ClinicalTrials.gg
CompletedNCT03439072Updated Feb 17, 2020Results posted

G-Pen™ Compared to Lilly Glucagon for Hypoglycemia Rescue in Adults With Type 1 Diabetes

A Phase 3 interventional study of G-Pen and Lilly Glucagon in Insulin Hypoglycemia, Type 1 Diabetes Mellitus and Severe Hypoglycemia, sponsored by Xeris Pharmaceuticals. Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Xeris Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 34 studies testing glucagon in Diabetes Mellitus, Type 1 — 1 open to participants now, 1 under way, none of them phase 3. Glucagon · Diabetes Mellitus, Type 1.

Enrollment
3rd of 34
81 · median 17
Started
2018
with 3 others
Phase 3
7 of 34
none open now
Registered
23rd of 34
by date
Lead sponsor
5 of 34
Xeris Pharmaceuticals

Among the 34 studies testing glucagon in Diabetes Mellitus, Type 1, this one is the 3rd largest by enrollment, is one of 4 that started in 2018, is one of 7 in phase 3, and was the 23rd registered.

By phase

34 studies; the count open now beside each. This study's row is marked.

Phase 29 · 0 open
No phase7 · 0 open
Phase 3this study7 · 0 open
Phase 16 · 0 open
Phase 44 · 1 open
Phase 2/31 · 0 open

By the year they started

First in 2006; this study’s year is marked. 4 started in 2018.

Tested beside glucagon

Size and results

Median enrollment 17 across the 34 interventional studies. Of the 28 that completed or were terminated, 20 (71%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 34 studies testing glucagon in Diabetes Mellitus, Type 1, or all of them as a file.
02

Study summary

This is a non-inferiority, multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen™ glucagon 1 mg during one period and Lilly Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose \< 50 mg/dL is verified, the subject is administered a dose of G-Pen or Lilly Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of >70.0 mg/dL within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedure are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug.

03

Conditions studied

  • Insulin Hypoglycemia
  • Type 1 Diabetes Mellitus
  • Severe Hypoglycemia

Keywords

  • glucagon
  • hypoglycemia
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males and females diagnosed with type 1 diabetes mellitus for at least 24 months.
  2. Current usage of daily insulin treatment that includes having an assigned "correction factor" for managing hyperglycemia.
  3. Age 18-75 years, inclusive.
  4. Random serum C-peptide concentration \< 0.5 ng/mL.
  5. Willingness to follow all study procedures, including attending all clinic visits.
  6. Subject has provided as evidenced by a signed/dated informed consent form completed before any trial-related activities occur.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy: For women of , there is a requirement for a negative urine pregnancy test and for agreement to use throughout the study and for 7 days after the last dose of study glucagon. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
  2. Breastfeeding: Nursing mothers will be allowed into the study. However, breast feeding during the during inpatient study visits and for 48 hours after each dose of study drug is not allowed.
  3. >9.0% at Screening.
  4. > 40 kg/m2.
  5. Renal insufficiency (serum creatinine greater than 3.0 mg/dL) or end-stage renal disease. requiring renal replacement therapy.
  6. Serum or AST equal to or greater than 3 times the .
  7. Hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL.
  8. Hematocrit of less than or equal to 30%.
  9. BP readings at Screening where SBP \<90 or >150 mm Hg, and DBP \<50 or >100 mm Hg.
  10. abnormalities.
  11. Use of > 2.0 U/kg total insulin dose per day.
  12. Inadequate venous access.
  13. Congestive heart failure, class III or IV.
  14. History of myocardial infarction, unstable angina, or revascularization within the past 6 months.
  15. History of a cerebrovascular accident in past 6 months or with major neurological deficits.
  16. Active within 5 years from Screening, except basal cell or squamous cell skin cancers. History of breast cancer or malignant melanoma will be exclusionary.
  17. Major surgical operation within 30 days prior to Screening.
  18. Current seizure disorder (other than with suspect or documented hypoglycemia).
  19. Current bleeding disorder, treatment with warfarin, or count below 50 x 10e9 per liter.
  20. History of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease).
  21. History of insulinoma.
  22. History of allergies to glucagon or glucagon-like products, or any history of significant to glucagon or any related products or to any of the (DMSO \& trehalose) in the formulation.
  23. History of glycogen storage disease.
  24. Subject tests positive for , or infection (HBsAg+) at Screening.
  25. Active substance or alcohol abuse (more than 21 drinks/wk. for males or 14 drinks/wk. for females). Subjects reporting active marijuana use or testing positive for tetrahydrocannabinol (THC) via rapid urine test will be allowed to participate in the study at the discretion of the Investigator.
  26. Administration of glucagon within 28 days of Screening.
  27. Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before Screening for the current study and during participation in the current study.
  28. Any reason the Investigator deems exclusionary.
Terms in these criteria, in plain language(18)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
81 participants (actual)

