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Completed

NCT Number: NCT02971228

Feasibility Trial Testing the Bionic Pancreas With ZP4207

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MGH Diabetes Center

Boston, Massachusetts, 02114, United States

About this study

This was a single-center, open-label, 2-part, randomized cross-over trial. The trial was to enrol up to 20 adult patients with type 1 diabetes mellitus and assess the safety and efficacy of the Bionic Pancreas (BP) using either the iLet or iPhone platform when used with the glucagon analogue ZP4207 (dasiglucagon) versus Lilly glucagon.

In Part 1, patients participated in two 1-day treatment arms in random order (iPhone-based BP using ZP4207 (dasiglucagon) and iPhone-based BP using Lilly glucagon) according to a pre-generated randomization scheme. In Part 2, it was planned to enrol additional patients to participate in two 1-day treatment arms in random order (iLet using ZP4207 (dasiglucagon) and iLet using Lilly glucagon) according to a 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.

One day the BP will use glucagon analogue ZP4207 (dasiglucagon) and the other day the BP will use Lilly glucagon. Subjects will also receive insulin lispro through the BP on both days. The trial will be conducted at single center, the Massachusetts General Hospital Diabetes Center in Boston, MA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with T1DM for at least 1 year, as defined by the American Diabetes Association
  • Age ≥ 18 years
  • Prescription medication regimen stable for >1 month (except for medications not expected to affect trial safety or outcome, in the judgment of the investigator)
  • Diabetes managed using an insulin pump for >=6 months
  • 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

  • Previous exposure to ZP4207 or adverse reaction to glucagon
  • History of liver disease or current abnormal liver function tests (LFTs)
  • Renal failure
  • Anemia
  • History of coronary artery disease or congestive heart failure (class III or IV)
  • History of transient ischemic attack or stroke
  • Seizure disorder
  • Cystic fibrosis, pancreatitis, or any other pancreatic disease besides T1DM
  • Other endocrine disorders
  • Use of oral anti-diabetic medications
  • Electronically powered implants
  • Hypertension (≥160/100 mm Hg despite treatment)
  • Inadequate venous (vein) access as determined by trial nurse or physician at time of screening

Treatment and study plan

Insulin Lispro

Drug

Used to lower blood glucose. Commercially available by prescription and is indicated for patients with type 1 diabetes mellitus (T1DM), but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.

Other names: HumaLOG, HumaLOG Cartridge, HumaLOG KwikPen

ZP4207 (dasiglucagon)

Drug

A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.

Other names: dasiglucagon

glucagon

Drug

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.

Other names: Glucagon for injection (rDNA original)

iPhone-based bionic pancreas

Device

An experimental device.

iLet-based bionic pancreas

Device

An experimental device.

Primary outcomes

  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

    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

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

    Time frame: 16 hours

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    Technical faults related to connectivity issues were listed

  12. Diabetes Treatment Satisfaction Questionnaire - Status

    Time frame: Up to 3 months

    This questionnaire was not assessed as per protocol amendment 7.

  13. Diabetes Treatment Satisfaction Questionnaire - Change

    Time frame: Up to 3 months

    This questionnaire was not assessed as per protocol amendment 7.

  14. T1-Diabetes Distress Scale

    Time frame: Up to 3 months

    This questionnaire was not assessed as per protocol amendment 7.

  15. Problem Areas in Diabetes Survey

    Time frame: Up to 3 months

    This questionnaire was not assessed as per protocol amendment 7.

  16. Hypoglycemia Fear Survey

    Time frame: Up to 3 months

    This questionnaire was not assessed as per protocol amendment 7.

  17. Impact of Daily Diabetes Demands

    Time frame: Up to 3 months

    This questionnaire was not assessed as per protocol amendment 7.

  18. Bionic Pancreas User Opinion Survey

    Time frame: Up to 3 months

    This questionnaire was not assessed as per protocol amendment 7.

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Collaborators

  • Beta Bionics, Inc.
  • Massachusetts General Hospital

Registry information

Official study title

The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207

Acronym: dasiglucagon

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2016
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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