At a glance
ClinicalIndex Comparison Record- ✓Type 1 diabetes mellitus for at least 1 year
- ✓Age 18 years or older
- ✓Stable medication regimen for more than 1 month (excluding medications not expected to affect trial safety/outcome)
- ✓Insulin pump use for 6 months or longer
- ✕Prior exposure to ZP4207 or adverse reaction to glucagon
- ✕History of liver disease or abnormal liver function tests
- ✕Renal failure
- ✕Anemia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207
In Brief
A Phase 2 clinical trial evaluating Insulin Lispro, ZP4207 (dasiglucagon), and 3 other interventions for Diabetes Mellitus, Type 1. Completed, enrolled 13 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
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.
A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
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.
An experimental device.
An experimental device.