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The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207 (dasiglucagon)
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
Details
| Lead sponsor | Zealand Pharma |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 13 |
| Start date | 2016-11 |
| Completion | 2017-06-07 |
Conditions
- Diabetes Mellitus, Type 1
Interventions
- Insulin Lispro
- ZP4207 (dasiglucagon)
- Glucagon
- iPhone-based bionic pancreas
- iLet-based bionic pancreas
Primary outcomes
- Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters — 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.
Countries
United States