Study arms

  • Other
    G-Pen followed by Lilly Glucagon

    1 mg G-Pen at the first treatment visit followed by 1 mg Lilly Glucagon at the second treatment visit

    Drug: G-Pen · Drug: Lilly Glucagon

  • Other
    Lilly Glucagon followed by G-Pen

    1 mg Lilly Glucagon at the first treatment visit followed by 1 mg G-Pen at the second treatment visit

    Drug: G-Pen · Drug: Lilly Glucagon

Interventions

  • DrugG-Pen

    1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector

    Also known as: glucagon

  • DrugLilly Glucagon

    1 mg subcutaneous injection of Lilly Glucagon (glucagon injection \[RNDA Origin\])

    Also known as: GEK

06

What researchers measure

Primary outcomes

  1. Number of Subjects With a Positive Glucose Response

    Increase in plasma glucose concentration from below 50.0 mg/dL to greater than 70.0 mg/dL within 30 minutes after receiving glucagon

    Time frame: 0 to 30 minutes post dose

Secondary outcomes

  1. Time for Positive Glucose Response

    Time from administration of glucagon for plasma glucose to rise from below 50.0 mg/dL to above 70.0 mg/dL

    Time frame: 0 to 180 minutes post dose

  2. Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase

    A positive response for this endpoint is a return of plasma glucose to \> 70 mg/dL or an increase in plasma glucose by ≥20 mg/dL within 30 minutes after receiving glucagon

    Time frame: 0 to 30 minutes post dose

  3. Number of Subjects With a Positive Glucose Increase

    Increase in plasma glucose by ≥ 20.0 mg/dL within 30 minutes after receiving glucagon

    Time frame: 0 to 30 minutes post dose

  4. Time for Positive Glucose Increase

    Time from administration of glucagon for plasma glucose to increase by ≥20 mg/dL from baseline

    Time frame: 0 to 180 minutes post dose

  5. Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms

    A positive response for this endpoint is a return of plasma glucose to \> 70 mg/dL or clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness.

    Time frame: 0 to 30 minutes post dose

  6. Number of Subjects With Relief of Neuroglycopenic Symptoms

    Clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness.

    Time frame: 0 to 30 minutes post dose

  7. Time to Resolution of Autonomic Symptoms

    Time from administration of glucagon to complete resolution of 4 autonomic symptoms of hypoglycemia. Symptoms included: sweating, tremor, palpitations and feeling of nervousness.

    Time frame: 0 to 180 minutes post dose

  8. Time to Resolution of Neuroglycopenic Symptoms

    Time from administration of glucagon to complete resolution of 4 neuroglycopenic symptoms of hypoglycemia. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness.

    Time frame: 0 to 180 minutes post dose

  9. Time to Resolution of the Feeling of Hypoglycemia

    Time from administration of glucagon to resolution of the overall sensation of hypoglycemia. Subjects were asked to answer yes/no to the question, "Do you feel hypoglycemic?" The time point as which the subject first answered "no" was considered the time of resolution.

    Time frame: 0 to 180 minutes post dose

  10. Glucose AUC

    Area under the curve for plasma glucose.

    Time frame: 0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.

  11. Glucose Cmax

    Maximum concentration of plasma glucose.

    Time frame: 0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.

  12. Glucose Tmax

    Time to maximum concentration of plasma glucose. Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.

    Time frame: 0 to 180 minutes post dose

  13. Glucagon Preparation and Administration Time

    Time required to prepare and inject glucagon as measured between a "decision to dose" and completion of the injection

    Time frame: 0 to 5 minutes pre-dose

07

Results

Posted May 30, 2019

Participant flow

The recruitment period began 08 Jan 2018 and ran through 02 Apr 2018. Subjects were screened for study eligibility at one of the six clinical sites up to 30 days prior to randomization.

