Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02971228 | Feasibility Trial Testing the Bionic Pancreas With ZP4207 | PHASE2 | COMPLETED | 13 | — | — | Nov 1, 2016 | Jun 7, 2017 | Mar 23, 2021 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| ZP4207 (dasiglucagon) | DRUG | A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm. |
| 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. |
| iPhone-based bionic pancreas | DEVICE | An experimental device. |
| iLet-based bionic pancreas | DEVICE | An experimental device. |
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. Di...