Trial Outcomes & Findings for Feasibility Trial Testing the Bionic Pancreas With ZP4207 (NCT NCT02971228)
NCT ID: NCT02971228
Last Updated: 2021-03-23
Results Overview
Safety and tolerability of ZP4207 in the BP using either the iPhone or the iLet platform, as measured by adverse events (AEs), local tolerability of infusion site reactions, and clinical laboratory parameters. See adverse events section for results on AEs by system organ class and preferred term. Clinical laboratory parameters in terms of overall 'investigations' AEs and abnormal hematology parameters that did not resolve by the follow-up visit are presented below. LLN = lower limit of the normal range. Investigations and vital signs AEs by preferred term are presented in the AE section. Participants with infusion site pain and nausea measured by visual analog scales (VAS) are presented below; mean values are presented under secondary outcomes. For the VAS, individuals marked on a 10-cm line corresponding to the amount of pain or nausea being experienced, with low scores (cm) indicating no feelings of pain or nausea and high scores (cm) indicating high feelings of pain or nausea.
COMPLETED
PHASE2
13 participants
Up to 50 days
2021-03-23
Participant Flow
In Part 1, it was planned to enrol 10 patients in two 1-day treatment arms in random order (iPhone-based bionic pancreas using ZP4207 or Lilly Glucagon) according to a pre-generated randomization scheme. The trial had a crossover design. In all, 19 patients were screened and 13 were randomized, but 1 patient withdrew before treatment. Thus, 12 patients were randomized and treated.
Part 2 was designed to enroll up to 10 new patients in two 1-day treatment arms in random order (iLet using ZP4207 or Lilly Glucagon). However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted.
Participant milestones
| Measure |
Part 1 Lilly Glucagon or ZP4207
1 patient was enrolled but withdrew prior to treatment with either trial drug
|
Part 1, Lilly Glucagon Then ZP4207
7 patients received Lilly Glucagon then ZP4207 in this treatment sequence (2 withdrew before receiving ZP4207). Insulin Lispro was also administered in both treatment arms.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, ZP4207 Then Lilly Glucagon
5 patients received ZP4207 then Lilly Glucagon in this treatment sequence. Insulin Lispro was also administered in both treatment arms.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration.
iPhone-based bionic pancreas: An experimental device.
|
Part 2, ZP4207 Then Lilly Glucagon
Part 2 of the trial was not conducted - see above.
|
Part 2, Lilly Glucagon Then ZP4207
Part 2 of the trial was not conducted - see above.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
7
|
5
|
0
|
0
|
|
Overall Study
Randomized and Treated
|
0
|
7
|
5
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
5
|
5
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1 Lilly Glucagon or ZP4207
1 patient was enrolled but withdrew prior to treatment with either trial drug
|
Part 1, Lilly Glucagon Then ZP4207
7 patients received Lilly Glucagon then ZP4207 in this treatment sequence (2 withdrew before receiving ZP4207). Insulin Lispro was also administered in both treatment arms.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, ZP4207 Then Lilly Glucagon
5 patients received ZP4207 then Lilly Glucagon in this treatment sequence. Insulin Lispro was also administered in both treatment arms.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration.
iPhone-based bionic pancreas: An experimental device.
|
Part 2, ZP4207 Then Lilly Glucagon
Part 2 of the trial was not conducted - see above.
|
Part 2, Lilly Glucagon Then ZP4207
Part 2 of the trial was not conducted - see above.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Logistical challenges
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Feasibility Trial Testing the Bionic Pancreas With ZP4207
Baseline characteristics by cohort
| Measure |
Part 1, All Participants
n=12 Participants
In Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. Note: 13 patients were enrolled and 1 patient withdrew prior to treatment with either trial drug; thus, 12 patients were randomized and treated.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|
|
Age, Continuous
|
42.5 Years
STANDARD_DEVIATION 18.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
Body weight
|
80.28 kg
STANDARD_DEVIATION 18.357 • n=5 Participants
|
|
BMI
|
27.36 kg/m^2
STANDARD_DEVIATION 5.301 • n=5 Participants
|
|
Diabetes duration
|
28.2 years
STANDARD_DEVIATION 14.72 • n=5 Participants
|
|
HbA1c
|
7.18 %
STANDARD_DEVIATION 1.462 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 50 daysPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
Safety and tolerability of ZP4207 in the BP using either the iPhone or the iLet platform, as measured by adverse events (AEs), local tolerability of infusion site reactions, and clinical laboratory parameters. See adverse events section for results on AEs by system organ class and preferred term. Clinical laboratory parameters in terms of overall 'investigations' AEs and abnormal hematology parameters that did not resolve by the follow-up visit are presented below. LLN = lower limit of the normal range. Investigations and vital signs AEs by preferred term are presented in the AE section. Participants with infusion site pain and nausea measured by visual analog scales (VAS) are presented below; mean values are presented under secondary outcomes. For the VAS, individuals marked on a 10-cm line corresponding to the amount of pain or nausea being experienced, with low scores (cm) indicating no feelings of pain or nausea and high scores (cm) indicating high feelings of pain or nausea.
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with AEs
|
8 Participants
|
12 Participants
|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with antibodies
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with edema infusion site reactions
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with erythema infusion site reactions
|
0 Participants
|
0 Participants
|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with investigations AEs
|
2 Participants
|
2 Participants
|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with erythrocytes <LLN
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with hematocrit <LLN
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with hemoglobin <LLN
|
0 Participants
|
2 Participants
|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with lymphocytes <LLN
|
0 Participants
|
1 Participants
|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with infusion site pain (VAS)
|
0 Participants
|
2 Participants
|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with nausea (VAS)
|
4 Participants
|
2 Participants
|
|
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
Participants with vascular disorders
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 16 hoursPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
The VAS scale was used to measure pain at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of pain. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of pain being experienced, with low scores (cm) indicating no feelings of pain and high scores (cm) indicating high feelings of pain. Actual values are shown. The maximum value in the Lilly glucagon group was recorded at hour 3.
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
Pain Measured on a Visual Analog Scale (VAS)
Baseline
|
0.00 cm
Standard Deviation 0.00
|
0.01 cm
Standard Deviation 0.0029
|
|
Pain Measured on a Visual Analog Scale (VAS)
Hour 1
|
0.00 cm
Standard Deviation 0.00
|
0.00 cm
Standard Deviation 0.00
|
|
Pain Measured on a Visual Analog Scale (VAS)
Hour 2
|
0.00 cm
Standard Deviation 0.00
|
0.00 cm
Standard Deviation 0.00
|
|
Pain Measured on a Visual Analog Scale (VAS)
Hour 3
|
0.00 cm
Standard Deviation 0.00
|
0.06 cm
Standard Deviation 0.202
|
|
Pain Measured on a Visual Analog Scale (VAS)
Hour 4
|
0.00 cm
Standard Deviation 0.00
|
0.00 cm
Standard Deviation 0.00
|
|
Pain Measured on a Visual Analog Scale (VAS)
Hour 5
|
0.00 cm
Standard Deviation 0.00
|
0.00 cm
Standard Deviation 0.00
|
|
Pain Measured on a Visual Analog Scale (VAS)
Hour 6
|
0.00 cm
Standard Deviation 0.00
|
0.00 cm
Standard Deviation 0.00
|
|
Pain Measured on a Visual Analog Scale (VAS)
Hour 7
|
0.00 cm
Standard Deviation 0.00
|
0.02 cm
Standard Deviation 0.058
|
|
Pain Measured on a Visual Analog Scale (VAS)
Visit end (16 hours)
|
0.00 cm
Standard Deviation 0.00
|
0.00 cm
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 16 hoursPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
The VAS scale was used to measure nausea at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of nausea. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of nausea being experienced, with low scores (cm) indicating no feelings of nausea and high scores (cm) indicating high feelings of nausea. Actual values are shown. The maximum values in both groups were recorded at hour 6, the start of the exercise period.
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
Nausea Measured on a Visual Analog Scale (VAS)
Baseline
|
0.00 cm
Standard Deviation 0.00
|
0.00 cm
Standard Deviation 0.00
|
|
Nausea Measured on a Visual Analog Scale (VAS)
Hour 1
|
0.12 cm
Standard Deviation 0.379
|
0.00 cm
Standard Deviation 0.00
|
|
Nausea Measured on a Visual Analog Scale (VAS)
Hour 2
|
0.00 cm
Standard Deviation 0.00
|
0.00 cm
Standard Deviation 0.00
|
|
Nausea Measured on a Visual Analog Scale (VAS)
Hour 3
|
0.11 cm
Standard Deviation 0.348
|
0.04 cm
Standard Deviation 0.144
|
|
Nausea Measured on a Visual Analog Scale (VAS)
Hour 4
|
0.00 cm
Standard Deviation 0.00
|
0.00 cm
Standard Deviation 0.00
|
|
Nausea Measured on a Visual Analog Scale (VAS)
Hour 5
|
0.02 cm
Standard Deviation 0.063
|
0.09 cm
Standard Deviation 0.215
|
|
Nausea Measured on a Visual Analog Scale (VAS)
Hour 6
|
0.29 cm
Standard Deviation 0.917
|
0.18 cm
Standard Deviation 0.522
|
|
Nausea Measured on a Visual Analog Scale (VAS)
Hour 7
|
0.00 cm
Standard Deviation 0.00
|
0.00 cm
Standard Deviation 0.00
|
|
Nausea Measured on a Visual Analog Scale (VAS)
Visit end (16 hours)
|
0.11 cm
Standard Deviation 0.348
|
0.00 cm
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 16 hoursPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor \[CGM\] glucose\<60mg/dL)
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
Glycemic Regulation
|
12.78 percentage of time points
Standard Deviation 17.262
|
17.60 percentage of time points
Standard Deviation 14.080
|
SECONDARY outcome
Timeframe: 16 hoursPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
|
96.73 Percentage of treatment delivered
Standard Deviation 4.021
|
97.01 Percentage of treatment delivered
Standard Deviation 2.851
|
SECONDARY outcome
Timeframe: 16 hoursPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
|
98.36 Percentage of treatment delivered
Standard Deviation 1.114
|
97.73 Percentage of treatment delivered
Standard Deviation 2.051
|
SECONDARY outcome
Timeframe: 16 hoursPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data
|
95.41 percentage of time functioning nominally
Standard Deviation 1.846
|
94.26 percentage of time functioning nominally
Standard Deviation 3.966
|
SECONDARY outcome
Timeframe: 16 hoursPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured
|
97.86 percentage of time functioning nominally
Standard Deviation 1.125
|
96.31 percentage of time functioning nominally
Standard Deviation 3.891
|
SECONDARY outcome
Timeframe: 16 hoursPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM
|
97.55 percentage of recorded values
Standard Deviation 1.219
|
97.94 percentage of recorded values
Standard Deviation 1.076
|
SECONDARY outcome
Timeframe: 16 hoursPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download
|
12.6 mg/dL
Standard Deviation 4.13
|
12.7 mg/dL
Standard Deviation 5.43
|
SECONDARY outcome
Timeframe: 16 hoursPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
Technical faults in terms of calibration issues were listed by patient.
