HypoglycemiaPhase 2NCT02081001

PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients

A Phase 2 study testing Novo Nordisk GlucaGen® and G-Pump™ (glucagon infusion) in people with Hypoglycemia, run by Xeris Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to patients with type 1 diabetes. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hypoglycemia
What is being tested?: Novo Nordisk GlucaGen® and G-Pump™ (glucagon infusion)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: Mar 2014to Sep 2014
Phase: Phase 2
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females diagnosed with type 1 diabetes mellitus for at least 24 months
Current usage of subcutaneous insulin pump treatment
Age 18-65 years
C-peptide level < 0.5 ng/ml
Willingness to follow all study procedures, including attending all clinic visits
Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities

Who cannot join

Pregnant and/ or Lactating: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study.
HbA1c >10.0%
Renal insufficiency (serum creatinine of 1.2 mg/dL or greater)
Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL; or serum bilirubin of over 2.0.
Hematocrit of less than or equal to 34%
Congestive heart failure, NYHA class II, III or IV

Show all 25Show fewer

History of coronary artery disease
Active foot ulceration
History of a cerebrovascular accident
Active alcohol abuse or substance abuse
Active malignancy, except basal cell or squamous cell skin cancers
Major surgical operation within 30 days prior to screening
Seizure disorder
Current administration of oral or parenteral corticosteroids
Use of an investigational drug within 30 days prior to screening
Bleeding disorder, treatment with warfarin, or platelet count below 50,000
Proliferative or severe non-proliferative retinopathy
Gastroparesis
Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease)
Insulinoma
Allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products.
Glycogen storage disease
Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen
Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening.
Any reason the principal investigator deems exclusionary

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Comparison of Pharmacokinetic and Pharmacodynamic Profiles of G-Pump™ (Glucagon Infusion) vs. GlucaGen® Delivered Subcutaneously to Subjects With Type 1 Diabetes (T1DM)

Conditions: Hypoglycemia
Being tested: Novo Nordisk GlucaGen®, G-Pump™ (glucagon infusion)
Keywords: Hypoglycemia, Glucagon, Artificial Pancreas
Medical subject headings: Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Novo Nordisk GlucaGen®Drug
single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
G-Pump™ (glucagon infusion)Drug
single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Study groups in NCT02081001
Study group	Role	What they receive
G-Pump™ (glucagon infusion)	Experimental	G-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg Receives: Drug: Novo Nordisk GlucaGen®; Drug: G-Pump™ (glucagon infusion)
Novo Nordisk GlucaGen®	Active comparator	Novo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg Receives: Drug: Novo Nordisk GlucaGen®; Drug: G-Pump™ (glucagon infusion)

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)
The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.
Measured: 0 to 150 minutes post-dosing
Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)
The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.
Measured: 0 to 150 minutes post-dosing

Secondary outcomes (8)

Glucagon Cmax
Maximum plasma concentration of glucagon
Measured: From 0 to 150 minutes post-dosing
Glucose Cmax
Maximum plasma concentration of glucose
Measured: From 0 to 150 minutes post-dosing
Glucagon Tmax
Time to maximum plasma concentration of glucagon
Measured: From 0 to 150 minutes post-dosing
Glucose Tmax
Time to maximum plasma concentration of glucose
Measured: From 0 to 150 minutes post-dosing
Glucagon AUC
Area under the plasma concentration time curve for glucagon
Measured: From 0 to 150 minutes post-dosing
Glucose AUC
Area under the plasma concentration time curve for glucose
Measured: From 0 to 150 minutes post-dosing
Infusion Site Discomfort Score at 10 Minutes
Infusion site discomfort was assessed by the subjects using a 100 mm Visual Analog Scale (VAS) questionnaire at 10 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.
Measured: At 10 minutes post-dosing
Infusion Site Discomfort Score at 30 Minutes
Infusion site discomfort was assessed by the subject using a 100 mm Visual Analog Scale (VAS) questionnaire at 30 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.
Measured: At 30 minutes post-dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Sep 2014

First posted7 Mar 2014 (estimated)
Study startMar 2014
Primary completionAug 2014
Study completionSep 2014

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 HypoglycemiaStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02081001
Sponsor's protocol ID: XSGO-201
Other IDs: 4R44DK096706-02
Status last verified: Mar 2018
First submitted: 4 Mar 2014
Last updated: 6 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Pharmacokinetic and Pharmacodynamic Profiles of G-Pump™ (Glucagon Infusion) vs. GlucaGen® Delivered Subcutaneously to Subjects With Type 1 Diabetes (T1DM)
ClinicalTrials.gov ID: NCT02081001
Acronym / sponsor ID: XSGO-201
Conditions: Hypoglycemia
Keywords: Hypoglycemia, Glucagon, Artificial Pancreas
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Xeris PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emissary International LLC
Study start: Mar 2014
Primary completion: Aug 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 7 Mar 2014 (estimated)
Results: Posted 1 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
G-Pump™ (glucagon infusion)	Experimental	Drug: Novo Nordisk GlucaGen®, Drug: G-Pump™ (glucagon infusion)G-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
Novo Nordisk GlucaGen®	Active comparator	Drug: Novo Nordisk GlucaGen®, Drug: G-Pump™ (glucagon infusion)Novo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Males or females diagnosed with type 1 diabetes mellitus for at least 24 months
Current usage of subcutaneous insulin pump treatment
Age 18-65 years
C-peptide level < 0.5 ng/ml
Willingness to follow all study procedures, including attending all clinic visits

