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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT02081001 (opens ClinicalTrials.gov in a new tab)Other idXSGO-201Other id4R44DK096706-02
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
19 participants (actual)
Sponsor
Xeris Pharmaceuticals · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Mar 2014
Primary completion
Aug 2014
Completion
Sept 2014
First posted
7 Mar 2014 (estimated)
Last update posted
6 Apr 2018
Conditions
Hypoglycemia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 2

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

    NCT02081001

    Mar 2014 to Sept 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Novo Nordisk GlucaGen®Drug
  • G-Pump™ (glucagon infusion)Drug

Arms2

  • 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

  • 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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)

    Time frame · 0 to 150 minutes post-dosing

    Registry description

    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.

  2. Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)

    Time frame · 0 to 150 minutes post-dosing

    Registry description

    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.

Secondary outcomes(8)

  1. Glucagon Cmax

    Time frame · From 0 to 150 minutes post-dosing

    Registry description

    Maximum plasma concentration of glucagon

  2. Glucose Cmax

    Time frame · From 0 to 150 minutes post-dosing

    Registry description

    Maximum plasma concentration of glucose

  3. Glucagon Tmax

    Time frame · From 0 to 150 minutes post-dosing

    Registry description

    Time to maximum plasma concentration of glucagon

  4. Glucose Tmax

    Time frame · From 0 to 150 minutes post-dosing

    Registry description

    Time to maximum plasma concentration of glucose

  5. Glucagon AUC

    Time frame · From 0 to 150 minutes post-dosing

    Registry description

    Area under the plasma concentration time curve for glucagon

  6. Glucose AUC

    Time frame · From 0 to 150 minutes post-dosing

    Registry description

    Area under the plasma concentration time curve for glucose

  7. Infusion Site Discomfort Score at 10 Minutes

    Time frame · At 10 minutes post-dosing

    Registry description

    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.

  8. Infusion Site Discomfort Score at 30 Minutes

    Time frame · At 30 minutes post-dosing

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 0 to 150 minutes post-dosing

Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)

GroupValue (minutes)Spread
0.3 μg/kg G-Pump17.28.76
1.2 μg/kg G-Pump21.918.44
2.0 μg/kg G-Pump21.316.52
0.3μg/kg GlucaGen7.69.45
1.2 μg/kg GlucaGen14.515.36
2.0 μg/kg GlucaGen22.86.51
Primary outcomeMean· 0 to 150 minutes post-dosing

Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)

GroupValue (minutes)Spread
0.3 μg/kg G-Pump12.210.51
1.2 μg/kg G-Pump12.45.07
2.0 μg/kg G-Pump13.94.65
0.3 μg/kg GlucaGen7.63.51
1.2 μg/kg GlucaGen10.54.46
2.0 μg/kg GlucaGen11.03.09
Secondary and other outcome results(6)
Secondary outcomeMean· From 0 to 150 minutes post-dosing

Glucagon Cmax

GroupValue (pg/dl)Spread
0.3 μg/kg G-Pump168.157.66
1.2 μg/kg G-Pump328.2127.9
2.0 μg/kg G-Pump440.6310.9
0.3 μg/kg GlucaGen140.253.69
1.2 μg/kg GlucaGen229.3161.6
2.0 μg/kg GlucaGen446.9220.4
Secondary outcomeMean· From 0 to 150 minutes post-dosing

Glucose Cmax

GroupValue (mg/dl)Spread
0.3 μg/kg G-Pump177.643.1
1.2 μg/kg G-Pump198.849.37
2.0 μg/kg G-Pump212.657.18
0.3 μg/kg GlucaGen162.051.69
1.2 μg/kg GlucaGen183.366.15
2.0 μg/kg GlucaGen200.663.81
Secondary outcomeMean· From 0 to 150 minutes post-dosing

Glucagon Tmax

GroupValue (minutes)Spread
0.3 μg/kg G-Pump24.523.42
1.2 μg/kg G-Pump27.312.93
2.0 μg/kg G-Pump31.915.93
0.3 μg/kg GlucaGen23.310.71
1.2 μg/kg GlucaGen23.96.31
2.0 μg/kg GlucaGen23.98.74
Secondary outcomeMean· From 0 to 150 minutes post-dosing

Glucose Tmax

GroupValue (minutes)Spread
0.3 μg/kg G-Pump38.229.62
1.2 μg/kg G-Pump49.541.79
2.0 μg/kg G-Pump49.440.59
0.3 μg/kg GlucaGen25.928.38
1.2 μg/kg GlucaGen31.234.75
2.0 μg/kg GlucaGen52.820.21
Secondary outcomeMean· From 0 to 150 minutes post-dosing

Glucagon AUC

GroupValue ((pg/dl)*minutes)Spread
0.3 μg/kg G-Pump121043944
1.2 μg/kg G-Pump211776139
2.0 μg/kg G-Pump2759514530
0.3 μg/kg GlucaGen110703032
1.2 μg/kg GlucaGen157817874
2.0 μg/kg GlucaGen2735510757
Secondary outcomeMean· From 0 to 150 minutes post-dosing

Glucose AUC

GroupValue ((mg/dl)*minutes)Spread
0.3 μg/kg G-Pump222967998
1.2 μg/kg G-Pump262517110
2.0 μg/kg G-Pump273608190
0.3 μg/kg GlucaGen210057931
1.2 μg/kg GlucaGen240799348
2.0 μg/kg GlucaGen258458624

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
G-Pump™ (Glucagon Infusion)G-Pump™ (glucagon infusion); single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg delivered via infusion pump–0 / 1916 / 19
Novo Nordisk GlucaGen®Novo Nordisk GlucaGen®; single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg delivered by infusion pump–0 / 1812 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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