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 16 hoursPopulation: The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted.
Technical faults related to connectivity issues were listed
Outcome measures
| Measure |
Part 1, ZP4207
n=10 Participants
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 Participants
In Part 1, 12 patients received treatment with Lilly glucagon in the iPhone-based Bionic Pancreas with insulin lispro according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: This questionnaire was not assessed as per protocol amendment 7.
This questionnaire was not assessed as per protocol amendment 7.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: This questionnaire was not assessed as per protocol amendment 7.
This questionnaire was not assessed as per protocol amendment 7.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: This questionnaire was not assessed as per protocol amendment 7.
This questionnaire was not assessed as per protocol amendment 7.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: This questionnaire was not assessed as per protocol amendment 7.
This questionnaire was not assessed as per protocol amendment 7.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: This questionnaire was not assessed as per protocol amendment 7.
This questionnaire was not assessed as per protocol amendment 7.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: This questionnaire was not assessed as per protocol amendment 7.
This questionnaire was not assessed as per protocol amendment 7.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: This questionnaire was not assessed as per protocol amendment 7.
This questionnaire was not assessed as per protocol amendment 7.
Outcome measures
Outcome data not reported
Adverse Events
Part 1, ZP4207
Part 1, Lilly Glucagon
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1, ZP4207
n=10 participants at risk
In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
Part 1, Lilly Glucagon
n=12 participants at risk
In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme.
Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
Glucagon: A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
iPhone-based bionic pancreas: An experimental device.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • Up to 50 days
|
8.3%
1/12 • Number of events 1 • Up to 50 days
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • Number of events 1 • Up to 50 days
|
0.00%
0/12 • Up to 50 days
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • Up to 50 days
|
8.3%
1/12 • Number of events 1 • Up to 50 days
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Number of events 5 • Up to 50 days
|
16.7%
2/12 • Number of events 3 • Up to 50 days
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • Up to 50 days
|
0.00%
0/12 • Up to 50 days
|
|
General disorders
Infusion site pain
|
10.0%
1/10 • Number of events 1 • Up to 50 days
|
16.7%
2/12 • Number of events 5 • Up to 50 days
|
|
General disorders
Asthenia
|
10.0%
1/10 • Number of events 1 • Up to 50 days
|
0.00%
0/12 • Up to 50 days
|
|
Investigations
Neutrophil count increased
|
20.0%
2/10 • Number of events 3 • Up to 50 days
|
8.3%
1/12 • Number of events 1 • Up to 50 days
|
|
Investigations
White blood cell count increased
|
20.0%
2/10 • Number of events 2 • Up to 50 days
|
8.3%
1/12 • Number of events 1 • Up to 50 days
|
|
Investigations
Blood glucose decreased
|
10.0%
1/10 • Number of events 1 • Up to 50 days
|
8.3%
1/12 • Number of events 1 • Up to 50 days
|
|
Investigations
Lymphocyte count increased
|
10.0%
1/10 • Number of events 1 • Up to 50 days
|
0.00%
0/12 • Up to 50 days
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
60.0%
6/10 • Number of events 14 • Up to 50 days
|
75.0%
9/12 • Number of events 20 • Up to 50 days
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • Number of events 1 • Up to 50 days
|
8.3%
1/12 • Number of events 1 • Up to 50 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • Up to 50 days
|
8.3%
1/12 • Number of events 1 • Up to 50 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Up to 50 days
|
8.3%
1/12 • Number of events 1 • Up to 50 days
|
|
Vascular disorders
Orthostatic hypotension
|
10.0%
1/10 • Number of events 1 • Up to 50 days
|
8.3%
1/12 • Number of events 1 • Up to 50 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • Up to 50 days
|
8.3%
1/12 • Number of events 1 • Up to 50 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place