Tmax
| Group | Value (minutes) | Spread |
|---|---|---|
| Xeris Glucagon | 23.8 | 9.3 |
| Lilly Glucagon | 15.7 | 3.0 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon
NCT02018627Apr 2014 to 2 Aug 2018
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of Glucagon for Injection (Eli Lilly).
Experimental
Xeris glucagon
Xeris glucagon 50 micrograms, subcutaneous injection
Active comparator
Lilly glucagon
Lilly glucagon 30 micrograms, subcutaneous injection
Outcomes the sponsor listed as primary.
Tmax
Time frame · every 2 minutes for 1 hour post-dose of each glucagon
tmax for Xeris vs. Lilly (non-inferiority)
AOCGIR
Time frame · every 2 minutes for 1 hour post-dose of each glucagon
Area over the curve for glucose infusion rate in the hour following administration (AOCGIR) for Xeris vs. Lilly (non-inferiority)
GIRmin
Time frame · every 2 minutes for 1 hour post-dose of each glucagon
Minimal glucose infusion rate (GIRmin) for Xeris vs. Lilly (non-inferiority)
t½Max
Time frame · every 2 minutes for 1 hour post-dose of each glucagon
Glucagon t½max for Xeris vs. Lilly (non-inferiority)
Injection Pain
Time frame · immediately after injection
Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -average Injection pain on a 10 cm standard VAS: 0 = no pain, 10 = worst imaginable pain reported immediately after injection of glucagon
Injection Site Erythema
Time frame · within 1 hour of injection
Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -Injection site erythema or other local reaction, maximum diameter within 1 hour of injection
Maximal Nausea
Time frame · within 1 hour of injection
Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly: -Maximal nausea within 1 hour of injection on a 10 cm VAS: no nausea = 0, vomiting = 10
Dermal Response (Draize Scale for Erythema and Eschar Formation)
Time frame · within 1 hour of injection
Average grade on the erythema and eschar formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest)
Dermal Response (Draize Scale Grade for Edema Formation)
Time frame · within 1 hour of injection
Average grade on the edema formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest)
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (minutes) | Spread |
|---|---|---|
| Xeris Glucagon | 23.8 | 9.3 |
| Lilly Glucagon | 15.7 | 3.0 |
| Group | Value (mg*min/kg) | Spread |
|---|---|---|
| Xeris Glucagon | 201.1 | 275.5 |
| Lilly Glucagon | 132.2 | 87.9 |
| Group | Value (dextrose mg/kg/min) | Spread |
|---|---|---|
| Xeris Glucagon | 2.9 | 2.2 |
| Lilly Glucagon | 2.9 | 1.8 |
| Group | Value (minutes) | Spread |
|---|---|---|
| Xeris Glucagon | 11.3 | 3.1 |
| Lilly Glucagon | 5.9 | 2.1 |
| Group | Value (cm) | Spread |
|---|---|---|
| Xeris Glucagon | 13.8 | 17.7 |
| Lilly Glucagon | 7.6 | 8.7 |
| Group | Value (cm) | Spread |
|---|---|---|
| Xeris Glucagon | 0 | 0 |
| Lilly Glucagon | 0 | 0 |
| Group | Value (cm) |
|---|---|
| Xeris Glucagon | 1.0 |
| Lilly Glucagon | 2.3 |
| Group | Value (score on draize scale) | Spread |
|---|---|---|
| Xeris Glucagon | 0 | 0 |
| Lilly Glucagon | 0 | 0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Xeris GlucagonXeris glucagon 50 micrograms, subcutaneous injection Xeris glucagon: The subject is given an injection of xeris glucagon | 0 / 13 | 0 / 13 | 0 / 13 |
| Lilly GlucagonLilly glucagon 30 micrograms, subcutaneous injection Lilly glucagon: The subject is given an injection of lilly glucagon | 0 / 13 | 0 / 13 | 0 / 13 |
Each cell reads participants affected / participants at risk, as the registry posted them.
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