Feasibility Trial Testing the Bionic Pancreas With ZP4207

NCT02971228 | Completed Phase 2 Results DMC

• 1 other identifier: ZP4207-16051
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 1

Keywords

glucagon; Type 1 diabetes mellitus; Bionic Pancreas; diabetes; iLet; iPhone; Beta Bionics; Anti-hypoglycemia; Glucagon Analog

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters

  Safety and tolerability of ZP4207 in the BP using either the iPhone or the iLet platform, as measured by adverse events (AEs), local tolerability of infusion site reactions, and clinical laboratory parameters. See adverse events section for results on AEs by system organ class and preferred term. Clinical laboratory parameters in terms of overall 'investigations' AEs and abnormal hematology parameters that did not resolve by the follow-up visit are presented below. LLN = lower limit of the normal range. Investigations and vital signs AEs by preferred term are presented in the AE section. Participants with infusion site pain and nausea measured by visual analog scales (VAS) are presented below; mean values are presented under secondary outcomes. For the VAS, individuals marked on a 10-cm line corresponding to the amount of pain or nausea being experienced, with low scores (cm) indicating no feelings of pain or nausea and high scores (cm) indicating high feelings of pain or nausea.

  Up to 50 days

Secondary Outcomes (18)

• Pain Measured on a Visual Analog Scale (VAS)

  16 hours

• Nausea Measured on a Visual Analog Scale (VAS)

  16 hours

• Glycemic Regulation

  16 hours

• Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

  16 hours

• Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.

  16 hours

Study Arms (4)

Part 1, Lilly glucagon then ZP4207

EXPERIMENTAL

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.

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

Part 1, ZP4207 then Lilly Glucagon

EXPERIMENTAL

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.

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

Part 2, Lilly glucagon then ZP4207

EXPERIMENTAL

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.

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

Part 2, ZP4207 then Lilly Glucagon

EXPERIMENTAL

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.

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

Interventions

Insulin Lispro 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.

Also known as: HumaLOG, HumaLOG Cartridge, HumaLOG KwikPen

Part 1, Lilly glucagon then ZP4207; Part 1, ZP4207 then Lilly Glucagon; Part 2, Lilly glucagon then ZP4207; Part 2, ZP4207 then Lilly Glucagon

ZP4207 (dasiglucagon) DRUG

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

Also known as: dasiglucagon

Part 1, Lilly glucagon then ZP4207; Part 1, ZP4207 then Lilly Glucagon; Part 2, Lilly glucagon then ZP4207; Part 2, ZP4207 then Lilly Glucagon

Glucagon 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.

Also known as: Glucagon for injection (rDNA original)

Part 1, Lilly glucagon then ZP4207; Part 1, ZP4207 then Lilly Glucagon; Part 2, Lilly glucagon then ZP4207; Part 2, ZP4207 then Lilly Glucagon

iPhone-based bionic pancreas DEVICE

An experimental device.

Part 1, Lilly glucagon then ZP4207; Part 1, ZP4207 then Lilly Glucagon

iLet-based bionic pancreas DEVICE

An experimental device.

Part 2, Lilly glucagon then ZP4207; Part 2, ZP4207 then Lilly Glucagon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Zealand Pharma: lead
• Massachusetts General Hospital: collaborator
• Beta Bionics, Inc.: collaborator

Study Sites (1)

MGH Diabetes Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Insulin Lispro; dasiglucagon; Glucagon; Injections

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proglucagon; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Kim Mark Knudsen
• Organization: Zealand Pharma A/S

KMKnudsen@zealandpharma.com

+45 5060 3780

Study Officials

• Steven J Russell, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 22, 2016
• Study Start: November 1, 2016
• Primary Completion: May 24, 2017
• Study Completion: June 7, 2017
• Last Updated: March 23, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)