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

NCT01972152 | Completed Phase 2 Results

• 2 other identifiers: XSGP-2012R44DK085809-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoglycemia

Keywords

Hypoglycemia; Glucagon

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events

  Number of serious adverse events (SAEs) per treatment group

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

Secondary Outcomes (9)

• Glucose Area Under the Curve (AUC)

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

• Glucose Cmax

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

• Glucose Tmax

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

• Glucose AUCex

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

• Glucose MAE

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

Study Arms (3)

G-Pen(TM) 1 mg

EXPERIMENTAL

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

Drug: G-Pen(TM) 1 mg; Drug: Lilly Glucagon(TM) 1 mg; Drug: G-Pen(TM) 0.5 mg

G-Pen(TM) 0.5 mg

EXPERIMENTAL

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

Lilly Glucagon(TM) 1 mg

ACTIVE COMPARATOR

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

Interventions

G-Pen(TM) 1 mg DRUG

G-Pen(TM) 0.5 mg; G-Pen(TM) 1 mg; Lilly Glucagon(TM) 1 mg

Lilly Glucagon(TM) 1 mg DRUG

G-Pen(TM) 0.5 mg; G-Pen(TM) 1 mg; Lilly Glucagon(TM) 1 mg

G-Pen(TM) 0.5 mg DRUG

G-Pen(TM) 0.5 mg; G-Pen(TM) 1 mg; Lilly Glucagon(TM) 1 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects between the ages of 18 and 60 years of age, inclusive, at Screening.
• 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.
• 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.
• 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.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.

You may not qualify if:

• 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.
• 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.
• 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.
• Clinically significant ECG abnormalities.
• Study participants who are pregnant at Screening are not eligible for this study.
• Breast feeding must be discontinued if a subject wishes to participate in this study.
• Positive test for hepatitis B, hepatitis C, or HIV found at Screening.
• Positive urine drug test for illicit drugs at Screening.
• Allergies to glucagon, glucagon-like products or to any of the excipients in the investigational formulation.
• Recent (i.e., within three (3) months prior to Screening) administration of glucagon.
• Any prior cerebrovascular accident or major permanent neurological damage such as aphasia, hemiparesis, or dementia.
• Peripheral artery disease with uncontrolled claudication
• Current diagnosis or current clinical evidence of any New York Heart Association classification of heart failure.
• 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)

Sponsors & Collaborators

• Xeris Pharmaceuticals: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Emissary International LLC: collaborator

Study Sites (1)

Texas Diabetes Institute, University Health System

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Martin J. Cummins, VP, Drug Development
• Organization: Xeris Pharmaceuticals, Inc.

mcummins@xerispharma.com

512-498-2675

Study Officials

• Ralph A DeFronzo, MD

  Texas Diabetes Institute, University Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 30, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 3, 2016
• Results First Posted: February 3, 2016

Record last verified: 2016-01

Locations

US (1)