Overview

This trial is active, not recruiting.

Condition hypoglycemia
Treatments g-pen(tm) 1 mg, lilly glucagon(tm) 1 mg, g-pen(tm) 0.5 mg
Phase phase 2
Sponsor Xeris Pharmaceuticals
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date October 2013
End date February 2014
Trial size 30 participants
Trial identifier NCT01972152, 2R44DK085809-02, XSGP-201

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
G-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
(Experimental)
G-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
(Active Comparator)
Lilly 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

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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.
To evaluate the glucodynamics (efficacy) of G-Pen™ (glucagon injection) 1mg.
time frame: Approximately 15 minutes before each injection until 4 hours post-injection.

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

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
Principal investigator Ralph A DeFronzo, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Xeris Pharmaceuticals.