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CompletedNCT02081014Updated Apr 5, 2018Results posted

Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes

A Phase 2 interventional study of G-Pen Mini™ (glucagon injection) in Hypoglycemia, sponsored by Xeris Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by Xeris Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to moderate hypoglycemia, a complication of diabetes.

02

Conditions studied

  • Hypoglycemia

Browse trials for

Keywords

  • Hypoglycemia
  • Glucagon
  • Diabetes
03

In context

Hypoglycemia

640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.

This study's enrollment of 13 is below the median of 29 across 471 interventional studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male and female subjects on insulin infusion pump therapy for treatment of type 1 diabetes
  2. Between the ages of 18 and 50 years of age, inclusive, at Screening.
  3. Females of childbearing potential with a negative serum pregnancy test prior at screening and negative urine pregnancy tests prior to the Treatment visits, using an approved forms of contraception for the duration of participation in the study (i.e. until after last dose).
  4. Male subjects are required to use a condom and another of the methods of contraception in #3 above starting at Randomization and for the duration of the study.
  5. Hemoglobin A1c (HbA1c) \< 9.0 %.
  6. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  7. Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Clinical evidence of microvascular complication(s) other than mild microalbuminuria or history of mild non-proliferative retinopathy
  2. Any chronic diseases or illness that interferes with glucose metabolism, except for T1DM, or medications other than hypothyroidism on appropriate thyroid hormone replacement.
  3. Blood pressure (BP) readings at Screening where Systemic BP \<90 or >140 mm Hg, and Diastolic BP \<50 or >90 mm Hg.
  4. Cardiovascular event within 6 months prior to screening such as unstable angina, acute coronary syndrome, myocardial infarction, therapeutic coronary procedure (e.g., stent placement, Percutaneous Transluminal Coronary Angioplasty (PTCA), Coronary Artery By-pass Grafting (CABG)), stroke or transient ischemic attack.
  5. Study participants who are pregnant at Screening.
  6. Breast feeding must be discontinued if a subject wishes to participate in this study.
  7. Positive test for hepatitis B, hepatitis C, or HIV found at Screening.
  8. Positive urine drug test for illicit drugs at Screening.
  9. History of allergies to glucagon, glucagon-like products or to any of the excipients in the investigational formulation.
  10. Known presence of hereditary problems of glycogen storage disease, galactose and /or lactose intolerance
  11. Administration of glucagon more than once within the three (3) months prior to Screening

  12. Subjects with any of the following abnormalities in clinical laboratory tests at Screening, confirmed by a single repeat, if necessary:

    • Hemoglobin (Hb) below the lower limits of normal for the laboratory
    • Total bilirubin above the upper limits of normal for the laboratory
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above the upper limits of normal for the laboratory
    • Creatinine above the upper limits of normal for the laboratory
  13. History of regular alcohol consumption as defined by alcohol intake in a quantity exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor.
  14. 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
  15. Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed red blood cells, platelets or quantities less than 500 mL are allowed at investigator discretion.
  16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    G-Pen Mini™ (glucagon injection) 75 ug

    G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart

    Drug: G-Pen Mini™ (glucagon injection)

  • Experimental
    G-Pen Mini™ (glucagon injection) 150 ug

    G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart

    Drug: G-Pen Mini™ (glucagon injection)

  • Experimental
    G-Pen Mini™ (glucagon injection) 300 ug

    G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart

    Drug: G-Pen Mini™ (glucagon injection)

Interventions

  • DrugG-Pen Mini™ (glucagon injection)

    stable, pre-mixed, liquid glucagon for subcutaneous injection

    Also known as: mini-dose glucagon

06

What researchers measure

Primary outcomes

  1. Serious Adverse Events

    Number of serious adverse events (SAEs) per treatment

    Time frame: From first dose until follow-up call, up to 7 weeks per subject

Secondary outcomes

  1. Glucagon Cmax (Fasting)

    Pharmacokinetic parameter: Maximum concentration of glucagon

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection

  2. Glucagon Cmax (Post-insulin)

    Pharmacokinetic parameter: Maximum concentration of glucagon

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

  3. Glucagon Area Under the Curve (AUC) (Fasting)

    Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

  4. Glucagon AUC (Post-insulin)

    Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

  5. Glucagon Tmax (Fasting)

    Pharmacokinetic parameter: Time to reach maximum concentration of glucagon

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection

  6. Glucagon Tmax (Post-insulin)

    Pharmacokinetic parameter: Time to reach maximum concentration of glucagon

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

  7. Glucose Cmax (Fasting)

    Pharmacodynamic parameter: Maximum concentration of glucose

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection

  8. Glucose Cmax (Post-insulin)

    Pharmacodynamic parameter: Maximum concentration of glucose

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

  9. Glucose AUC (Fasting)

    Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

  10. Glucose AUC (Post-insulin)

    Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

  11. Glucose Tmax (Fasting)

    Pharmacodynamic parameter: Time to reach maximum concentration of glucose

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection

  12. Glucose Tmax (Post-insulin)

    Pharmacodynamic parameter: Time to reach maximum concentration of glucose

    Time frame: Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection

07

Results

Posted May 16, 2016

Participant flow

A total of 13 adults \< 50 years of age with type 1 diabetes were recruited over a period of 5 months to receive treatment at a university-affiliated state hospital-based endocrinology clinic.

