Feasibility Trial Testing the Bionic Pancreas With ZP4207 (dasiglucagon)

Zealand Pharma

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Glucagon; Drug: ZP4207 (dasiglucagon); Device: iLet-based bionic pancreas; Drug: Insulin Lispro; Device: iPhone-based bionic pancreas

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02971228

ZP4207-16051

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 4 patient groups

Part 1, Lilly glucagon then ZP4207

Experimental group

Description:

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.

Treatment:

Device: iPhone-based bionic pancreas

Drug: Insulin Lispro

Drug: ZP4207 (dasiglucagon)

Drug: Glucagon

Part 1, ZP4207 then Lilly Glucagon

Experimental group

Description:

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.

Treatment:

Device: iPhone-based bionic pancreas

Drug: Insulin Lispro

Drug: ZP4207 (dasiglucagon)

Drug: Glucagon

Part 2, Lilly glucagon then ZP4207

Experimental group

Description:

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.

Treatment:

Device: iLet-based bionic pancreas

Drug: Insulin Lispro

Drug: ZP4207 (dasiglucagon)

Drug: Glucagon

Part 2, ZP4207 then Lilly Glucagon

Experimental group

Description:

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.

Treatment:

Device: iLet-based bionic pancreas

Drug: Insulin Lispro

Drug: ZP4207 (dasiglucagon)

Drug: Glucagon