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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Beta Bionics, Inc. | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Measured on a Visual Analog Scale (VAS) | The VAS scale was used to measure pain at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of pain. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of pain being experienced, with low scores (cm) indicating no feelings of pain and high scores (cm) indicating high feelings of pain. Actual values are shown. The maximum value in the Lilly glucagon group was recorded at hour 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Russell, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Diabetes Center | Boston | Massachusetts | 02114 | United States |
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Part 2 was designed to enroll up to 10 new patients in two 1-day treatment arms in random order (iLet using ZP4207 or Lilly Glucagon). 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.
In Part 1, it was planned to enrol 10 patients in two 1-day treatment arms in random order (iPhone-based bionic pancreas using ZP4207 or Lilly Glucagon) according to a pre-generated randomization scheme. The trial had a crossover design. In all, 19 patients were screened and 13 were randomized, but 1 patient withdrew before treatment. Thus, 12 patients were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 Lilly Glucagon or ZP4207 | 1 patient was enrolled but withdrew prior to treatment with either trial drug |
| FG001 | Part 1, Lilly Glucagon Then ZP4207 | 7 patients received Lilly Glucagon then ZP4207 in this treatment sequence (2 withdrew before receiving ZP4207). Insulin Lispro was also administered in both treatment arms. Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs. ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration. 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. iPhone-based bionic pancreas: An experimental device. |
| FG002 | Part 1, ZP4207 Then Lilly Glucagon | 5 patients received ZP4207 then Lilly Glucagon in this treatment sequence. Insulin Lispro was also administered in both treatment arms. Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs. ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration. 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. iPhone-based bionic pancreas: An experimental device. |
| FG003 | Part 2, ZP4207 Then Lilly Glucagon | Part 2 of the trial was not conducted - see above. |
| FG004 | Part 2, Lilly Glucagon Then ZP4207 | Part 2 of the trial was not conducted - see above. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Due to the crossover nature of the trial, demographic and baseline characteristics are summarized for the overall population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1, All Participants | 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. Note: 13 patients were enrolled and 1 patient withdrew prior to treatment with either trial drug; thus, 12 patients were randomized and treated. Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose. ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm. 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. iPhone-based bionic pancreas: An experimental device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Count of Participants | Participants | Up to 50 days |
Up to 50 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1, ZP4207 | In Part 1, 10 patients received treatment with ZP4207 (dasiglucagon) {experimental drug} with insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme. Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose. ZP4207 (dasiglucagon): A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm. iPhone-based bionic pancreas: An experimental device. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Mark Knudsen | Zealand Pharma A/S | +45 5060 3780 | KMKnudsen@zealandpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 10, 2017 | Feb 26, 2021 | SAP_002.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 10, 2017 | Feb 26, 2021 | Prot_003.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Not provided
| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| C000710373 | dasiglucagon |
| D005934 | Glucagon |
| D007267 | Injections |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
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Not provided
Not provided
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Not provided
Not provided
| 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. |
|
|
|
| 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. |
|
| 16 hours |
| Nausea Measured on a Visual Analog Scale (VAS) | The VAS scale was used to measure nausea at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of nausea. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of nausea being experienced, with low scores (cm) indicating no feelings of nausea and high scores (cm) indicating high feelings of nausea. Actual values are shown. The maximum values in both groups were recorded at hour 6, the start of the exercise period. | 16 hours |
| Glycemic Regulation | Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor [CGM] glucose<60mg/dL) | 16 hours |
| Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | 16 hours |
| Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | 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 | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | 16 hours |
| Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | 16 hours |
| CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | 16 hours |
| CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | 16 hours |
| Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues | Technical faults in terms of calibration issues were listed by patient. | 16 hours |
| Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues | Technical faults related to connectivity issues were listed | 16 hours |
| Diabetes Treatment Satisfaction Questionnaire - Status | This questionnaire was not assessed as per protocol amendment 7. | Up to 3 months |
| Diabetes Treatment Satisfaction Questionnaire - Change | This questionnaire was not assessed as per protocol amendment 7. | Up to 3 months |
| T1-Diabetes Distress Scale | This questionnaire was not assessed as per protocol amendment 7. | Up to 3 months |
| Problem Areas in Diabetes Survey | This questionnaire was not assessed as per protocol amendment 7. | Up to 3 months |
| Hypoglycemia Fear Survey | This questionnaire was not assessed as per protocol amendment 7. | Up to 3 months |
| Impact of Daily Diabetes Demands | This questionnaire was not assessed as per protocol amendment 7. | Up to 3 months |
| Bionic Pancreas User Opinion Survey | This questionnaire was not assessed as per protocol amendment 7. | Up to 3 months |
| Logistical challenges |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes duration | Mean | Standard Deviation | years |
|
| HbA1c | Mean | Standard Deviation | % |
|
|
|
|
