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
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.
Exclusion Criteria:
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 |
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Xeris Pharmaceuticals