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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia

NCTNCT01972152 (opens ClinicalTrials.gov in a new tab)Other idXSGP-201Other id2R44DK085809-02

Overview

Status
Completed
Phase
Phase 2
Enrollment
30 participants (actual)
Sponsor
Xeris Pharmaceuticals · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Oct 2013
Primary completion
Feb 2014
Completion
Feb 2014
First posted
30 Oct 2013 (estimated)
Last update posted
3 Feb 2016 (estimated)
Conditions
Hypoglycemia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 2

    Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of G-Pen(TM) (Glucagon Injection) to Treat Severe Hypoglycemia

    NCT01972152

    Oct 2013 to Feb 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.

Interventions

  • G-Pen(TM) 1 mgDrug
  • Lilly Glucagon(TM) 1 mgDrug
  • G-Pen(TM) 0.5 mgDrug

Arms3

  • Experimental

    G-Pen(TM) 1 mg

    G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection

  • Experimental

    G-Pen(TM) 0.5 mg

    G-Pen(TM) (glucagon injection), single 0.5 mg SC injection

  • Active comparator

    Lilly Glucagon(TM) 1 mg

    Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Serious Adverse Events

    Time frame · From first dose until completion of the post-treatment follow-up visit, up to 6 weeks

    Registry description

    Number of serious adverse events (SAEs) per treatment group

Secondary outcomes(9)
  1. Glucose Area Under the Curve (AUC)

    Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

    Registry description

    Pharmacodynamic parameter: Glucose area under the curve from baseline to 240 minutes post-treatment

  2. Glucose Cmax

    Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

    Registry description

    Pharmacodynamic parameter: Maximum concentration of glucose

  3. Glucose Tmax

    Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

    Registry description

    Pharmacodynamic parameter: Time to Maximum Glucose Concentration

  4. Glucose AUCex

    Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

    Registry description

    Pharmacodynamic parameter: Area Under the Glucose Excursion Curve

  5. Glucose MAE

    Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

    Registry description

    Pharmacodynamic parameter: Maximum absolute glucose excursion from baseline

  6. Glucose Tex

    Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

    Registry description

    Pharmacodynamic parameter: Earliest reported time of MAE, based on within-subject changes from baseline

  7. Glucagon AUC

    Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

    Registry description

    Pharmacokinetic parameter: Glucagon area under the curve from baseline to 240 minutes post-treatment

  8. Glucagon Cmax

    Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

    Registry description

    Pharmacokinetic parameter: Maximum concentration of glucagon

  9. Glucagon Tmax

    Time frame · Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

    Registry description

    Pharmacokinetic parameter: Time to maximum concentration of glucagon

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· From first dose until completion of the post-treatment follow-up visit, up to 6 weeks

Serious Adverse Events

GroupValue (events)
G-Pen(TM) 1 mg0
G-Pen(TM) 0.5 mg0
Lilly Glucagon(TM) 1 mg0
Secondary and other outcome results(7)
Secondary outcomeMean· Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

Glucose Area Under the Curve (AUC)

GroupValue (min*mg/dL)Spread
G-Pen(TM) 1 mg481.164.9
G-Pen(TM) 0.5 mg46747.9
Lilly Glucagon(TM) 1 mg473.572.9
Secondary outcomeMean· Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

Glucose Cmax

GroupValue (mg/dL)Spread
G-Pen(TM) 1 mg148.0424.94
G-Pen(TM) 0.5 mg140.3223.59
Lilly Glucagon(TM) 1 mg154.928.02
Secondary outcomeMean· Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

Glucose Tmax

GroupValue (minutes)Spread
G-Pen(TM) 1 mg48.211.8
G-Pen(TM) 0.5 mg44.511.2
Lilly Glucagon(TM) 1 mg46.520.5
Secondary outcomeMean· Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

Glucose AUCex

GroupValue (min*mg/dL)Spread
G-Pen(TM) 1 mg228.589.1
G-Pen(TM) 0.5 mg197.374.7
Lilly Glucagon(TM) 1 mg223101.5
Secondary outcomeMean· Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

Glucose MAE

GroupValue (mg/dL)Spread
G-Pen(TM) 1 mg50.822
G-Pen(TM) 0.5 mg42.519.8
Lilly Glucagon(TM) 1 mg53.218.8
Secondary outcomeMean· Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

Glucose Tex

GroupValue (minutes)Spread
G-Pen(TM) 1 mg48.211.8
G-Pen(TM) 0.5 mg61.652.3
Lilly Glucagon(TM) 1 mg68.844.4
Secondary outcomeMean· Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection

Glucagon AUC

GroupValue (min*pg/ml)Spread
G-Pen(TM) 1 mg3259.93447.5
G-Pen(TM) 0.5 mg2105.32381.9
Lilly Glucagon(TM) 1 mg4781.72222.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
G-Pen(TM) 1 mgG-Pen(TM) (glucagon injection), single 1 mg SC injection G-Pen(TM) 1 mg Lilly Glucagon(TM) 1 mg G-Pen(TM) 0.5 mg–0 / 2822 / 28
G-Pen(TM) 0.5 mgG-Pen(TM) (glucagon injection), single 0.5 mg SC injection G-Pen(TM) 1 mg Lilly Glucagon(TM) 1 mg G-Pen(TM) 0.5 mg–0 / 2926 / 29
Lilly Glucagon(TM) 1 mgLilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection G-Pen(TM) 1 mg Lilly Glucagon(TM) 1 mg G-Pen(TM) 0.5 mg–0 / 2822 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Healthy male or female subjects between the ages of 18 and 60 years of age, inclusive, at Screening. 2. Women must be of non-childbearing potential as defined by one of the following: * Females who are \>45 and \< 60 years of age at Screening and amenorrheic for at least 2 years * Females who have had a documented hysterectomy and/or bilateral oophorectomy. 3. Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose): * Oral contraceptive * Injectable progesterone * Subdermal implant * Spermicidal foam/gel/film/cream/suppository * Diaphragm with spermicide * Copper or hormonal containing intrauterine device (IUD) * Sterile male partner vasectomized \> 6 month pre-dosing. 4. Male subjects are required to use a condom and one of the methods of contraception in 2. or 3. above starting at Randomization and for the duration of the study. 5. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 6. Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures. Exclusion Criteria: 1. Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease. 2. Mean of triplicate set of seated BP readings at Screening, confirmed by 1 set of triplicate at Screening, if deemed necessary where systolic blood pressure (SBP) \<90 or \>140 mm Hg, and diastolic blood pressure (DBP) \<50 or \>90 mm Hg. 3. 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. 4. Clinically significant ECG abnormalities. 5. Study participants who are pregnant at Screening are not eligible for this study. 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. Allergies to glucagon, glucagon-like products or to any of the excipients in the investigational formulation. 10. Recent (i.e., within three (3) months prior to Screening) administration of glucagon. 11. Any prior cerebrovascular accident or major permanent neurological damage such as aphasia, hemiparesis, or dementia. 12. Peripheral artery disease with uncontrolled claudication 13. Current diagnosis or current clinical evidence of any New York Heart Association classification of heart failure. 14. Subjects with any of the following abnormalities in clinical laboratory tests at Screening, confirmed by a single repeat, if necessary: * Total bilirubin \> 1.5x upper limit of normal (ULN) * aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5x ULN. * Creatinine \> 2.5x ULN. 15. 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. 16. 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. 17. Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening. 18. 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.

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