Participant flow — Overall Study
MilestoneG-Pen Mini™ Dose Order: 75, 150 & 300 MicrogramsG-Pen Mini™ Dose Order: 75, 300 & 150 MicrogramsG-Pen Mini™ Dose Order: 150, 75 & 300 MicrogramsG-Pen Mini™ Dose Order: 150, 300 & 75 MicrogramsG-Pen Mini™ Dose Order: 300, 75 & 150 MicrogramsG-Pen Mini™ Dose Order: 300, 150 & 75 Micrograms
Started222222
Completed222222
Not completed000000

Outcome measures

PrimarySerious Adverse Events

Number of serious adverse events (SAEs) per treatment

Time frame:
From first dose until follow-up call, up to 7 weeks per subject
Reported as:
Number · participants
Serious Adverse Events
participantsG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Serious Adverse Events000
SecondaryGlucagon Cmax (Fasting)

Pharmacokinetic parameter: Maximum concentration of glucagon

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Reported as:
Mean · pg/ml
Glucagon Cmax (Fasting)
pg/mlG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucagon Cmax (Fasting)233.8 ± 34380.7 ± 34663.6 ± 34
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.62Geometric means
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.35Geometric means
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.57Geometric means
SecondaryGlucagon Cmax (Post-insulin)

Pharmacokinetic parameter: Maximum concentration of glucagon

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Reported as:
Mean · pg/ml
Glucagon Cmax (Post-insulin)
pg/mlG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucagon Cmax (Post-insulin)253.4 ± 30.1335.4 ± 30.1561.7 ± 29.9
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.74Geometric means
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.44Geometric means
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.59Geometric means
SecondaryGlucagon Area Under the Curve (AUC) (Fasting)

Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Reported as:
Mean · (pg/ml)*hour
Glucagon Area Under the Curve (AUC) (Fasting)
(pg/ml)*hourG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucagon Area Under the Curve (AUC) (Fasting)265.4 ± 35.4389.6 ± 35.4735.3 ± 35.4
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = <0.05 · Point point ratio: 0.68Geometric means
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.36Geometric means
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.53Geometric means
SecondaryGlucagon AUC (Post-insulin)

Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Reported as:
Mean · (pg/ml)*hour
Glucagon AUC (Post-insulin)
(pg/ml)*hourG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucagon AUC (Post-insulin)277.4 ± 29.9386.8 ± 29.9635.3 ± 29.7
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.72Geometric means
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.44Geometric means
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.60Geometric means
SecondaryGlucagon Tmax (Fasting)

Pharmacokinetic parameter: Time to reach maximum concentration of glucagon

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Reported as:
Mean · minutes
Glucagon Tmax (Fasting)
minutesG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucagon Tmax (Fasting)29.2 ± 3.629.8 ± 3.636.5 ± 3.6
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = >0.05 · Point esimate ratio: 0.98Geometric means
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = >0.05 · Point estimate ratio: 0.78Geometric means
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = >0.05 · Point estimate ratio: 0.79Geometric means
SecondaryGlucagon Tmax (Post-insulin)

Pharmacokinetic parameter: Time to reach maximum concentration of glucagon

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Reported as:
Mean · minutes
Glucagon Tmax (Post-insulin)
minutesG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucagon Tmax (Post-insulin)24 ± 2.733.1 ± 2.734.1 ± 2.7
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = >0.05 · Point estimate ratio: 0.75Geometric means
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.73Geometric means
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = >0.05 · Point estimate ratio: 0.96Geometric means
SecondaryGlucose Cmax (Fasting)

Pharmacodynamic parameter: Maximum concentration of glucose

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Reported as:
Mean · mg/dl
Glucose Cmax (Fasting)
mg/dlG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucose Cmax (Fasting)155.1 ± 11.2186.2 ± 11.1213.5 ± 11.2
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.82Geometric means
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.70Geometric means
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.85Geometric means
SecondaryGlucose Cmax (Post-insulin)

Pharmacodynamic parameter: Maximum concentration of glucose

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Reported as:
Mean · mg/dl
Glucose Cmax (Post-insulin)
mg/dlG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucose Cmax (Post-insulin)99.7 ± 8.6105.7 ± 8.6122.6 ± 8.4
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = >0.05 · Point estimate ratio: 0.96Geometric means
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Point estimate ratio: 0.83Geometric means
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = >0.05 · Point estimate ratio: 0.86Geometric means
SecondaryGlucose AUC (Fasting)

Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Reported as:
Mean · (mg/dl)*minutes
Glucose AUC (Fasting)
(mg/dl)*minutesG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucose AUC (Fasting)4872.0 ± 1495.98565.2 ± 1492.812420.0 ± 1500.6
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = <0.05 · Mean difference (final values): -3693.2
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = 0.05 · Mean difference (final values): -7548.05
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Mean difference (final values): -3854.86
SecondaryGlucose AUC (Post-insulin)

Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Reported as:
Mean · (mg/dl)*minutes
Glucose AUC (Post-insulin)
(mg/dl)*minutesG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucose AUC (Post-insulin)2263.2 ± 717.12408.1 ± 718.43928.5 ± 703.4
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = >0.05 · Mean difference (final values): -144.9
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = <0.05 · Mean difference (final values): -1665.32
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = >0.05 · Mean difference (final values): -1520.39
SecondaryGlucose Tmax (Fasting)

Pharmacodynamic parameter: Time to reach maximum concentration of glucose

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection
Reported as:
Mean · minutes
Glucose Tmax (Fasting)
minutesG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucose Tmax (Fasting)81.5 ± 10.280.7 ± 10.267.8 ± 10.3
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = >0.05 · Point estimate ratio: 0.41Geometric means
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = >0.05 · Point estimate ratio: 0.43Geometric means
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = >0.05 · Point estimate ratio: 1.05Geometric means
SecondaryGlucose Tmax (Post-insulin)

Pharmacodynamic parameter: Time to reach maximum concentration of glucose

Time frame:
Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection
Reported as:
Mean · minutes
Glucose Tmax (Post-insulin)
minutesG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
Glucose Tmax (Post-insulin)53.5 ± 7.169.5 ± 7.157.4 ± 6.9
Statistical analysis
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 150 ug · Mixed Models Analysis · p = >0.05 · Point estimate ratio: 0.23Geometric means
  • G-Pen Mini™ (Glucagon Injection) 75 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Mixed Models Analysis · p = >0.05 · Point estimate ratio: 0.73Geometric means
  • G-Pen Mini™ (Glucagon Injection) 150 ug vs G-Pen Mini™ (Glucagon Injection) 300 ug · Regression, Linear · p = >0.05 · Point estimate ratio: 3.23Geometric means

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
G-Pen Mini™ (Glucagon Injection) 75 ug—0/12 (0%)10/12 (83.3%)
G-Pen Mini™ (Glucagon Injection) 150 ug—0/12 (0%)11/12 (91.7%)
G-Pen Mini™ (Glucagon Injection) 300 ug—0/12 (0%)11/12 (91.7%)
Most frequent other events
Showing 10 of 15
Most frequent other events
EventG-Pen Mini™ (Glucagon Injection) 75 ugG-Pen Mini™ (Glucagon Injection) 150 ugG-Pen Mini™ (Glucagon Injection) 300 ug
paresthesiaSkin and subcutaneous tissue disorders8/128/129/12
erythemaSkin and subcutaneous tissue disorders6/127/126/12
edemaSkin and subcutaneous tissue disorders2/125/124/12
nauseaGastrointestinal disorders0/120/124/12
painSkin and subcutaneous tissue disorders2/122/123/12
hypoesthesiaSkin and subcutaneous tissue disorders2/120/121/12
hypoglycemiaInjury, poisoning and procedural complications2/122/121/12
blurred visionEye disorders1/121/120/12
noduleSkin and subcutaneous tissue disorders0/120/121/12
bruisingSkin and subcutaneous tissue disorders0/120/121/12

Baseline characteristics

All randomized subjects who received at least one dose of study drug

Age, Categorical
Age, Categorical(Participants)Total Study Group
<=18 years1
Between 18 and 65 years11
>=65 years0
Age, Continuous
Age, Continuous(years)Total Study Group
Mean26.4 ± 9.1
Sex: Female, Male
Sex: Female, Male(Participants)Total Study Group
Female8
Male4
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Total Study Group
Hispanic or Latino0
Not Hispanic or Latino12
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Total Study Group
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White12
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Total Study Group
United States12
HbA1c
HbA1c(percent)Total Study Group
Mean7.7 ± 0.48
Body Weight
Body Weight(kg)Total Study Group
Mean73.6 ± 12.08

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Baylor College of Medicine, Children's Nutritional Research Center, Texas Children's Hospital
    Houston, Texas 77030, United States
09

References and documents

Publications

  • Haymond MW, Redondo MJ, McKay S, Cummins MJ, Newswanger B, Kinzell J, Prestrelski S. Nonaqueous, Mini-Dose Glucagon for Treatment of Mild Hypoglycemia in Adults With Type 1 Diabetes: A Dose-Seeking Study. Diabetes Care. 2016 Mar;39(3):465-8. doi: 10.2337/dc15-2124. Epub 2016 Feb 9. PubMed 26861921 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02081014
Lead sponsor
Xeris Pharmaceuticals
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emissary International LLC
Responsible party
Sponsor
First posted
Mar 7, 2014
Start date
Mar 2014
Primary completion
Nov 2014
Completion
Nov 2014
Results posted
May 16, 2016
Last update
Apr 5, 2018

Study contacts

Morey W Haymond, MD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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