| Secondary | Pain Measured on a Visual Analog Scale (VAS) | The VAS scale was used to measure pain at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of pain. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of pain being experienced, with low scores (cm) indicating no feelings of pain and high scores (cm) indicating high feelings of pain. Actual values are shown. The maximum value in the Lilly glucagon group was recorded at hour 3. | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Mean | Standard Deviation | cm | 16 hours |
|
|
|
| Secondary | Nausea Measured on a Visual Analog Scale (VAS) | The VAS scale was used to measure nausea at the end of the visit (16 hours) for patients in both treatment groups. The VAS was a psychometric response scale used to measure subjective characteristics of nausea. Patients marked a location on a 0 to 10-cm line that corresponded to the amount of nausea being experienced, with low scores (cm) indicating no feelings of nausea and high scores (cm) indicating high feelings of nausea. Actual values are shown. The maximum values in both groups were recorded at hour 6, the start of the exercise period. | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Mean | Standard Deviation | cm | 16 hours |
|
|
|
| Secondary | Glycemic Regulation | Measure glycemic regulation, including hypoglycemia exposure (percent of time spent with continuous glucose monitor [CGM] glucose<60mg/dL) | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Mean | Standard Deviation | percentage of time points | 16 hours |
|
|
|
|
| Secondary | Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Mean | Standard Deviation | Percentage of treatment delivered | 16 hours |
|
|
|
|
| Secondary | Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump. | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Mean | Standard Deviation | Percentage of treatment delivered | 16 hours |
|
|
|
|
| Secondary | Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time Continuous Glucose Monitoring (CGM) Data | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Mean | Standard Deviation | percentage of time functioning nominally | 16 hours |
|
|
|
| Secondary | Average Percentage of Time During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Mean | Standard Deviation | percentage of time functioning nominally | 16 hours |
|
|
|
| Secondary | CGM Reliability Index, Calculated as Percentage of Possible Values Actually Recorded by CGM | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Mean | Standard Deviation | percentage of recorded values | 16 hours |
|
|
|
| Secondary | CGM Mean Absolute Relative Difference Versus Time-stamped Blood Glucose (BG) Values From Meter Download | Secondary endpoint of bionic pancreas function, presented by treatment group. The analysis of bionic pancreas function endpoints was on an intention-to-treat basis. | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Mean | Standard Deviation | mg/dL | 16 hours |
|
|
|
| Secondary | Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Calibration Issues | Technical faults in terms of calibration issues were listed by patient. | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Count of Participants | Participants | 16 hours |
|
|
|
| Secondary | Number of Patients With Technical Faults Associated With the BP Including Cause and Resolution: Connectivity Issues | Technical faults related to connectivity issues were listed | The full analysis set (intent-to-treat population) consisted of all randomized patients: 10 patients received ZP4207 treatment and 12 patients received Lilly Glucagon treatment in a crossover design. Results are presented by treatment received. Only Part 1 of the trial was conducted. | Posted | Count of Participants | Participants | 16 hours |
|
|
|
| Secondary | Diabetes Treatment Satisfaction Questionnaire - Status | This questionnaire was not assessed as per protocol amendment 7. | This questionnaire was not assessed as per protocol amendment 7. | Posted | Up to 3 months |
|
|
| Secondary | Diabetes Treatment Satisfaction Questionnaire - Change | This questionnaire was not assessed as per protocol amendment 7. | This questionnaire was not assessed as per protocol amendment 7. | Posted | Up to 3 months |
|
|
| Secondary | T1-Diabetes Distress Scale | This questionnaire was not assessed as per protocol amendment 7. | This questionnaire was not assessed as per protocol amendment 7. | Posted | Up to 3 months |
|
|
| Secondary | Problem Areas in Diabetes Survey | This questionnaire was not assessed as per protocol amendment 7. | This questionnaire was not assessed as per protocol amendment 7. | Posted | Up to 3 months |
|
|
| Secondary | Hypoglycemia Fear Survey | This questionnaire was not assessed as per protocol amendment 7. | This questionnaire was not assessed as per protocol amendment 7. | Posted | Up to 3 months |
|
|
| Secondary | Impact of Daily Diabetes Demands | This questionnaire was not assessed as per protocol amendment 7. | This questionnaire was not assessed as per protocol amendment 7. | Posted | Up to 3 months |
|
|
| Secondary | Bionic Pancreas User Opinion Survey | This questionnaire was not assessed as per protocol amendment 7. | This questionnaire was not assessed as per protocol amendment 7. | Posted | Up to 3 months |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 8 |
| 10 |
| EG001 | Part 1, Lilly Glucagon | In Part 1, 12 patients received treatment with Lilly glucagon and insulin lispro in the iPhone-based Bionic Pancreas according to a pre-generated randomization scheme. Insulin Lispro: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with T1DM, but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose. 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. iPhone-based bionic pancreas: An experimental device. | 0 | 12 | 0 | 12 | 12 | 12 |
| Palpitations | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA 19.0 | Systematic Assessment | AEs considered as "blood glucose decreased" were distinct from AEs considered as "hypoglycemia" |
|
| Lymphocyte count increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
Not provided
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D052336 | Proglucagon |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| Hour 2 |
|
| Hour 3 |
|
| Hour 4 |
|
| Hour 5 |
|
| Hour 6 |
|
| Hour 7 |
|
| Visit end (16 hours) |
|
| Hour 2 |
|
| Hour 3 |
|
| Hour 4 |
|
| Hour 5 |
|
| Hour 6 |
|
| Hour 7 |
|
| Visit end (16 hours) |
|
| Other |
A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis. |
| Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. | Wilcoxon (Mann-Whitney) | 0.2500 | Median Difference (Final Values) | -8.02 | 2-Sided | 95 | -25.85 | 10.68 | Other |
A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.
| Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. | Wilcoxon (Mann-Whitney) | >0.9999 | Median Difference (Final Values) | 0.03 | 2-Sided | 95 | -4.12 | 3.13 | Other |
A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.
| Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. | Wilcoxon (Mann-Whitney) | 0.0781 | Median Difference (Final Values) | 0.02 | 2-Sided | 95 | -0.01 | 3.09 | Other |