Type 1 DiabetesPhase 2/3NCT02018627
Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon
A Phase 2/3 study testing Xeris glucagon and Lilly glucagon in people with Type 1 Diabetes, run by Steven J. Russell, MD, PhD at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Xeris glucagon and Lilly glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 2 Aug 2018
- Phase
- Phase 2/3
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 to 80 years old with type 1 diabetes for at least one year.
- Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least one week prior to enrollment.
Who cannot join
- Unable to provide informed consent.
- Unable to comply with study procedures.
- Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject.
- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
- Hemoglobin < 11.5 gm/dl.
Show all 11Show fewer
- History of pheochromocytoma. Fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor (paroxysms of tachycardia, pallor, or headache; personal or family history of MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease; episodic or treatment of refractory hypertension, defined as requiring 4 or more medications to achieve normotension).
- History of adverse reaction to glucagon (including allergy) besides nausea, vomiting, or headache.
- Inadequate venous access as determined by study nurse or physician at time of screening.
- Liver failure or cirrhosis.
- Any other factors that, in the judgment of the principal investigator, would interfere with the safe completion of the study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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).
Read the detailed description
This study will test the hypothesis that micro-doses of a new formulation of stable glucagon, Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon that has poor stability in solution, Glucagon for Injection (Eli Lilly).
- Conditions
- Type 1 Diabetes
- Being tested
- Xeris glucagon, Lilly glucagon
- Keywords
- bionic pancreas, artificial pancreas, insulin, glucagon, clamp
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeris glucagonDrug
The subject is given an injection of xeris glucagon
Lilly glucagonDrug
The subject is given an injection of lilly glucagon
| Study group | Role | What they receive |
|---|---|---|
| Xeris glucagon | Experimental | Xeris glucagon 50 micrograms, subcutaneous injection Receives: Drug: Xeris glucagon |
| Lilly glucagon | Active comparator | Lilly glucagon 30 micrograms, subcutaneous injection Receives: Drug: Lilly glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax
tmax for Xeris vs. Lilly (non-inferiority)
Measured: every 2 minutes for 1 hour post-dose of each glucagon
Secondary outcomes (8)
AOCGIR
Area over the curve for glucose infusion rate in the hour following administration (AOCGIR) for Xeris vs. Lilly (non-inferiority)
Measured: every 2 minutes for 1 hour post-dose of each glucagon
GIRmin
Minimal glucose infusion rate (GIRmin) for Xeris vs. Lilly (non-inferiority)
Measured: every 2 minutes for 1 hour post-dose of each glucagon
t½Max
Glucagon t½max for Xeris vs. Lilly (non-inferiority)
Measured: every 2 minutes for 1 hour post-dose of each glucagon
Injection Pain
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
Measured: immediately after injection
Injection Site Erythema
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
Measured: within 1 hour of injection
Maximal Nausea
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
Measured: within 1 hour of injection
Dermal Response (Draize Scale for Erythema and Eschar Formation)
Average grade on the erythema and eschar formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest)
Measured: within 1 hour of injection
Dermal Response (Draize Scale Grade for Edema Formation)
Average grade on the edema formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest)
Measured: within 1 hour of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startApr 2014
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
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 Type 1 DiabetesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven J. Russell, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven J. Russell, MD, PhD, Massachusetts General Hospital
- Investigators
- Steven J Russell, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018627
- Sponsor's protocol ID
- 2013P002549
- Status last verified
- Sep 2019
- First submitted
- 16 Dec 2013
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon
- ClinicalTrials.gov ID
- NCT02018627
- Acronym / sponsor ID
- 2013P002549
- Conditions
- Type 1 Diabetes
- Keywords
- bionic pancreas, artificial pancreas, insulin, glucagon, clamp
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Steven J. Russell, MD, PhDUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Posted 8 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study will test the hypothesis that micro-doses of a new formulation of stable glucagon, Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon that has poor stability in solution, Glucagon for Injection (Eli Lilly).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xeris glucagon | Experimental | Drug: Xeris glucagonXeris glucagon 50 micrograms, subcutaneous injection |
| Lilly glucagon | Active comparator | Drug: Lilly glucagonLilly glucagon 30 micrograms, subcutaneous injection |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 21 to 80 years old with type 1 diabetes for at least one year.
- Diabetes managed using an insulin infusion pump using rapid-acting insulin such as insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least one week prior to enrollment.
Key exclusion criteria (11 listed)
- Unable to provide informed consent.
- Unable to comply with study procedures.
- Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject.
- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception.
- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
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 |
|---|---|---|
| Xeris glucagonThe subject is given an injection of xeris glucagon | Drug | Xeris glucagon |
| Lilly glucagonThe subject is given an injection of lilly glucagon | Drug | Lilly glucagon |
Primary outcome
Tmax
Time frame: every 2 minutes for 1 hour post-dose of each glucagon
tmax for Xeris vs. Lilly (non-inferiority)
8 secondary outcomes
AOCGIR
Time frame: every 2 minutes for 1 hour post-dose of each glucagon
GIRmin
Time frame: every 2 minutes for 1 hour post-dose of each glucagon
t½Max
Time frame: every 2 minutes for 1 hour post-dose of each glucagon
Injection Pain
Time frame: immediately after injection
Injection Site Erythema
Time frame: within 1 hour of injection
Maximal Nausea
Time frame: within 1 hour of injection
Dermal Response (Draize Scale for Erythema and Eschar Formation)
Time frame: within 1 hour of injection
Dermal Response (Draize Scale Grade for Edema Formation)
Time frame: within 1 hour of injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steven J Russell, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Xeris glucagon and Lilly glucagon in people with Type 1 Diabetes, run by Steven J. Russell, MD, PhD at 1 site 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 11 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 Oct 2019). 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?
Tmax (time frame: every 2 minutes for 1 hour post-dose of each glucagon). 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 8 Oct 2019.