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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Emissary International LLC
Information provided by (Responsible Party):
Xeris Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01972152
First received: October 18, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Hypoglycemia
Drug: G-Pen(TM) 1 mg
Drug: Lilly Glucagon(TM) 1 mg
Drug: G-Pen(TM) 0.5 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A RANDOMIZED, PHASE 2, DOUBLE-BLIND, 3-WAY CROSSOVER STUDY WITH G-PEN™ (GLUCAGON INJECTION) TO EVALUATE SAFETY, TOLERABILITY AND COMPARATIVE PHARMACOKINETICS AND PHARMACODYNAMICS TO LILLY GLUCAGON™ (GLUCAGON FOR INJECTION [rDNA ORIGIN]) IN HEALTHY VOLUNTEERS

Resource links provided by NLM:


Further study details as provided by Xeris Pharmaceuticals:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of G-Pen™ (glucagon injection) 1mg [ Time Frame: From first dose until follow-up visit, an expected average time period of 3 weeks per subject. ] [ Designated as safety issue: Yes ]
    Safety-related parameters include: assessment of 12-lead ECGs, vital signs, AEs as well as serious adverse events (SAEs), body weight and laboratory tests.


Secondary Outcome Measures:
  • To compare the pharmacokinetics of G-Pen™ (glucagon injection) 1mg [test] administered as 0.5 mg and 1 mg injections, versus Lilly Glucagon™ (glucagon for injection [rDNA origin]) 1 mg (reference). [ Time Frame: Approximately 15 minutes before each injection until 4 hours post-injection. ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters include AUC0-inf, Cmax, CL, Tmax, T½ el, and Vext.

  • To evaluate the glucodynamics (efficacy) of G-Pen™ (glucagon injection) 1mg. [ Time Frame: Approximately 15 minutes before each injection until 4 hours post-injection. ] [ Designated as safety issue: No ]
    Pharmacodynamic parameters include BGmax, TBGmax, AUC0-rtb, AUCex, MAE, and TBGex


Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-Pen(TM) 1 mg
G-Pen(TM) (glucagon injection), single 1 mg SC injection
Drug: G-Pen(TM) 1 mg Drug: Lilly Glucagon(TM) 1 mg Drug: G-Pen(TM) 0.5 mg
Experimental: G-Pen(TM) 0.5 mg
G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
Drug: G-Pen(TM) 1 mg Drug: Lilly Glucagon(TM) 1 mg Drug: G-Pen(TM) 0.5 mg
Active Comparator: Lilly Glucagon(TM) 1 mg
Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
Drug: G-Pen(TM) 1 mg Drug: Lilly Glucagon(TM) 1 mg Drug: G-Pen(TM) 0.5 mg

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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 SBP <90 or >140 mm Hg, and 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 ULN
    • AST/SGOT or 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972152

Locations
United States, Texas
Texas Diabetes Institute, University Health System
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
Xeris Pharmaceuticals
Emissary International LLC
Investigators
Principal Investigator: Ralph A DeFronzo, MD Texas Diabetes Institute, University Health System
  More Information

No publications provided

Responsible Party: Xeris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01972152     History of Changes
Other Study ID Numbers: XSGP-201, 2R44DK085809-02
Study First Received: October 18, 2013
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Xeris Pharmaceuticals:
Hypoglycemia
Glucagon

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins

ClinicalTrials.gov processed this record on September 16, 2014