Feasibility Trial Testing the Bionic Pancreas With ZP4207

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 1

In brief

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

Key facts

Study ID

NCT02971228

Run by

Zealand Pharma

People needed

13

Starts

2016-11-01

Expected to finish

2017-06-07

Last updated by the study team

2021-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with T1DM for at least 1 year, as defined by the American Diabetes Association
• Age ≥ 18 years
• Prescription medication regimen stable for >1 month (except for medications not expected to affect trial safety or outcome, in the judgment of the investigator)
• Diabetes managed using an insulin pump for >=6 months
• Patients in good health according to age (medical history, physical examination, vital signs, 12-lead electrocardiograms [ECGs], laboratory assessments), as judged by the Investigator

You may not qualify if…

• Previous exposure to ZP4207 or adverse reaction to glucagon
• History of liver disease or current abnormal liver function tests (LFTs)
• Renal failure
• Anemia
• History of coronary artery disease or congestive heart failure (class III or IV)
• History of transient ischemic attack or stroke
• Seizure disorder
• Cystic fibrosis, pancreatitis, or any other pancreatic disease besides T1DM
• Other endocrine disorders
• Use of oral anti-diabetic medications
• Electronically powered implants
• Hypertension (≥160/100 mm Hg despite treatment)
• Inadequate venous (vein) access as determined by trial nurse or physician at time of screening

Where it is running

• MGH Diabetes Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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