Diabetes Mellitus, Type 1Phase 3NCT03091673
Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients
A Phase 3 study testing Glucagon in people with Diabetes Mellitus, Type 1, run by Xeris Pharmaceuticals at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Mar 2017to 27 Sep 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed with T1D for at least 6 months at Screening.
- current usage of daily insulin treatment.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Women & Children's Hospital of Buffalo
Buffalo, New York, 14222
University of Florida
Gainesville, Florida, 32611
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52422
Yale University
New Haven, Connecticut, 06511
Stanford University
Stanford, California, 94305
About this study
Official title: A Phase 3 Study to Evaluate the Glucose Response of G-Pen (Glucagon Injection) in Pediatric Patients With Type 1 Diabetes
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.
Read the detailed description
This is an open-label, Phase 3 sequential efficacy and safety study in pediatric patients ages 2-17 with type 1 diabetes. Patients will complete the screening procedures up to 30 days before dosing to determine eligibility before enrollment to the treatment phase.
The procedure to evaluate the efficacy of G-Pen (glucagon injection) consists of inducing a low normal glycemic state by administration of insulin. Subjects ages 2-11 will then be given a 0.5 mg dose of G-Pen, while subjects ages 12-17 will receive a 1 mg dose of G-Pen. Subjects ages 12-17 will return for a second visit 1-4 weeks later and will receive a 0.5 mg dose of G-Pen when in a low normal glycemic stare. Plasma glucose and glucagon levels will be monitored for 90 and 180 minutes post-dosing, respectively, at all visits.
A follow-up phone call as a safety check will be conducted 3 - 14 days following administration of the final dose.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Glucagon
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonDrug
Also called G-Pen (glucagon injection)
0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
| Study group | Role | What they receive |
|---|---|---|
| G-Pen (glucagon injection) 0.5 mg | Experimental | A single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection) Receives: Drug: Glucagon |
| G-Pen (glucagon injection) 1.0 mg | Experimental | A single 1.0 mg subcutaneous (SC) injection of G-Pen (glucagon injection) Receives: Drug: Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Glucose
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.
Measured: 0-30 minutes
Secondary outcomes (4)
Time for Plasma Glucose to Increase by ≥25 mg/dL
Time for plasma glucose to increase by ≥25 mg/dL from baseline will be analyzed descriptively for each age cohort.
Measured: 0-90 minutes
Plasma Glucagon Area Under the Curve
Plasma glucagon area under the curve (AUC) for each age cohort will be analyzed descriptively.
Measured: 0-90 minutes
Plasma Glucagon Cmax
Plasma glucagon maximum concentration for each age cohort will be analyzed descriptively.
Measured: 0-180 minutes
Plasma Glucagon Tmax
Plasma glucagon time to maximum concentration for each age cohort will be analyzed descriptively.
Measured: 0-180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start27 Mar 2017
- Primary completion7 Sep 2017
- Study completion27 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeris Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Emmes Company, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091673
- Sponsor's protocol ID
- XSGP-302
- Status last verified
- Nov 2018
- First submitted
- 16 Mar 2017
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study to Evaluate the Glucose Response of G-Pen (Glucagon Injection) in Pediatric Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03091673
- Acronym / sponsor ID
- XSGP-302
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Xeris PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- The Emmes Company, LLC
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Posted 16 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, Phase 3 sequential efficacy and safety study in pediatric patients ages 2-17 with type 1 diabetes. Patients will complete the screening procedures up to 30 days before dosing to determine eligibility before enrollment to the treatment phase.
The procedure to evaluate the efficacy of G-Pen (glucagon injection) consists of inducing a low normal glycemic state by administration of insulin. Subjects ages 2-11 will then be given a 0.5 mg dose of G-Pen, while subjects ages 12-17 will receive a 1 mg dose of G-Pen. Subjects ages 12-17 will return for a second visit 1-4 weeks later and will receive a 0.5 mg dose of G-Pen when in a low normal glycemic stare. Plasma glucose and glucagon levels will be monitored for 90 and 180 minutes post-dosing, respectively, at all visits.
A follow-up phone call as a safety check will be conducted 3 - 14 days following administration of the final dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-Pen (glucagon injection) 0.5 mg | Experimental | Drug: GlucagonA single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection) |
| G-Pen (glucagon injection) 1.0 mg | Experimental | Drug: GlucagonA single 1.0 mg subcutaneous (SC) injection of G-Pen (glucagon injection) |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosed with T1D for at least 6 months at Screening.
- current usage of daily insulin treatment.
Key exclusion criteria (14 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucagonAlso: G-Pen (glucagon injection)0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector | Drug | G-Pen (glucagon injection) 0.5 mg, G-Pen (glucagon injection) 1.0 mg |
Primary outcome
Change in Plasma Glucose
Time frame: 0-30 minutes
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.
4 secondary outcomes
Time for Plasma Glucose to Increase by ≥25 mg/dL
Time frame: 0-90 minutes
Plasma Glucagon Area Under the Curve
Time frame: 0-90 minutes
Plasma Glucagon Cmax
Time frame: 0-180 minutes
Plasma Glucagon Tmax
Time frame: 0-180 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glucagon in people with Diabetes Mellitus, Type 1, run by Xeris Pharmaceuticals at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Glucose (time frame: 0-30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.