A Phase 3 interventional study of G-Pen and Novo Glucagon in Insulin Hypoglycemia, Type 1 Diabetes Mellitus and Severe Hypoglycemia, sponsored by Xeris Pharmaceuticals. Completed at 7 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-22.
Sponsored by Xeris Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
Among the 34 studies testing glucagon in Diabetes Mellitus, Type 1, this one has the largest enrollment, is one of 4 that started in 2018, is one of 7 in phase 3, and was the 25th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's enrollment of 132 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →1 of the 34 studies testing glucagon in Diabetes Mellitus, Type 1 is open now, in 1 country. Each count lists the studies.
Glucagon: first FDA approval 1960 (GLUCAGON), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →34 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 4 started in 2018.
Median enrollment 17 across the 34 interventional studies. Of the 28 that completed or were terminated, 20 (71%) have results posted.
14 of 34 have an industry lead sponsor. The 10 most frequent:
Xeris Pharmaceuticals is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 9 (90%) have results posted.
Xeris Pharmaceuticals has 6 studies filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
1 of the studies testing glucagon in Diabetes Mellitus, Type 1 that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07427251Steno Diabetes Center CopenhagenThe Postprandial Hypo-Avoid Study | 2027-05-01 |
Among the 34 studies testing glucagon in Diabetes Mellitus, Type 1, from their registry updates:
Nothing recorded among them since 2026-09-25.
This is a 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 Novo 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 severe hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose \< 54 mg/dL (3 mmol/L) is verified, the subject is administered a dose of G-Pen or Novo Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of >70.0 mg/dL (3.89 mmol/L) or an increase of > 20 mg/dL (>1.11 mmol/L) 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 procedures 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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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 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 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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 mg G-Pen at the first treatment visit followed by 1 mg Novo Glucagon at the second treatment visit
Drug: G-Pen · Drug: Novo Glucagon
1 mg Novo Glucagon at the first treatment visit followed by 1 mg G-Pen at the second treatment visit
Drug: G-Pen · Drug: Novo Glucagon
1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Also known as: glucagon
1 mg subcutaneous injection of Novo Glucagon (glucagon injection)
Also known as: Glucagen Hypokit
Severe Hypoglycemia Rescue
Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) within 30 minutes after administration of glucagon
Time frame: At 30 minutes following administration of study drug
Plasma Glucose Response 1
Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) within 30 minutes of a decision to dose
Time frame: At 30 minutes following a decision to administer study drug
Plasma Glucose Response 2
Number of subjects with an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) after administration of glucagon.
Time frame: At 0-30 minutes following a decision to administer study drug
Administration Time
Mean time (minutes) to administer study drug from a decision to dose
Time frame: At 0-10 minutes from a decision to administer study drug
Hypoglycemia Resolution
Mean time (minutes) to complete resolution of the overall sensation of hypoglycemia from a decision to dose
Time frame: At 0-90 minutes following administration of study drug
| Milestone | G-Pen, Then Novo Glucagon | Novo Glucagon, Then G-Pen |
|---|---|---|
| Started | 66 | 66 |
| Completed | 61 | 62 |
| Not completed | 5 | 4 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Physician decision | 0 | 1 |
Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) within 30 minutes after administration of glucagon
| Participants | G-Pen | Novo Glucagon |
|---|---|---|
| Severe Hypoglycemia Rescue | 127 | 123 |
Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) within 30 minutes of a decision to dose
| Participants | G-Pen | Novo Glucagon |
|---|---|---|
| Plasma Glucose Response 1 | 127 | 123 |
Number of subjects with an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) after administration of glucagon.
| Participants | G-Pen | Novo Glucagon |
|---|---|---|
| Plasma Glucose Response 2 | 127 | 123 |
Mean time (minutes) to administer study drug from a decision to dose
| minutes | G-Pen | Novo Glucagon |
|---|---|---|
| Administration Time | 0.79 ± 0.530 | 1.76 ± 0.678 |
Mean time (minutes) to complete resolution of the overall sensation of hypoglycemia from a decision to dose
| minutes | G-Pen | Novo Glucagon |
|---|---|---|
| Hypoglycemia Resolution | 15.69 ± 7.428 | 15.32 ± 8.479 |
Collected over Adverse events were collected for up to 5 weeks, from the time of consent through the follow-up visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| G-Pen | 0/127 (0%) | 0/127 (0%) | 67/127 (52.8%) |
| Novo Glucagon | 0/123 (0%) | 0/123 (0%) | 57/123 (46.3%) |
| Event | G-Pen | Novo Glucagon |
|---|---|---|
| NauseaGastrointestinal disorders | 54/127 | 55/123 |
| VomitingGastrointestinal disorders | 16/127 | 17/123 |
| HeadacheNervous system disorders | 7/127 | 9/123 |
All Randomized Population
| Age, Categorical(Participants) | G-Pen, Then Novo Glucagon | Novo Glucagon, Then G-Pen | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 63 | 63 | 126 |
| >=65 years | 3 | 3 | 6 |
| Sex: Female, Male(Participants) | G-Pen, Then Novo Glucagon | Novo Glucagon, Then G-Pen | Total |
|---|---|---|---|
| Female | 29 | 33 | 62 |
| Male | 37 | 33 | 70 |
| Ethnicity (NIH/OMB)(Participants) | G-Pen, Then Novo Glucagon | Novo Glucagon, Then G-Pen | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 |
| Not Hispanic or Latino | 65 | 63 | 128 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | G-Pen, Then Novo Glucagon | Novo Glucagon, Then G-Pen | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 0 | 2 | 2 |
| White | 62 | 61 | 123 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2018 to primary completion in Mar 2019, 6 months.
Results were first posted in May 2020, 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 6 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.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Glucagon
Xeris Pharmaceuticals