Clinical trial NCT02971228: Feasibility Trial Testing the Bionic Pancreas With ZP4207
Official title: The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Keywords: glucagon
Type 1 diabetes mellitus
Bionic Pancreas
diabetes
iLet
iPhone
Beta Bionics
Anti-hypoglycemia
Glucagon Analog
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: Beta Bionics, Inc.
First posted: 2016-11-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
timeFrame: Up to 50 days
Secondary outcomes:
measure: Pain Measured on a Visual Analog Scale (VAS)
timeFrame: 16 hours
measure: Nausea Measured on a Visual Analog Scale (VAS)
timeFrame: 16 hours
measure: Glycemic Regulation
timeFrame: 16 hours
measure: Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
timeFrame: 16 hours
measure: Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.
timeFrame: 16 hours
measure: Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data
timeFrame: 16 hours
measure: Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured
timeFrame: 16 hours
measure: CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM
timeFrame: 16 hours
measure: CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download
timeFrame: 16 hours
measure: Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues
timeFrame: 16 hours
measure: Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues
timeFrame: 16 hours
measure: Diabetes Treatment Satisfaction Questionnaire - Status
timeFrame: Up to 3 months
measure: Diabetes Treatment Satisfaction Questionnaire - Change
timeFrame: Up to 3 months
measure: T1-Diabetes Distress Scale
timeFrame: Up to 3 months
measure: Problem Areas in Diabetes Survey
timeFrame: Up to 3 months
measure: Hypoglycemia Fear Survey
timeFrame: Up to 3 months
measure: Impact of Daily Diabetes Demands
timeFrame: Up to 3 months
measure: Bionic Pancreas User Opinion Survey
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Diabetes Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven J Russell, MD
role: PRINCIPAL_INVESTIGATOR
References: