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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Feasibility Trial Testing the Bionic Pancreas With ZP4207

Short name dasiglucagon

NCTNCT02971228 (opens ClinicalTrials.gov in a new tab)Other idZP4207-16051
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
13 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Nov 2016
Primary completion
24 May 2017
Completion
7 Jun 2017
First posted
22 Nov 2016 (estimated)
Last update posted
23 Mar 2021
Conditions
Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 2

    dasiglucagon

    NCT02971228

    Nov 2016 to 7 Jun 2017

Registry summary

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

The purpose of this study was to determine whether the Bionic Pancreas with ZP4207 (dasiglucagon\*) was feasible to improve glycemic control in adults with type 1 diabetes mellitus. \*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207

Interventions

  • Insulin LisproDrug
  • ZP4207 (dasiglucagon)Drug
  • GlucagonDrug
  • iPhone-based bionic pancreasDevice
  • iLet-based bionic pancreasDevice

Arms4

  • Experimental

    Part 1, Lilly glucagon then ZP4207

    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.

  • Experimental

    Part 1, ZP4207 then Lilly Glucagon

    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.

  • Experimental

    Part 2, Lilly glucagon then ZP4207

    In Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. 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.

  • Experimental

    Part 2, ZP4207 then Lilly Glucagon

    In Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme. 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters

    Time frame · Up to 50 days

    Registry description

    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.

Secondary outcomes(18)

  1. Pain Measured on a Visual Analog Scale (VAS)

    Time frame · 16 hours

    Registry description

    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.

  2. Nausea Measured on a Visual Analog Scale (VAS)

    Time frame · 16 hours

    Registry description

    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.

  3. Glycemic Regulation

    Time frame · 16 hours

    Registry description

    Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor \[CGM\] glucose\<60mg/dL)

  4. Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

    Time frame · 16 hours

    Registry description

    Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.

  5. Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

    Time frame · 16 hours

    Registry description

    Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.

  6. Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data

    Time frame · 16 hours

    Registry description

    Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.

  7. Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured

    Time frame · 16 hours

    Registry description

    Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.

  8. CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM

    Time frame · 16 hours

    Registry description

    Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.

  9. CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download

    Time frame · 16 hours

    Registry description

    Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis.

  10. Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues

    Time frame · 16 hours

    Registry description

    Technical faults in terms of calibration issues were listed by patient.

  11. Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues

    Time frame · 16 hours

    Registry description

    Technical faults related to connectivity issues were listed

  12. Diabetes Treatment Satisfaction Questionnaire - Status

    Time frame · Up to 3 months

    Registry description

    This questionnaire was not assessed as per protocol amendment 7.

  13. Diabetes Treatment Satisfaction Questionnaire - Change

    Time frame · Up to 3 months

    Registry description

    This questionnaire was not assessed as per protocol amendment 7.

  14. T1-Diabetes Distress Scale

    Time frame · Up to 3 months

    Registry description

    This questionnaire was not assessed as per protocol amendment 7.

  15. Problem Areas in Diabetes Survey

    Time frame · Up to 3 months

    Registry description

    This questionnaire was not assessed as per protocol amendment 7.

  16. Hypoglycemia Fear Survey

    Time frame · Up to 3 months

    Registry description

    This questionnaire was not assessed as per protocol amendment 7.

  17. Impact of Daily Diabetes Demands

    Time frame · Up to 3 months

    Registry description

    This questionnaire was not assessed as per protocol amendment 7.

  18. Bionic Pancreas User Opinion Survey

    Time frame · Up to 3 months

    Registry description

    This questionnaire was not assessed as per protocol amendment 7.

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 outcomeCount of participants· Up to 50 days

Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters

GroupValue (Participants)
Part 1, ZP42078
Part 1, Lilly Glucagon12
Secondary and other outcome results(7)
Secondary outcomeMean· 16 hours

Pain Measured on a Visual Analog Scale (VAS)

GroupValue (cm)Spread
Part 1, ZP42070.000.00
Part 1, Lilly Glucagon0.010.0029
Secondary outcomeMean· 16 hours

Nausea Measured on a Visual Analog Scale (VAS)

GroupValue (cm)Spread
Part 1, ZP42070.000.00
Part 1, Lilly Glucagon0.000.00
Secondary outcomeMean· 16 hours

Glycemic Regulation

GroupValue (percentage of time points)Spread
Part 1, ZP420712.7817.262
Part 1, Lilly Glucagon17.6014.080
Secondary outcomeMean· 16 hours

Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

GroupValue (Percentage of treatment delivered)Spread
Part 1, ZP420796.734.021
Part 1, Lilly Glucagon97.012.851
Secondary outcomeMean· 16 hours

Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

GroupValue (Percentage of treatment delivered)Spread
Part 1, ZP420798.361.114
Part 1, Lilly Glucagon97.732.051
Secondary outcomeMean· 16 hours

Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data

GroupValue (percentage of time functioning nominally)Spread
Part 1, ZP420795.411.846
Part 1, Lilly Glucagon94.263.966
Secondary outcomeMean· 16 hours

Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured

GroupValue (percentage of time functioning nominally)Spread
Part 1, ZP420797.861.125
Part 1, Lilly Glucagon96.313.891

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Part 1, ZP4207In 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.0 / 100 / 108 / 10
Part 1, Lilly GlucagonIn 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.0 / 120 / 1212 / 12

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
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Patients with T1DM for at least 1 year, as defined by the American Diabetes Association 2. Age ≥ 18 years 3. Prescription medication regimen stable for \>1 month (except for medications not expected to affect trial safety or outcome, in the judgment of the investigator) 4. Diabetes managed using an insulin pump for \>=6 months 5. Patients in good health according to age (medical history, physical examination, vital signs, 12-lead electrocardiograms \[ECGs\], laboratory assessments), as judged by the Investigator Exclusion Criteria: 1. Previous exposure to ZP4207 or adverse reaction to glucagon 2. History of liver disease or current abnormal liver function tests (LFTs) 3. Renal failure 4. Anemia 5. History of coronary artery disease or congestive heart failure (class III or IV) 6. History of transient ischemic attack or stroke 7. Seizure disorder 8. Cystic fibrosis, pancreatitis, or any other pancreatic disease besides T1DM 9. Other endocrine disorders 10. Use of oral anti-diabetic medications 11. Electronically powered implants 12. Hypertension (≥160/100 mm Hg despite treatment) 13. Inadequate venous (vein) access as determined by trial nurse or physician at time of screening

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