111.3; 100.4 | — |
| SECONDARY Plasma Glucose Time to Concentration > 70 mg/dL |
19.9; 14.2 | — |
| SECONDARY Time to Resolution of Hypoglycemia Symptoms |
16.0; 14.2; 16.7; 14.3; 19.8; 17.0 | — |
| SECONDARY Global Assessment of Hypoglycemia |
16.8; 15.7 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosed with type 1 diabetes mellitus for at least 24 months
- usage of daily insulin treatment
- random serum C-peptide concentration 9.0%
- renal insufficiency
- hepatic synthetic insufficiency
- aspartate or alanine aminotransferase > 3 times the upper limit of normal
- hematocrit less than or equal to 30%
- use of > 2.0 U/kg total insulin dose per day
- inadequate bilateral venous access in both arms
- congestive heart failure, New York Heart Association class II, III or IV
- active malignancy within 5 years, except basal cell or squamous cell skin cancers
- history of breast cancer or malignant melanoma
- major surgical operation within 30 days
- current seizure disorder.
- current bleeding disorder, treatment with warfarin, or platelet count below 50,000
- history of pheochromocytoma or disorder with increased risk of pheochromocytoma
- history of insulinoma
- history of glycogen storage disease.
- positive for HIV, hepatitis C virus or active hepatitis B virus infection
- whole blood donation of 1 pint (500 mL) within 8 weeks
- active substance or alcohol abuse
- administration of glucagon within 28 days
- participation in other studies involving an investigational drug or device within 30 days
Data sourced from ClinicalTrials.gov (NCT02656069) and the linked publication. 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.