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PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients

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ClinicalTrials.gov Identifier: NCT02081001
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : August 1, 2016
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Emissary International LLC
Information provided by (Responsible Party):
Xeris Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE March 7, 2014
Results First Submitted Date  ICMJE May 13, 2016
Results First Posted Date  ICMJE August 1, 2016
Last Update Posted Date April 6, 2018
Study Start Date  ICMJE March 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
  • Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early) [ Time Frame: 0 to 150 minutes post-dosing ]
    The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.
  • Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early) [ Time Frame: 0 to 150 minutes post-dosing ]
    The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • 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. ]
    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 ]
    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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
  • Glucagon Cmax [ Time Frame: From 0 to 150 minutes post-dosing ]
    Maximum plasma concentration of glucagon
  • Glucose Cmax [ Time Frame: From 0 to 150 minutes post-dosing ]
    Maximum plasma concentration of glucose
  • Glucagon Tmax [ Time Frame: From 0 to 150 minutes post-dosing ]
    Time to maximum plasma concentration of glucagon
  • Glucose Tmax [ Time Frame: From 0 to 150 minutes post-dosing ]
    Time to maximum plasma concentration of glucose
  • Glucagon AUC [ Time Frame: From 0 to 150 minutes post-dosing ]
    Area under the plasma concentration time curve for glucagon
  • Glucose AUC [ Time Frame: From 0 to 150 minutes post-dosing ]
    Area under the plasma concentration time curve for glucose
  • Infusion Site Discomfort Score at 10 Minutes [ Time Frame: At 10 minutes post-dosing ]
    Infusion site discomfort was assessed by the subjects using a 100 mm Visual Analog Scale (VAS) questionnaire at 10 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.
  • Infusion Site Discomfort Score at 30 Minutes [ Time Frame: At 30 minutes post-dosing ]
    Infusion site discomfort was assessed by the subject using a 100 mm Visual Analog Scale (VAS) questionnaire at 30 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • Pharmacokinetics: [ Time Frame: Approximately 15 minutes before each injection until 3 hours post-injection ]
    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 ]
    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 ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients
Official Title  ICMJE Comparison of Pharmacokinetic and Pharmacodynamic Profiles of G-Pump™ (Glucagon Infusion) vs. GlucaGen® Delivered Subcutaneously to Subjects With Type 1 Diabetes (T1DM)
Brief Summary The purpose of the study is to assess the safety, speed of absorption, and onset of action of G-Pump™ (glucagon infusion) at three subcutaneous doses as compared to Novo GlucaGen®, all delivered via an OmniPod® infusion pump to patients with type 1 diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypoglycemia
Intervention  ICMJE
  • Drug: Novo Nordisk GlucaGen®
    single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
  • Drug: G-Pump™ (glucagon infusion)
    single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
Study Arms  ICMJE
  • Experimental: G-Pump™ (glucagon infusion)
    G-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
    Interventions:
    • Drug: Novo Nordisk GlucaGen®
    • Drug: G-Pump™ (glucagon infusion)
  • Active Comparator: Novo Nordisk GlucaGen®
    Novo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
    Interventions:
    • Drug: Novo Nordisk GlucaGen®
    • Drug: G-Pump™ (glucagon infusion)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2015)
19
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2014)
18
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 >10.0%
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02081001
Other Study ID Numbers  ICMJE XSGO-201
4R44DK096706-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xeris Pharmaceuticals
Study Sponsor  ICMJE Xeris Pharmaceuticals
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Emissary International LLC
Investigators  ICMJE
Principal Investigator: Jessica Castle, MD Oregon Health and Science University
PRS Account Xeris Pharmaceuticals
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP