Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Phase 3 Study to Evaluate the Glucose Response of G-Pen (Glucagon Injection) in Pediatric Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091673
• Other study ID #: XSGP-302
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2017
• Est. completion date: September 27, 2017

Study information

• Verified date: November 2018
• Source: Xeris Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes. Subjects will be administered insulin to induce a low normal glycemic state and will then receive an age-appropriate dose of G-Pen (glucagon injection) in a clinical research center (CRC) or comparable setting.

Description:

This is an open-label, Phase 3 sequential efficacy and safety study in pediatric patients ages 2-17 with type 1 diabetes. Patients will complete the screening procedures up to 30 days before dosing to determine eligibility before enrollment to the treatment phase.

The procedure to evaluate the efficacy of G-Pen (glucagon injection) consists of inducing a low normal glycemic state by administration of insulin. Subjects ages 2-11 will then be given a 0.5 mg dose of G-Pen, while subjects ages 12-17 will receive a 1 mg dose of G-Pen. Subjects ages 12-17 will return for a second visit 1-4 weeks later and will receive a 0.5 mg dose of G-Pen when in a low normal glycemic stare. Plasma glucose and glucagon levels will be monitored for 90 and 180 minutes post-dosing, respectively, at all visits.

A follow-up phone call as a safety check will be conducted 3 - 14 days following administration of the final dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 27, 2017
• Est. primary completion date: September 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• diagnosed with T1D for at least 6 months at Screening.

• current usage of daily insulin treatment.

Exclusion Criteria:

• pregnant or nursing

• renal insufficiency

• hepatic synthetic insufficiency

• aspartate or alanine aminotransferase > 3 times the upper limit of normal

• hematocrit less than or equal to 30%

• use of > 2.0 U/kg total insulin dose per day

• inadequate venous access

• current seizure disorder

• history of pheochromocytoma or disorder with increased risk of pheochromocytoma

• history of insulinoma

• history of glycogen storage disease.

• active use of alcohol or drugs of abuse

• administration of glucagon within 14 days of the first treatment visit

• participation in other studies involving an investigational drug or device within 30 days

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Glucagon
0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

Locations

Country	Name	City	State
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	Women & Children's Hospital of Buffalo	Buffalo	New York
United States	University of Florida	Gainesville	Florida
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Yale University	New Haven	Connecticut
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Xeris Pharmaceuticals	The EMMES Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Plasma Glucose	The primary endpoint for this study is an evaluation of change in plasma glucose following treatment with G-Pen, with an emphasis on the increase from baseline to 30 minutes post-dosing.	0-30 minutes
Secondary	Time for Plasma Glucose to Increase by =25 mg/dL	Time for plasma glucose to increase by =25 mg/dL from baseline will be analyzed descriptively for each age cohort.	0-90 minutes
Secondary	Plasma Glucagon Area Under the Curve	Plasma glucagon area under the curve (AUC) for each age cohort will be analyzed descriptively.	0-90 minutes
Secondary	Plasma Glucagon Cmax	Plasma glucagon maximum concentration for each age cohort will be analyzed descriptively.	0-180 minutes
Secondary	Plasma Glucagon Tmax	Plasma glucagon time to maximum concentration for each age cohort will be analyzed descriptively.	0-180 minutes