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Feasibility Trial Testing the Bionic Pancreas With ZP4207 — dasiglucagon  

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02971228
Study type Interventional
Source Zealand Pharma
Contact
Status Completed
Phase Phase 2
Start date November 2016
Completion date June 7, 2017
View Details
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