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Trial record 1 of 1 for:    xsgp-304
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G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03738865
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Empiristat, Inc.
Information provided by (Responsible Party):
Xeris Pharmaceuticals

Brief Summary:
This is a multi-center, randomized, controlled, single-blind, two-way crossover efficacy and safety study in subjects with Type 1 diabetes mellitus. The study involves two daytime clinical research center (CRC) visits with random assignment to receive G-Pen glucagon 1 mg during one period and Novo Glucagon 1 mg during the other. Each daytime visit is preceded by an overnight stay in the CRC. In the morning of the inpatient study visit, the subject is brought into a state of severe hypoglycemia through IV administration of regular insulin diluted in normal saline. After a hypoglycemic state with plasma glucose < 54 mg/dL (3 mmol/L) is verified, the subject is administered a dose of G-Pen or Novo Glucagon via subcutaneous injection. Plasma glucose levels are monitored for up to 180 minutes post-dosing, with a value of >70.0 mg/dL (3.89 mmol/L) or an increase of > 20 mg/dL (>1.11 mmol/L) within 30 minutes of glucagon administration indicating a positive response. After 3 hours, the subject is given a meal and discharged when medically stable. After a wash-out period of 7 to 28 days, subjects return to the CRC, and the procedures are repeated with each subject crossed over to the other treatment. A follow-up visit as a safety check is conducted 2-7 days following administration of the final dose of study drug.

Condition or disease Intervention/treatment Phase
Insulin Hypoglycemia Type 1 Diabetes Mellitus Severe Hypoglycemia Drug: G-Pen Drug: Novo Glucagon Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: G-Pen (Glucagon Injection) Compared to GlucaGen® Hypokit® (Glucagon) for Induced Hypoglycemia Rescue in Adults With T1D: A Phase 3 Multi-center, Randomized, Controlled, Single Blind, 2-way Crossover Study to Evaluate Efficacy and Safety
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: G-Pen followed by Novo Glucagon
1 mg G-Pen at the first treatment visit followed by 1 mg Novo Glucagon at the second treatment visit
Drug: G-Pen
1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Other Name: glucagon

Drug: Novo Glucagon
1 mg subcutaneous injection of Novo Glucagon (glucagon injection)
Other Name: Glucagen Hypokit

Active Comparator: Novo Glucagon followed by G-Pen
1 mg Novo Glucagon at the first treatment visit followed by 1 mg G-Pen at the second treatment visit
Drug: G-Pen
1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
Other Name: glucagon

Drug: Novo Glucagon
1 mg subcutaneous injection of Novo Glucagon (glucagon injection)
Other Name: Glucagen Hypokit




Primary Outcome Measures :
  1. Severe Hypoglycemia Rescue [ Time Frame: At 30 minutes following administration of study drug ]
    Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) within 30 minutes after administration of glucagon


Secondary Outcome Measures :
  1. Time to Severe Hypoglycemia Rescue [ Time Frame: At 0-90 minutes following administration of study drug ]
    Mean time (minutes) to an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) after administration of glucagon

  2. Plasma Glucose Response [ Time Frame: At 30 minutes following a decision to administer study drug ]
    Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) within 30 minutes of a decision to dose

  3. Time to Plasma Glucose Response [ Time Frame: At 0-90 minutes following a decision to administer study drug ]
    Mean time (minutes) to an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) after administration of glucagon

  4. Neuroglycopenic Symptom Response [ Time Frame: At 30 minutes following a decision to administer study drug ]
    Number of subjects with relief of neuroglycopenic symptoms within 30 minutes from a decision to dose.

  5. Treatment Response [ Time Frame: At 30 minutes following administration of study drug ]
    Number of subjects with either an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L), an increase in plasma glucose concentration > 20 mg/dL (> 1.11 mmol/L) within 30 minutes after administration of glucagon, or relief of neuroglycopenic symptoms within 30 minutes of a decision to dose

  6. Administration Time [ Time Frame: At 0-10 minutes from a decision to administer study drug ]
    Mean time (minutes) to administer study drug from a decision to dose

  7. Autonomic symptom relief [ Time Frame: At 0-90 minutes following administration of study drug ]
    Mean time (minutes) to initial relief of autonomic symptoms of hypoglycemia from a decision to dose

  8. Autonomic symptom resolution [ Time Frame: At 0-90 minutes following administration of study drug ]
    Mean time (minutes) to complete resolution of autonomic symptoms of hypoglycemia from a decision to dose

  9. Neuroglycopenic symptom relief [ Time Frame: At 0-90 minutes following administration of study drug ]
    Mean time (minutes) to initial relief of neuroglycopenic symptoms of hypoglycemia from a decision to dose

  10. Neuroglycopenic symptom resolution [ Time Frame: At 0-90 minutes following administration of study drug ]
    Mean time (minutes) to complete resolution of neuroglycopenic symptoms of hypoglycemia from a decision to dose

  11. Hypoglycemia resolution [ Time Frame: At 0-90 minutes following administration of study drug ]
    Mean time (minutes) to complete resolution of the overall sensation of hypoglycemia from a decision to dose

  12. Plasma Glucose Maximum Concentration (Cmax) [ Time Frame: At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon ]
    Pharmacodynamic endpoint of plasma glucose Cmax from baseline to 90 minutes following administration of glucagon

  13. Plasma Glucose Time to Maximum Concentration (Tmax) [ Time Frame: At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon ]
    Pharmacodynamic endpoint of plasma glucose Tmax from baseline to 90 minutes following administration of glucagon

  14. Plasma Glucose Area Under the Curve (AUC0-90) [ Time Frame: At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon ]
    Pharmacodynamic endpoint of plasma glucose AUC from baseline to 90 minutes following administration of glucagon

  15. Plasma Glucose Area Under the Curve (AUC0-180) [ Time Frame: At -5, 0, 10, 20, 30, 45, 60, 90, 120 and 180 minutes following administration of glucagon ]
    Pharmacodynamic endpoint of plasma glucose AUC from baseline to 180 minutes following administration of glucagon



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and non-pregnant females diagnosed with type 1 diabetes (T1D) for at least 24 months.
  2. Current usage of daily insulin treatment that includes having an assigned "correction factor" for managing hyperglycemia.
  3. Age 18 to 75 years, inclusive.
  4. Random serum C-peptide concentration < 0.6 ng/mL.
  5. Willingness to follow all study procedures, including attending all clinic visits.
  6. Subject has provided informed consent as evidenced by a signed and dated informed consent form (ICF) completed before any trial-related activities occur.

