Serious Adverse Events
| Group | Value (events) |
|---|---|
| G-Pen(TM) 1 mg | 0 |
| G-Pen(TM) 0.5 mg | 0 |
| Lilly Glucagon(TM) 1 mg | 0 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia
NCT01972152Oct 2013 to Feb 2014
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.
Experimental
G-Pen(TM) 1 mg
G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection
Experimental
G-Pen(TM) 0.5 mg
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
Active comparator
Lilly Glucagon(TM) 1 mg
Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
Outcomes the sponsor listed as primary.
Serious Adverse Events
Time frame · From first dose until completion of the post-treatment follow-up visit, up to 6 weeks
Number of serious adverse events (SAEs) per treatment group
Glucose Area Under the Curve (AUC)
Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Pharmacodynamic parameter: Glucose area under the curve from baseline to 240 minutes post-treatment
Glucose Cmax
Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Pharmacodynamic parameter: Maximum concentration of glucose
Glucose Tmax
Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Pharmacodynamic parameter: Time to Maximum Glucose Concentration
Glucose AUCex
Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Pharmacodynamic parameter: Area Under the Glucose Excursion Curve
Glucose MAE
Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Pharmacodynamic parameter: Maximum absolute glucose excursion from baseline
Glucose Tex
Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Pharmacodynamic parameter: Earliest reported time of MAE, based on within-subject changes from baseline
Glucagon AUC
Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Pharmacokinetic parameter: Glucagon area under the curve from baseline to 240 minutes post-treatment
Glucagon Cmax
Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Pharmacokinetic parameter: Maximum concentration of glucagon
Glucagon Tmax
Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection
Pharmacokinetic parameter: Time to maximum concentration of glucagon
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (events) |
|---|---|
| G-Pen(TM) 1 mg | 0 |
| G-Pen(TM) 0.5 mg | 0 |
| Lilly Glucagon(TM) 1 mg | 0 |
| Group | Value (min*mg/dL) | Spread |
|---|---|---|
| G-Pen(TM) 1 mg | 481.1 | 64.9 |
| G-Pen(TM) 0.5 mg | 467 | 47.9 |
| Lilly Glucagon(TM) 1 mg | 473.5 | 72.9 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| G-Pen(TM) 1 mg | 148.04 | 24.94 |
| G-Pen(TM) 0.5 mg | 140.32 | 23.59 |
| Lilly Glucagon(TM) 1 mg | 154.9 | 28.02 |
| Group | Value (minutes) | Spread |
|---|---|---|
| G-Pen(TM) 1 mg | 48.2 | 11.8 |
| G-Pen(TM) 0.5 mg | 44.5 | 11.2 |
| Lilly Glucagon(TM) 1 mg | 46.5 | 20.5 |
| Group | Value (min*mg/dL) | Spread |
|---|---|---|
| G-Pen(TM) 1 mg | 228.5 | 89.1 |
| G-Pen(TM) 0.5 mg | 197.3 | 74.7 |
| Lilly Glucagon(TM) 1 mg | 223 | 101.5 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| G-Pen(TM) 1 mg | 50.8 | 22 |
| G-Pen(TM) 0.5 mg | 42.5 | 19.8 |
| Lilly Glucagon(TM) 1 mg | 53.2 | 18.8 |
| Group | Value (minutes) | Spread |
|---|---|---|
| G-Pen(TM) 1 mg | 48.2 | 11.8 |
| G-Pen(TM) 0.5 mg | 61.6 | 52.3 |
| Lilly Glucagon(TM) 1 mg | 68.8 | 44.4 |
| Group | Value (min*pg/ml) | Spread |
|---|---|---|
| G-Pen(TM) 1 mg | 3259.9 | 3447.5 |
| G-Pen(TM) 0.5 mg | 2105.3 | 2381.9 |
| Lilly Glucagon(TM) 1 mg | 4781.7 | 2222.9 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| G-Pen(TM) 1 mgG-Pen(TM) (glucagon injection), single 1 mg SC injection G-Pen(TM) 1 mg Lilly Glucagon(TM) 1 mg G-Pen(TM) 0.5 mg | – | 0 / 28 | 22 / 28 |
| G-Pen(TM) 0.5 mgG-Pen(TM) (glucagon injection), single 0.5 mg SC injection G-Pen(TM) 1 mg Lilly Glucagon(TM) 1 mg G-Pen(TM) 0.5 mg | – | 0 / 29 | 26 / 29 |
| Lilly Glucagon(TM) 1 mgLilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection G-Pen(TM) 1 mg Lilly Glucagon(TM) 1 mg G-Pen(TM) 0.5 mg | – | 0 / 28 | 22 / 28 |
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