The Bionic Pancreas Feasibility Trial Testing the Bionic Pancreas With ZP4207
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Previous exposure to ZP4207 or adverse reaction to glucagon
- •History of liver disease or current abnormal liver function tests (LFTs)
- •Renal failure
- •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
研究组 & 干预措施
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.
干预措施: Insulin Lispro (Drug)
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.
干预措施: ZP4207 (dasiglucagon) (Drug)
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.
干预措施: Glucagon (Drug)
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.
干预措施: iPhone-based bionic pancreas (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.
干预措施: Insulin Lispro (Drug)
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.
干预措施: ZP4207 (dasiglucagon) (Drug)
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.
干预措施: Glucagon (Drug)
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.
干预措施: iPhone-based bionic pancreas (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.
干预措施: Insulin Lispro (Drug)
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.
干预措施: ZP4207 (dasiglucagon) (Drug)
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.
干预措施: Glucagon (Drug)
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.
干预措施: iLet-based bionic pancreas (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.
干预措施: Insulin Lispro (Drug)
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.
干预措施: ZP4207 (dasiglucagon) (Drug)
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.
干预措施: Glucagon (Drug)
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.
干预措施: iLet-based bionic pancreas (Device)
结局指标
主要结局
Safety and Tolerability as Measured by Adverse Events, Local Tolerability of Infusion Site Reactions, and Clinical Laboratory Parameters
时间窗: Up to 50 days
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.
次要结局
- Nausea Measured on a Visual Analog Scale (VAS)(16 hours)
- Hypoglycemia Fear Survey(Up to 3 months)
- Pain 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)
- Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data(16 hours)
- Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured(16 hours)
- Diabetes Treatment Satisfaction Questionnaire - Status(Up to 3 months)
- CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM(16 hours)
- CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download(16 hours)
- Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues(16 hours)
- Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues(16 hours)
- Diabetes Treatment Satisfaction Questionnaire - Change(Up to 3 months)
- T1-Diabetes Distress Scale(Up to 3 months)
- Problem Areas in Diabetes Survey(Up to 3 months)
- Impact of Daily Diabetes Demands(Up to 3 months)
- Bionic Pancreas User Opinion Survey(Up to 3 months)