Exclusion Criteria:

  1. Pregnancy
  2. Glycated hemoglobin (HbA1c) > 10% at Screening.
  3. Body mass index (BMI) > 40 kg/m2.
  4. Renal insufficiency (serum creatinine greater than 3.0 mg/dL) or end-stage renal disease requiring renal replacement therapy.
  5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or greater than 3 times the upper limit of normal.
  6. Hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL.
  7. Hematocrit < 30%.
  8. Blood pressure (BP) readings at Screening where systolic blood pressure (SBP) < 90 or > 150 mm Hg, and diastolic blood pressure (DBP) < 50 or > 100 mm Hg.
  9. Clinically significant electrocardiogram (ECG) abnormalities.
  10. Use of total insulin dose per day > 2 U/kg.
  11. Inadequate venous access.
  12. Congestive heart failure, New York Heart Association (NYHA) class III or IV.
  13. History of myocardial infarction, unstable angina, or revascularization within the past 6 months.
  14. History of a cerebrovascular accident in the past 6 months or with major neurological deficits.
  15. Active malignancy within 5 years from Screening, except basal cell or squamous cell skin cancers. Any history of breast cancer or malignant melanoma will be exclusionary.
  16. Major surgical operation within 30 days prior to Screening.
  17. Current seizure disorder (other than with suspect or documented hypoglycemia).
  18. Current bleeding disorder, treatment with warfarin, or platelet count below 50 × 109 per liter.
  19. History of pheochromocytoma or disorder with increased risk of pheochromocytoma (multiple endocrine neoplasia type 2 (MEN 2), neurofibromatosis, or Von Hippel-Lindau disease).
  20. History of insulinoma.
  21. History of allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products or to any of the excipients (DMSO and trehalose) in the investigational formulation.
  22. History of glycogen storage disease.
  23. Subject tests positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection (hepatitis B surface antigen positive [HBsAg+]) at Screening.
  24. Active substance other than tetrahydrocannabinol (THC) or alcohol abuse (more than 21 drinks per week for male subjects or 14 drinks per week for female subject).
  25. Administration of glucagon within 7 days of Screening.
  26. 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.
  27. Any other reason the Investigator deems exclusionary.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738865


Contacts
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Contact: Martin J Cummins 806-282-2120 mcummins@xerispharma.com
Contact: Khaled Junaidi, MD 312-517-1461 kjunaidi@xerispharma.com

Locations
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United States, California
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: Erica Bingham, RN    925-930-7267    ebingham@diabloclinical.com   
Principal Investigator: Mark Christiansen, MD         
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Contact: Betsy Childs, BSN, RN    404-355-4393 ext 864    bchilds@atlantadiabetes.com   
Principal Investigator: Bruce Bode, MD         
United States, Nevada
PPD-Las Vegas Clinical Research Unit Recruiting
Las Vegas, Nevada, United States, 89113
Contact: Marjorie Hyderkhan    702-963-1580    Marjorie.Hyderkhan@ppdi.com   
Principal Investigator: Samer Nakhle, MD         
United States, Washington
Rainier Research Center Recruiting
Renton, Washington, United States, 98057
Contact: Lisa Aaker    425-251-1720 ext 19    laaker@rainier-research.com   
Principal Investigator: Leslie Klaff, MD, PhD         
Austria
Medizinische Universität Graz-Center for Medical Research Recruiting
Graz, Austria, 8010
Contact: Daniela Schwarzenbacher    43-316-385-82383    daniela.schwarzenbacher@medunigraz.at   
Principal Investigator: Thomas Pieber, PhD         
Canada, Ontario
LMC Diabetes & Endocrinology Recruiting
Toronto, Ontario, Canada, M4G 3E8
Contact: Nichole McKay    41+-645-2929 ext 9225    nichole.mckay@lmcmanna.com   
Principal Investigator: Ronnie Aronson, MD         
Canada, Quebec
AltaSciences Not yet recruiting
Montréal, Quebec, Canada, H3P 3P1
Contact: Sylvie Boily    514-858-6077    sboily@altasciences.com   
Principal Investigator: Eric Sicard, MD         
Germany
Profil Institut für Stoffwechselforschung GmbH Not yet recruiting
Neuss, Germany, 41460
Contact: Andre Feldmann    49 (0) 2131-4018-450    andre.feldmann@profil.com   
Principal Investigator: Oliver Klein, MD         
Institut für Diabetes-Technologie Not yet recruiting
Ulm, Germany, 89081
Contact: Tobias Naser    0731-50-99-00    tobias.naser@idtulm.De   
Principal Investigator: Theodor Rudolf, MD         
Sponsors and Collaborators
Xeris Pharmaceuticals
Empiristat, Inc.

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Responsible Party: Xeris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03738865     History of Changes
Other Study ID Numbers: XSGP-304
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xeris Pharmaceuticals:
glucagon
hypoglycemia

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins