NCT02971228

Feasibility Trial Testing the Bionic Pancreas With ZP4207

The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
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.
DRUG	ZP4207 (dasiglucagon)	A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
DRUG	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.
DEVICE	iLet-based bionic pancreas	An experimental device.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-05-24
• Completion: 2017-06-07
• First posted: 2016-11-22
• Last updated: 2021-03-23
• Results posted: 2021-02-08

Locations

1 site across 1 country: United States