Primary outcomeMean· 0-30 minutes
Change in Plasma Glucose
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Subjects 2 to <6 Years of Age | 81.4 | 18.3 |
| Subjects 6 to <12 Years of Age | 84.2 | 25.3 |
| Subjects 12 to <18 Years of Age | 54.0 | 27.3 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataGlucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients
NCTNCT03091673 (opens ClinicalTrials.gov in a new tab)Other idXSGP-302
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 31 participants (actual)
- Sponsor
- Xeris Pharmaceuticals · Industry
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 27 Mar 2017
- Primary completion
- 7 Sept 2017
- Completion
- 27 Sept 2017
- First posted
- 27 Mar 2017
- Last update posted
- 11 Dec 2018
- Conditions
- Diabetes Mellitus, Type 1
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20172018
- Ph 3
Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients
NCT0309167327 Mar 2017 to 27 Sept 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes. Subjects will be administered insulin to induce a low normal glycemic state and will then receive an age-appropriate dose of G-Pen (glucagon injection) in a clinical research center (CRC) or comparable setting.
Interventions
- GlucagonDrug
Arms2
Experimental
G-Pen (glucagon injection) 0.5 mg
A single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection)
Experimental
G-Pen (glucagon injection) 1.0 mg
A single 1.0 mg subcutaneous (SC) injection of G-Pen (glucagon injection)
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Plasma Glucose
Time frame · 0-30 minutes
Registry description
The primary endpoint for this study is an evaluation of change in plasma glucose following treatment with G-Pen, with an emphasis on the increase from baseline to 30 minutes post-dosing.
Secondary outcomes(4)
Time for Plasma Glucose to Increase by ≥25 mg/dL
Time frame · 0-90 minutes
Registry description
Time for plasma glucose to increase by ≥25 mg/dL from baseline will be analyzed descriptively for each age cohort.
Plasma Glucagon Area Under the Curve
Time frame · 0-90 minutes
Registry description
Plasma glucagon area under the curve (AUC) for each age cohort will be analyzed descriptively.
Plasma Glucagon Cmax
Time frame · 0-180 minutes
Registry description
Plasma glucagon maximum concentration for each age cohort will be analyzed descriptively.
Plasma Glucagon Tmax
Time frame · 0-180 minutes
Registry description
Plasma glucagon time to maximum concentration for each age cohort will be analyzed descriptively.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(4)
Secondary outcomeMean· 0-90 minutes
Time for Plasma Glucose to Increase by ≥25 mg/dL
| Group | Value (minutes) | Spread |
|---|---|---|
| Subjects 2 to <6 Years of Age | 16.4 | 3.78 |
| Subjects 6 to <12 Years of Age | 16.2 | 4.63 |
| Subjects 12 to <18 Years of Age | 26.6 | 9.51 |
Secondary outcomeMean· 0-90 minutes
Plasma Glucagon Area Under the Curve
| Group | Value (min*mg/dL) | Spread |
|---|---|---|
| Subjects 2 to <6 Years of Age | 14440.8 | 2114.9 |
| Subjects 6 to <12 Years of Age | 14392.3 | 2698.4 |
| Subjects 12 to <18 Years of Age | 13105.5 | 13105.45 |
Secondary outcomeMean· 0-180 minutes
Plasma Glucagon Cmax
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Subjects 2 to <6 Years of Age | 202.3 | 35.9 |
| Subjects 6 to <12 Years of Age | 216.3 | 51.2 |
| Subjects 12 to <18 Years of Age | 199.0 | 57.0 |
Secondary outcomeMean· 0-180 minutes
Plasma Glucagon Tmax
| Group | Value (minutes) | Spread |
|---|---|---|
| Subjects 2 to <6 Years of Age | 66.6 | 10.5 |
| Subjects 6 to <12 Years of Age | 68.5 | 15.3 |
| Subjects 12 to <18 Years of Age | 81.2 | 14.9 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Subjects 2 to <6 Years of AgeStudy subjects at least 2, but less than 6 years of age at the time of receiving a 0.5 mg dose of G-Pen. | 0 / 7 | 0 / 7 | 5 / 7 |
| Subjects 6 to <12 Years of AgeStudy subjects at least 6, but less than 12 years of age at the time of receiving a 0.5 mg dose of G-Pen. | 0 / 13 | 0 / 13 | 12 / 13 |
| Subjects 12 to <18 Years of AgeStudy subjects at least 12, but less than 18 years of age at the time of receiving a 1 mg dose of G-Pen. | 0 / 11 | 0 / 11 | 8 / 11 |
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
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 2 Years up to 17 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* diagnosed with T1D for at least 6 months at Screening.
* current usage of daily insulin treatment.
Exclusion Criteria:
* pregnant or nursing
* 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 venous access
* current seizure disorder
* history of pheochromocytoma or disorder with increased risk of pheochromocytoma
* history of insulinoma
* history of glycogen storage disease.
* active use of alcohol or drugs of abuse
* administration of glucagon within 14 days of the first treatment visit
* participation in other studies involving an investigational drug or device within 30 days
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