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Feasibility Trial Testing the Bionic Pancreas With ZP4207

NCT02971228 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-03-23

Study results available
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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

Conditions

  • Diabetes Mellitus, Type 1

Interventions

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Beta Bionics, Inc.

    collaborator INDUSTRY

  • Zealand Pharma

    lead INDUSTRY

Principal Investigators

  • Steven J Russell, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-05-24
Completion
2017-06-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02971228 on ClinicalTrials.gov