Feasibility Trial Testing the Bionic Pancreas With ZP4207 (dasiglucagon)
February 26, 2021 updated by: Zealand Pharma
The Bionic Pancreas 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
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- MGH Diabetes Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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:
A glucagon analog not yet approved by the FDA.
Subcutaneous administration in one BP arm.
Other Names:
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:
An experimental device.
|
|
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.
|
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:
A glucagon analog not yet approved by the FDA.
Subcutaneous administration in one BP arm.
Other Names:
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:
An experimental device.
|
|
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.
|
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:
A glucagon analog not yet approved by the FDA.
Subcutaneous administration in one BP arm.
Other Names:
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:
An experimental device.
|
|
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.
|
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:
A glucagon analog not yet approved by the FDA.
Subcutaneous administration in one BP arm.
Other Names:
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:
An experimental device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Up to 50 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
16 hours
|
|
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.
|
16 hours
|
|
Glycemic Regulation
Time Frame: 16 hours
|
Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor [CGM] glucose<60mg/dL)
|
16 hours
|
|
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.
|
16 hours
|
|
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.
|
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
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.
|
16 hours
|
|
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.
|
16 hours
|
|
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.
|
16 hours
|
|
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.
|
16 hours
|
|
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.
|
16 hours
|
|
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
|
16 hours
|
|
Diabetes Treatment Satisfaction Questionnaire - Status
Time Frame: Up to 3 months
|
This questionnaire was not assessed as per protocol amendment 7.
|
Up to 3 months
|
|
Diabetes Treatment Satisfaction Questionnaire - Change
Time Frame: Up to 3 months
|
This questionnaire was not assessed as per protocol amendment 7.
|
Up to 3 months
|
|
T1-Diabetes Distress Scale
Time Frame: Up to 3 months
|
This questionnaire was not assessed as per protocol amendment 7.
|
Up to 3 months
|
|
Problem Areas in Diabetes Survey
Time Frame: Up to 3 months
|
This questionnaire was not assessed as per protocol amendment 7.
|
Up to 3 months
|
|
Hypoglycemia Fear Survey
Time Frame: Up to 3 months
|
This questionnaire was not assessed as per protocol amendment 7.
|
Up to 3 months
|
|
Impact of Daily Diabetes Demands
Time Frame: Up to 3 months
|
This questionnaire was not assessed as per protocol amendment 7.
|
Up to 3 months
|
|
Bionic Pancreas User Opinion Survey
Time Frame: Up to 3 months
|
This questionnaire was not assessed as per protocol amendment 7.
|
Up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven J Russell, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
May 24, 2017
Study Completion (Actual)
June 7, 2017
Study Registration Dates
First Submitted
November 3, 2016
First Submitted That Met QC Criteria
November 17, 2016
First Posted (Estimate)
November 22, 2016
Study Record Updates
Last Update Posted (Actual)
March 23, 2021
Last Update Submitted That Met QC Criteria
February 26, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Incretins
- Glucagon
- Insulin Lispro
- Pancrelipase
- Pancreatin
- Glucagon-Like Peptide 1
Other Study ID Numbers
- ZP4207-16051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.