Feasibility Trial Testing the Bionic Pancreas With ZP4207

NCT ID: NCT02971228

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-06-07

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1, Lilly glucagon then ZP4207

In Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme.

Group Type: EXPERIMENTAL

Insulin Lispro

Intervention Type: DRUG

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.

ZP4207 (dasiglucagon)

Intervention Type: DRUG

A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.

Glucagon

Intervention Type: DRUG

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.

iPhone-based bionic pancreas

Intervention Type: DEVICE

An experimental device.

Part 1, ZP4207 then Lilly Glucagon

In Part 1, 12 patients participated in 1-day treatment arms in random order (iPhone-based Bionic Pancreas using Lilly glucagon and iPhone-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to pre-generated randomization scheme.

Group Type: EXPERIMENTAL

Insulin Lispro

Intervention Type: DRUG

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.

ZP4207 (dasiglucagon)

Intervention Type: DRUG

A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.

Glucagon

Intervention Type: DRUG

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.

iPhone-based bionic pancreas

Intervention Type: DEVICE

An experimental device.

Part 2, Lilly glucagon then ZP4207

In Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to 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.

Group Type: EXPERIMENTAL

Insulin Lispro

Intervention Type: DRUG

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.

ZP4207 (dasiglucagon)

Intervention Type: DRUG

A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.

Glucagon

Intervention Type: DRUG

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.

iLet-based bionic pancreas

Intervention Type: DEVICE

An experimental device.

Part 2, ZP4207 then Lilly Glucagon

In Part 2, it was planned to enrol up to 10 new patients to participate in 1-day treatment arms in random order (iLet-based Bionic Pancreas using Lilly glucagon and iLet-based Bionic Pancreas using ZP4207 (dasiglucagon) {experimental drug} with insulin lispro) according to 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.

Group Type: EXPERIMENTAL

Insulin Lispro

Intervention Type: DRUG

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.

ZP4207 (dasiglucagon)

Intervention Type: DRUG

A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.

Glucagon

Intervention Type: DRUG

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.

iLet-based bionic pancreas

Intervention Type: DEVICE

An experimental device.

Interventions

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.

Intervention Type: DRUG

ZP4207 (dasiglucagon)

A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.

Intervention Type: 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.

Intervention Type: DRUG

iPhone-based bionic pancreas

An experimental device.

Intervention Type: DEVICE

iLet-based bionic pancreas

An experimental device.

Intervention Type: DEVICE

Other Intervention Names

HumaLOG; HumaLOG Cartridge; HumaLOG KwikPen; dasiglucagon; Glucagon for injection (rDNA original)

Eligibility Criteria

Inclusion Criteria

1. Patients with T1DM for at least 1 year, as defined by the American Diabetes Association

2. Age ≥ 18 years

3. Prescription medication regimen stable for >1 month (except for medications not expected to affect trial safety or outcome, in the judgment of the investigator)

4. Diabetes managed using an insulin pump for >=6 months

5. Patients in good health according to age (medical history, physical examination, vital signs, 12-lead electrocardiograms [ECGs], laboratory assessments), as judged by the Investigator

Exclusion Criteria

1. Previous exposure to ZP4207 or adverse reaction to glucagon

2. History of liver disease or current abnormal liver function tests (LFTs)

3. Renal failure

4. Anemia

5. History of coronary artery disease or congestive heart failure (class III or IV)

6. History of transient ischemic attack or stroke

7. Seizure disorder

8. Cystic fibrosis, pancreatitis, or any other pancreatic disease besides T1DM

9. Other endocrine disorders

10. Use of oral anti-diabetic medications

11. Electronically powered implants

12. Hypertension (≥160/100 mm Hg despite treatment)

13. Inadequate venous (vein) access as determined by trial nurse or physician at time of screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Beta Bionics, Inc.

INDUSTRY

Sponsor Role: collaborator

Zealand Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven J Russell, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

MGH Diabetes Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

ZP4207-16051

Identifier Type: -

Identifier Source: org_study_id