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

Primary Purpose

Hypoglycemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Novo Nordisk GlucaGen®

G-Pump™ (glucagon infusion)

About this trial

This is an interventional treatment trial for Hypoglycemia focused on measuring Hypoglycemia, Glucagon, Artificial Pancreas

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

G-Pump™ (glucagon infusion)

Novo Nordisk GlucaGen®

Arm Description

G-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Novo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Outcomes

Primary Outcome Measures

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

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)

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 Outcome Measures

Glucagon Cmax

Maximum plasma concentration of glucagon

Glucose Cmax

Maximum plasma concentration of glucose

Glucagon Tmax

Time to maximum plasma concentration of glucagon

Glucose Tmax

Time to maximum plasma concentration of glucose

Glucagon AUC

Area under the plasma concentration time curve for glucagon

Glucose AUC

Area under the plasma concentration time curve for glucose

Infusion Site Discomfort Score at 10 Minutes

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

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.

Full Information

NCT ID

NCT02081001

First Posted

March 4, 2014

Last Updated

March 10, 2018

Sponsor

Xeris Pharmaceuticals

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emissary International LLC

1. Study Identification

Unique Protocol Identification Number

NCT02081001

Brief Title

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

Official Title

Comparison of Pharmacokinetic and Pharmacodynamic Profiles of G-Pump™ (Glucagon Infusion) vs. GlucaGen® Delivered Subcutaneously to Subjects With Type 1 Diabetes (T1DM)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xeris Pharmaceuticals

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emissary International LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoglycemia

Keywords

Hypoglycemia, Glucagon, Artificial Pancreas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

G-Pump™ (glucagon infusion)

Arm Type

Experimental

Arm Description

G-Pump™ (glucagon infusion); single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Arm Title

Novo Nordisk GlucaGen®

Arm Type

Active Comparator

Arm Description

Novo Nordisk GlucaGen®; single subcutaneous infusion doses 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Intervention Type

Drug

Intervention Name(s)

Novo Nordisk GlucaGen®

Intervention Description

single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Intervention Type

Drug

Intervention Name(s)

G-Pump™ (glucagon infusion)

Intervention Description

single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg

Primary Outcome Measure Information:

Title

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

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.

Time Frame

0 to 150 minutes post-dosing

Title

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

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.

Time Frame

0 to 150 minutes post-dosing

Secondary Outcome Measure Information:

Title

Glucagon Cmax

Description

Maximum plasma concentration of glucagon

Time Frame