Phase 2
Completed N=13
Feasibility Trial Testing the Bionic Pancreas With ZP4207
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02971228 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters — 8; 12; 0; 0 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters |
8; 12; 0; 0; 0; 0 | — |
| SECONDARY Pain Measured on a Visual Analog Scale (VAS) |
0.00; 0.01; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Nausea Measured on a Visual Analog Scale (VAS) |
0.00; 0.00; 0.12; 0.00; 0.00; 0.00 | — |
| SECONDARY Glycemic Regulation |
12.78; 17.60 | 0.2518 |
| SECONDARY Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. |
96.73; 97.01 | 0.8508 |
| SECONDARY Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. |
98.36; 97.73 | 0.1847 |
| 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 |
95.41; 94.26 | — |
| SECONDARY Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured |
97.86; 96.31 | — |
| SECONDARY CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM |
97.55; 97.94 | — |
| SECONDARY CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download |
12.6; 12.7 | — |
| SECONDARY Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues |
9; 11 | — |
| SECONDARY Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues |
3; 2 | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire - Status |
— | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire - Change |
— | — |
| SECONDARY T1-Diabetes Distress Scale |
— | — |
| SECONDARY Problem Areas in Diabetes Survey |
— | — |
| SECONDARY Hypoglycemia Fear Survey |
— | — |
| SECONDARY Impact of Daily Diabetes Demands |
— | — |
| SECONDARY Bionic Pancreas User Opinion Survey |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02971228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.