Trial Outcomes & Findings for PK/PD Study With G-Pump (Glucagon Infusion) in T1DM Patients (NCT NCT02081001)

NCT ID: NCT02081001

Last Updated: 2018-04-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

0 to 150 minutes post-dosing

Results posted on

2018-04-06

Participant Flow

A total of 19 adults ages 18-65 years with type 1 diabetes were recruited over a period of 4 months to receive treatment at a public university hospital.

A total of 30 subjects were screened for study inclusion. The 19 subjects who met all eligibility criteria were randomized and assigned to treatment.

Participant milestones

Participant milestones
Measure	Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.	Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.	Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.	Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.	Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.	Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
Overall Study STARTED	2	1	2	1	3	1	2	1	2	1	2	1
Overall Study COMPLETED	2	1	2	1	2	1	2	1	2	1	2	1
Overall Study NOT COMPLETED	0	0	0	0	1	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.	Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.	Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.	Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.	Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.	Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.	Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
Overall Study Adverse Event	0	0	0	0	1	0	0	0	0	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xeris G-Pump Glucagon First, Followed by GlucaGen n=13 Participants Subjects who received G-Pump (glucagon infusion) at the first treatment visit and GlucaGen at the second treatment visit.	GlucaGen First, Followed by Xeris G-Pump n=6 Participants Subjects who received GlucaGen at the first treatment visit and G-Pump (glucagon infusion) at the second treatment visit.	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.7 years STANDARD_DEVIATION 9.54 • n=5 Participants	32.2 years STANDARD_DEVIATION 8.38 • n=7 Participants	35.3 years STANDARD_DEVIATION 9.21 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	6 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 150 minutes post-dosing

Population: All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.

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.

Outcome measures

Outcome measures
Measure	0.3 μg/kg G-Pump n=14 Participants 0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump	1.2 μg/kg G-Pump n=18 Participants 1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump	2.0 μg/kg G-Pump n=19 Participants 2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump	0.3μg/kg GlucaGen n=11 Participants 0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump	1.2 μg/kg GlucaGen n=16 Participants 1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump	2.0 μg/kg GlucaGen n=16 Participants 2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)	17.2 minutes Standard Deviation 8.76	21.9 minutes Standard Deviation 18.44	21.3 minutes Standard Deviation 16.52	7.6 minutes Standard Deviation 9.45	14.5 minutes Standard Deviation 15.36	22.8 minutes Standard Deviation 6.51

PRIMARY outcome

Timeframe: 0 to 150 minutes post-dosing

Population: All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.

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.