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PK/PD Study With G-Pump (Glucagon Infusion) in DM1 Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Emissary International LLC
Information provided by (Responsible Party):
Xeris Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02081001
First received: March 4, 2014
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three doses as compared to Novo GlucaGen®, all delivered via an OmniPod® pump to patients with type 1 diabetes (DM1).


Condition Intervention Phase
Hypoglycemia
Drug: Novo Nordisk GlucaGen®
Drug: G-Pump™ (glucagon infusion)
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: COMPARISON OF PHARMACOKINETIC AND PHARMACODYNAMIC PROFILES OF G-PUMP™ (GLUCAGON INFUSION) VS GLUCAGEN® DELIVERED SUBCUTANEOUSLY TO SUBJECTS WITH TYPE 1 DIABETES (DM1)

Resource links provided by NLM:


Further study details as provided by Xeris Pharmaceuticals:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of G-Pump™ (glucagon infusion) [ 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: Vital signs, physical exam, EKG, standard safety laboratory parameters and incidence of adverse events (AEs) as well as serious adverse events (SAEs)

  • To evaluate the efficacy of G-Pump™ (glucagon infusion) [ Time Frame: Approximately 15 minutes before each injection until 3 hours post-injection ] [ Designated as safety issue: No ]
    The onset of action will be assessed by the time to reach 50% of the maximum glucose concentration (TGLUCOSE-50%-early) and the speed of absorption will be assessed by the time to reach 50% of maximum glucagon concentration (TGLUCAGON-50%-early)


Secondary Outcome Measures:
  • Pharmacokinetics: [ Time Frame: Approximately 15 minutes before each injection until 3 hours post-injection ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters include: AUCGLUCAGON 0-60, AUCGLUCAGON 0-120, AUCGLUCAGON 0-150, CGLUCAGON max, TGLUCAGON max, TGLUCAGON-50%-late

  • Pharmacodynamic: [ Time Frame: Approximately 15 minutes before each injection until 3 hours post-injection ] [ Designated as safety issue: No ]
    AUCGLUCOSE 0-60, AUCGLUCOSE 0-120, AUCGLUCOSE 0-150, Glumax, TGLUCOSE max, TGLUCOSE-50%-late

  • Local Tolerability [ Time Frame: From 10 minutes post-injection until 3 hours post-injection ] [ Designated as safety issue: Yes ]
    Infusion site discomfort as assessed using a 100 mm Visual Analog Scale (VAS) Infusion site discomfort assessed using a categorical (ordinal) infusion site discomfort verbal rating scale Erythema and or edema formation at site of infusion assessed using the Draize scale


Estimated Enrollment: 18
Study Start Date: March 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-Pump™ (glucagon infusion)
G-Pump™ (glucagon infusion); single subcutaneous infusion of each of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg
Drug: Novo Nordisk GlucaGen®
single subcutaneous infusion of each of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg
Drug: G-Pump™ (glucagon infusion)
single subcutaneous infusion of each of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg
Active Comparator: Novo Nordisk GlucaGen®
Novo Nordisk GlucaGen®; single subcutaneous infusion of each of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg
Drug: Novo Nordisk GlucaGen®
single subcutaneous infusion of each of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg
Drug: G-Pump™ (glucagon infusion)
single subcutaneous infusion of each of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females diagnosed with type 1 diabetes mellitus for at least 24 months
  • Current usage of subcutaneous insulin pump treatment
  • Age 18-65 years
  • C-peptide level < 0.5 ng/ml
  • Willingness to follow all study procedures, including attending all clinic visits
  • Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities

Exclusion Criteria:

  • Pregnant and/ or Lactating: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study.
  • HbA1c >9.0%
  • Renal insufficiency (serum creatinine of 1.2 mg/dL or greater)
  • Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less than 3.0 g/dL; or serum bilirubin of over 2.0.
  • Hematocrit of less than or equal to 34%
  • Congestive heart failure, NYHA class II, III or IV
  • History of Coronary artery disease
  • Active foot ulceration
  • History of a cerebrovascular accident
  • Active alcohol abuse or substance abuse
  • Active malignancy, except basal cell or squamous cell skin cancers
  • Major surgical operation within 30 days prior to screening
  • Seizure disorder
  • Current administration of oral or parenteral corticosteroids
  • Use of an investigational drug within 30 days prior to screening
  • Bleeding disorder, treatment with warfarin, or platelet count below 50,000
  • Proliferative or severe non-proliferative retinopathy
  • Gastroparesis
  • Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease)
  • Insulinoma
  • Allergies to glucagon or glucagon-like products, or any history of significant hypersensitivity to glucagon or any related products.
  • Glycogen storage disease
  • Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen
  • Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening.
  • Any reason the principal investigator deems exclusionary
  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: NCT02081001

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Xeris Pharmaceuticals
Emissary International LLC
Investigators
Principal Investigator: Jessica Castle, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Xeris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02081001     History of Changes
Other Study ID Numbers: XSGO-201, 4R44DK096706-02
Study First Received: March 4, 2014
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Xeris Pharmaceuticals:
Hypoglycemia
Glucagon
Artificial Pancreas

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

ClinicalTrials.gov processed this record on November 20, 2014