Participant flow — Overall Study
MilestoneG-Pen Followed by Lilly GlucagonLilly Glucagon Followed by G-Pen
Started4140
Completed3936
Not completed24
Withdrew: Withdrawal by subject23
Withdrew: Physician decision01

Outcome measures

PrimaryNumber of Subjects With a Positive Glucose Response

Increase in plasma glucose concentration from below 50.0 mg/dL to greater than 70.0 mg/dL within 30 minutes after receiving glucagon

Time frame:
0 to 30 minutes post dose
Reported as:
Count of participants · Participants
Number of Subjects With a Positive Glucose Response
ParticipantsG-PenLilly Glucagon
Number of Subjects With a Positive Glucose Response7678
SecondaryTime for Positive Glucose Response

Time from administration of glucagon for plasma glucose to rise from below 50.0 mg/dL to above 70.0 mg/dL

Time frame:
0 to 180 minutes post dose
Reported as:
Mean · minutes
Time for Positive Glucose Response
minutesG-PenLilly Glucagon
Time for Positive Glucose Response12.17 ± 3.6048.58 ± 2.026
SecondaryNumber of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase

A positive response for this endpoint is a return of plasma glucose to \> 70 mg/dL or an increase in plasma glucose by ≥20 mg/dL within 30 minutes after receiving glucagon

Time frame:
0 to 30 minutes post dose
Reported as:
Count of participants · Participants
Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase
ParticipantsG-PenLilly Glucagon
Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase7678
SecondaryNumber of Subjects With a Positive Glucose Increase

Increase in plasma glucose by ≥ 20.0 mg/dL within 30 minutes after receiving glucagon

Time frame:
0 to 30 minutes post dose
Reported as:
Count of participants · Participants
Number of Subjects With a Positive Glucose Increase
ParticipantsG-PenLilly Glucagon
Number of Subjects With a Positive Glucose Increase7678
SecondaryTime for Positive Glucose Increase

Time from administration of glucagon for plasma glucose to increase by ≥20 mg/dL from baseline

Time frame:
0 to 180 minutes post dose
Reported as:
Mean · minutes
Time for Positive Glucose Increase
minutesG-PenLilly Glucagon
Time for Positive Glucose Increase11.36 ± 3.3458.02 ± 1.856
SecondaryNumber of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms

A positive response for this endpoint is a return of plasma glucose to \> 70 mg/dL or clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness.

Time frame:
0 to 30 minutes post dose
Reported as:
Count of participants · Participants
Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms
ParticipantsG-PenLilly Glucagon
Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms7678
SecondaryNumber of Subjects With Relief of Neuroglycopenic Symptoms

Clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness.

Time frame:
0 to 30 minutes post dose
Reported as:
Count of participants · Participants
Number of Subjects With Relief of Neuroglycopenic Symptoms
ParticipantsG-PenLilly Glucagon
Number of Subjects With Relief of Neuroglycopenic Symptoms7477
SecondaryTime to Resolution of Autonomic Symptoms

Time from administration of glucagon to complete resolution of 4 autonomic symptoms of hypoglycemia. Symptoms included: sweating, tremor, palpitations and feeling of nervousness.

Time frame:
0 to 180 minutes post dose
Reported as:
Mean · minutes
Time to Resolution of Autonomic Symptoms
minutesG-PenLilly Glucagon
Time to Resolution of Autonomic Symptoms13.8 ± 10.8912.0 ± 7.44
SecondaryTime to Resolution of Neuroglycopenic Symptoms

Time from administration of glucagon to complete resolution of 4 neuroglycopenic symptoms of hypoglycemia. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness.

Time frame:
0 to 180 minutes post dose
Reported as:
Mean · minutes
Time to Resolution of Neuroglycopenic Symptoms
minutesG-PenLilly Glucagon
Time to Resolution of Neuroglycopenic Symptoms14.2 ± 15.1212.2 ± 8.85
SecondaryTime to Resolution of the Feeling of Hypoglycemia

Time from administration of glucagon to resolution of the overall sensation of hypoglycemia. Subjects were asked to answer yes/no to the question, "Do you feel hypoglycemic?" The time point as which the subject first answered "no" was considered the time of resolution.

Time frame:
0 to 180 minutes post dose
Reported as:
Mean · minutes
Time to Resolution of the Feeling of Hypoglycemia
minutesG-PenLilly Glucagon
Time to Resolution of the Feeling of Hypoglycemia11.6 ± 6.4513.1 ± 7.86
SecondaryGlucose AUC

Area under the curve for plasma glucose.

Time frame:
0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.
Reported as:
Mean · mg∙min/dL
Glucose AUC
mg∙min/dLG-PenLilly Glucagon
Glucose AUC33686.04 ± 5300.20433538.60 ± 5705.219
SecondaryGlucose Cmax

Maximum concentration of plasma glucose.

Time frame:
0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.
Reported as:
Mean · mg/dL
Glucose Cmax
mg/dLG-PenLilly Glucagon
Glucose Cmax238.32 ± 45.626228.11 ± 46.567
SecondaryGlucose Tmax

Time to maximum concentration of plasma glucose. Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.

Time frame:
0 to 180 minutes post dose
Reported as:
Mean · minutes
Glucose Tmax
minutesG-PenLilly Glucagon
Glucose Tmax125.67 ± 33.513113.89 ± 31.908
SecondaryGlucagon Preparation and Administration Time

Time required to prepare and inject glucagon as measured between a "decision to dose" and completion of the injection

Time frame:
0 to 5 minutes pre-dose
Reported as:
Mean · seconds
Glucagon Preparation and Administration Time
secondsG-PenLilly Glucagon
Glucagon Preparation and Administration Time27.3 ± 19.6697.2 ± 45.06

Adverse events

Collected over Adverse events were collected for up to 9 weeks, from the time of consent through the follow-up visit.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
G-Pen0/76 (0%)0/76 (0%)46/76 (60.5%)
Lilly Glucagon0/78 (0%)0/78 (0%)34/78 (43.6%)
Most frequent other events
Most frequent other events
EventG-PenLilly Glucagon
NauseaGastrointestinal disorders29/7626/78
VomitingGastrointestinal disorders20/7611/78
HeadacheNervous system disorders6/764/78

Baseline characteristics

All randomized subjects

Age, Continuous
Age, Continuous(years)All Randomized Subjects
Mean38.2 ± 14.6
Sex: Female, Male
Sex: Female, Male(Participants)All Randomized Subjects
Female37
Male44
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Randomized Subjects
Hispanic or Latino6
Not Hispanic or Latino75
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Randomized Subjects
American Indian or Alaska Native0
Asian6
Native Hawaiian or Other Pacific Islander0
Black or African American0
White71
More than one race3
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)All Randomized Subjects
North America81
08

Study locations

6 sites
  • ProSciento, Inc.
    Chula Vista, California 91911, United States
  • Diablo Clinical Research, Inc.
    Walnut Creek, California 94598, United States
  • Atlanta Diabetes Associates
    Atlanta, Georgia 30318, United States
  • Rainier Clinical Research Center, Inc.
    Renton, Washington 98057, United States
  • LMC ESD, Inc.
    Toronto, Ontario M4G 3E8, Canada
  • Altasciences Algorithme Pharma
    Montréal, Quebec H3P 3P1, Canada
09

References and documents

Publications

  • Christiansen MP, Cummins M, Prestrelski S, Close NC, Nguyen A, Junaidi K. Comparison of a ready-to-use liquid glucagon injection administered by autoinjector to glucagon emergency kit for the symptomatic relief of severe hypoglycemia: two randomized crossover non-inferiority studies. BMJ Open Diabetes Res Care. 2021 Oct;9(1):e002137. doi: 10.1136/bmjdrc-2021-002137. PubMed 34620618 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Apr 2018, 2 months.

Results were first posted in May 2019, 1 year 1 month after primary completion.

Of 78 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 25. This study's 2 months is below that.

Counting every sponsor, half of 106 studies reached it within 18 months; a quarter within 10 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2018
First posted
Feb 20, 2018
StartActual
Jan 23, 2018
Primary completionActual
Apr 18, 2018
CompletionActual
May 3, 2018
Results first posted
May 30, 2019
Last update
Feb 17, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03439072
Lead sponsor
Xeris Pharmaceuticals
Collaborators
SGS S.A., Integrated Medical Development
Responsible party
Sponsor
First posted
Feb 20, 2018
Start date
Jan 23, 2018
Primary completion
Apr 18, 2018
Completion
May 3, 2018
Results posted
May 30, 2019
Last update
Feb 17, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Glucagon

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