Key exclusion criteria (25 listed)

Pregnant and/ or Lactating: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study.
HbA1c >10.0%
Renal insufficiency (serum creatinine of 1.2 mg/dL or greater)
Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL; or serum bilirubin of over 2.0.
Hematocrit of less than or equal to 34%

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
Novo Nordisk GlucaGen®single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg	Drug	G-Pump™ (glucagon infusion), Novo Nordisk GlucaGen®
G-Pump™ (glucagon infusion)single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg	Drug	G-Pump™ (glucagon infusion), Novo Nordisk GlucaGen®

Primary outcome

Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)
Time frame: 0 to 150 minutes post-dosing
The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.
Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)
Time frame: 0 to 150 minutes post-dosing
The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.

8 secondary outcomes

Glucagon Cmax
Time frame: From 0 to 150 minutes post-dosing
Glucose Cmax
Time frame: From 0 to 150 minutes post-dosing
Glucagon Tmax
Time frame: From 0 to 150 minutes post-dosing
Glucose Tmax
Time frame: From 0 to 150 minutes post-dosing
Glucagon AUC
Time frame: From 0 to 150 minutes post-dosing
Glucose AUC
Time frame: From 0 to 150 minutes post-dosing
Infusion Site Discomfort Score at 10 Minutes
Time frame: At 10 minutes post-dosing
Infusion Site Discomfort Score at 30 Minutes
Time frame: At 30 minutes post-dosing

Results and safety

Results posted to the registry on 1 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: G-Pump/GlucaGen	2	2
Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: GlucaGen/G-Pump	1	1
Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen	2	2
Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump	1	1
Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: G-Pump/GlucaGen	3	2
Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: GlucaGen/G-Pump	1	1
Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen	2	2
Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump	1	1
Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen	2	2
Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump	1	1
Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen	2	2
Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump	1	1

Primary outcome: Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)

Time frame: 0 to 150 minutes post-dosing. Mean (Standard Deviation). Unit: minutes

Measure	0.3 μg/kg G-Pump n = 14	1.2 μg/kg G-Pump n = 18	2.0 μg/kg G-Pump n = 19	0.3μg/kg GlucaGen n = 11	1.2 μg/kg GlucaGen n = 16	2.0 μg/kg GlucaGen n = 16
Value	17.2 (8.76)	21.9 (18.44)	21.3 (16.52)	7.6 (9.45)	14.5 (15.36)	22.8 (6.51)

0.3 μg/kg G-Pump vs 0.3μg/kg GlucaGen: Point estimate ratio: 2.06 (90% CI 0.74 to 5.75), p = 0.23, Mixed Models Analysis
1.2 μg/kg G-Pump vs 1.2 μg/kg GlucaGen: Point estimate ratio: 1.25 (90% CI 0.69 to 2.28), p = 0.52, Mixed Models Analysis
2.0 μg/kg G-Pump vs 2.0 μg/kg GlucaGen: Point estimate ratio: 0.86 (90% CI 0.59 to 1.25), p = 0.49, Mixed Models Analysis

Population analysed: All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.

Primary outcome: Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)

Time frame: 0 to 150 minutes post-dosing. Mean (Standard Deviation). Unit: minutes

Measure	0.3 μg/kg G-Pump n = 19	1.2 μg/kg G-Pump n = 19	2.0 μg/kg G-Pump n = 19	0.3 μg/kg GlucaGen n = 16	1.2 μg/kg GlucaGen n = 16	2.0 μg/kg GlucaGen n = 16
Value	12.2 (10.51)	12.4 (5.07)	13.9 (4.65)	7.6 (3.51)	10.5 (4.46)	11.0 (3.09)

0.3 μg/kg G-Pump vs 0.3 μg/kg GlucaGen: Point estimate ratio: 1.37 (90% CI 0.88 to 2.12), p = 0.23, Mixed Models Analysis
1.2 μg/kg G-Pump vs 1.2 μg/kg GlucaGen: Point estimate ratio: 1.29 (90% CI 1.01 to 1.65), p = 0.09, Mixed Models Analysis
2.0 μg/kg G-Pump vs 2.0 μg/kg GlucaGen: Point estimate ratio: 1.36 (90% CI 1.11 to 1.67), p = 0.02, Mixed Models Analysis

Population analysed: All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event information was collected from the time a subject provided written informed consent at the screening visit through the follow-up visit occurring 3-14 days after the final dose of study drug, a total time of 6-10 weeks per subject.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
G-Pump™ (Glucagon Infusion)	0 of 19 (0%)	16 of 19 (84.2%)	Not reported
Novo Nordisk GlucaGen®	0 of 18 (0%)	12 of 18 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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.

Jessica Castle, MD principal investigator

Oregon Health and Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Novo Nordisk GlucaGen® and G-Pump™ (glucagon infusion) in people with Hypoglycemia, run by Xeris Pharmaceuticals 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 6 inclusion and 25 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 6 Apr 2018. 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 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.

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 1 Aug 2016). 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?

Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early) (time frame: 0 to 150 minutes post-dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02081001.

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 6 Apr 2018.