Feasibility Trial Testing the Bionic Pancreas With ZP4207

Diabetes Mellitus, Type 1 Clinical Trial

— dasiglucagon  

Official title:

The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971228
• Other study ID #: ZP4207-16051
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: June 7, 2017

Study information

• Verified date: February 2021
• Source: Zealand Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 7, 2017
• Est. primary completion date: May 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Insulin Lispro
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.
• 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.

Device:
• iPhone-based bionic pancreas
An experimental device.
• iLet-based bionic pancreas
An experimental device.

Locations

Country	Name	City	State
United States	MGH Diabetes Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Zealand Pharma	Beta Bionics, Inc., Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters	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	Pain Measured on a Visual Analog Scale (VAS)	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
Secondary	Nausea Measured on a Visual Analog Scale (VAS)	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
Secondary	Glycemic Regulation	Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor [CGM] glucose<60mg/dL)	16 hours
Secondary	Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.	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
Secondary	Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.	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
Secondary	Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data	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
Secondary	Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured	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
Secondary	CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM	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
Secondary	CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download	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
Secondary	Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues	Technical faults in terms of calibration issues were listed by patient.	16 hours
Secondary	Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues	Technical faults related to connectivity issues were listed	16 hours
Secondary	Diabetes Treatment Satisfaction Questionnaire - Status	This questionnaire was not assessed as per protocol amendment 7.	Up to 3 months
Secondary	Diabetes Treatment Satisfaction Questionnaire - Change	This questionnaire was not assessed as per protocol amendment 7.	Up to 3 months
Secondary	T1-Diabetes Distress Scale	This questionnaire was not assessed as per protocol amendment 7.	Up to 3 months
Secondary	Problem Areas in Diabetes Survey	This questionnaire was not assessed as per protocol amendment 7.	Up to 3 months
Secondary	Hypoglycemia Fear Survey	This questionnaire was not assessed as per protocol amendment 7.	Up to 3 months
Secondary	Impact of Daily Diabetes Demands	This questionnaire was not assessed as per protocol amendment 7.	Up to 3 months
Secondary	Bionic Pancreas User Opinion Survey	This questionnaire was not assessed as per protocol amendment 7.	Up to 3 months