Serious Adverse Events
| Group | Value (participants) |
|---|---|
| G-Pen Mini™ (Glucagon Injection) 75 ug | 0 |
| G-Pen Mini™ (Glucagon Injection) 150 ug | 0 |
| G-Pen Mini™ (Glucagon Injection) 300 ug | 0 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes
NCT02081014Mar 2014 to Nov 2014
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to moderate hypoglycemia, a complication of diabetes.
Experimental
G-Pen Mini™ (glucagon injection) 75 ug
G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
Experimental
G-Pen Mini™ (glucagon injection) 150 ug
G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
Experimental
G-Pen Mini™ (glucagon injection) 300 ug
G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
Outcomes the sponsor listed as primary.
Serious Adverse Events
Time frame · From first dose until follow-up call, up to 7 weeks per subject
Number of serious adverse events (SAEs) per treatment
Glucagon Cmax (Fasting)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Pharmacokinetic parameter: Maximum concentration of glucagon
Glucagon Cmax (Post-insulin)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Pharmacokinetic parameter: Maximum concentration of glucagon
Glucagon Area Under the Curve (AUC) (Fasting)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes
Glucagon AUC (Post-insulin)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes
Glucagon Tmax (Fasting)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Pharmacokinetic parameter: Time to reach maximum concentration of glucagon
Glucagon Tmax (Post-insulin)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Pharmacokinetic parameter: Time to reach maximum concentration of glucagon
Glucose Cmax (Fasting)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Pharmacodynamic parameter: Maximum concentration of glucose
Glucose Cmax (Post-insulin)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Pharmacodynamic parameter: Maximum concentration of glucose
Glucose AUC (Fasting)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes
Glucose AUC (Post-insulin)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes
Glucose Tmax (Fasting)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Pharmacodynamic parameter: Time to reach maximum concentration of glucose
Glucose Tmax (Post-insulin)
Time frame · Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Pharmacodynamic parameter: Time to reach maximum concentration of glucose
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (participants) |
|---|---|
| G-Pen Mini™ (Glucagon Injection) 75 ug | 0 |
| G-Pen Mini™ (Glucagon Injection) 150 ug | 0 |
| G-Pen Mini™ (Glucagon Injection) 300 ug | 0 |
| Group | Value (pg/ml) | Spread |
|---|---|---|
| G-Pen Mini™ (Glucagon Injection) 75 ug | 233.8 | 34 |
| G-Pen Mini™ (Glucagon Injection) 150 ug | 380.7 | 34 |
| G-Pen Mini™ (Glucagon Injection) 300 ug | 663.6 | 34 |
| Group | Value (pg/ml) | Spread |
|---|---|---|
| G-Pen Mini™ (Glucagon Injection) 75 ug | 253.4 | 30.1 |
| G-Pen Mini™ (Glucagon Injection) 150 ug | 335.4 | 30.1 |
| G-Pen Mini™ (Glucagon Injection) 300 ug | 561.7 | 29.9 |
| Group | Value ((pg/ml)*hour) | Spread |
|---|---|---|
| G-Pen Mini™ (Glucagon Injection) 75 ug | 265.4 | 35.4 |
| G-Pen Mini™ (Glucagon Injection) 150 ug | 389.6 | 35.4 |
| G-Pen Mini™ (Glucagon Injection) 300 ug | 735.3 | 35.4 |
| Group | Value ((pg/ml)*hour) | Spread |
|---|---|---|
| G-Pen Mini™ (Glucagon Injection) 75 ug | 277.4 | 29.9 |
| G-Pen Mini™ (Glucagon Injection) 150 ug | 386.8 | 29.9 |
| G-Pen Mini™ (Glucagon Injection) 300 ug | 635.3 | 29.7 |
| Group | Value (minutes) | Spread |
|---|---|---|
| G-Pen Mini™ (Glucagon Injection) 75 ug | 29.2 | 3.6 |
| G-Pen Mini™ (Glucagon Injection) 150 ug | 29.8 | 3.6 |
| G-Pen Mini™ (Glucagon Injection) 300 ug | 36.5 | 3.6 |
| Group | Value (minutes) | Spread |
|---|---|---|
| G-Pen Mini™ (Glucagon Injection) 75 ug | 24 | 2.7 |
| G-Pen Mini™ (Glucagon Injection) 150 ug | 33.1 | 2.7 |
| G-Pen Mini™ (Glucagon Injection) 300 ug | 34.1 | 2.7 |
| Group | Value (mg/dl) | Spread |
|---|---|---|
| G-Pen Mini™ (Glucagon Injection) 75 ug | 155.1 | 11.2 |
| G-Pen Mini™ (Glucagon Injection) 150 ug | 186.2 | 11.1 |
| G-Pen Mini™ (Glucagon Injection) 300 ug | 213.5 | 11.2 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| G-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart | – | 0 / 12 | 10 / 12 |
| G-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart | – | 0 / 12 | 11 / 12 |
| G-Pen Mini™ (Glucagon Injection) 300 ugG-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart | – | 0 / 12 | 11 / 12 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
PubMed tag: none · 2016
Haymond et al. 2016Diabetes carecited by 34
PMID 26861921PMC4764034DOI 10.2337/dc15-2124PUB-26861921
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated