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The investigators are doing this research study to compare the pharmacokinetics (PK) (rate of absorption) of insulin lispro (Humalog), insulin aspart (Novolog), and insulin glulisine (Apidra) within individual subjects.
Additionally, the investigators will perform a preliminary feasibility evaluation of a minimally invasive continuous insulin monitoring (CIM) device and its use to derive PK parameters in human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiplex pharmacokinetic profiling | Experimental | Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin. All subjects participated in the single study arm and received injections of each type of insulin. Blood samples were drawn at intervals for pharmacokinetic profiling. |
|
| Continuous insulin monitoring | Experimental | Continuous insulin monitoring (CIM) of insulin lispro. Some subjects participated in the CIM sub-study, which is distinct from the Multiplex Pharmacokinetic Profiling study. This intervention involved administering insulin lispro and monitoring pharmacokinetic profile of the drug using blood samples and an investigational continuous insulin monitoring system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiplex pharmacokinetic profiling | Other |
| ||
| Continuous insulin monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| For Multiplex PK Profiling: Aggregate Mean Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax for Individuals | The average difference in tmax between lispro and aspart in all participants | 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose |
| For Continuous Insulin Monitoring: Time to Maximum Plasma Insulin and Time to Maximum Continuous Insulin Monitoring Insulin | 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual | Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. The average A1c for each of the three categories is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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29 enrolled in Multiplex PK profiling, 9 were ineligible. 21 completed.
3 enrolled in the CIM arm of the trial. 2 completed, 1 was excluded from analysis.
1 subject enrolled in both study phases. They completed the MultiPK profiling experiments, but were excluded from the CIM analysis.
Total protocol enrollment was 33.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multiplex Pharmacokinetic (PK) Profiling | Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin Multiplex pharmacokinetic profiling |
| FG001 | Continuous Insulin Monitoring (CIM) | Continuous insulin monitoring of insulin lispro Continuous insulin monitoring |
| FG002 | Multiplex PK Profiling and Continuous Insulin Monitoring | Subjects that participated in both the multiplex PK profiling experiments and the continuous insulin monitoring experiments |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Multiplex Pharmacokinetic Profiling | Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin Multiplex pharmacokinetic profiling |
| BG001 | Continuous Insulin Monitoring |
| 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 | For Multiplex PK Profiling: Aggregate Mean Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax for Individuals | The average difference in tmax between lispro and aspart in all participants | Posted | Mean | Standard Deviation | minutes | 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose |
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During the 5-hour in-clinic visits, visits occurred over the course of 1 year on average
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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 | Multiplex Pharmacokinetic Profiling Only | Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin. This only includes subjects that participated in the Multiplex PK profiling part of the protocol and not the continuous insulin monitoring part of the protocol. Multiplex pharmacokinetic profiling |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtney A Balliro | Massachusetts General Hospital | 617-726-1242 | cballiro@partners.org |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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All subjects participated in the single arm of the study. Some subjects participated in the continuous insulin monitoring sub-study in addition to the main protocol, or separate from the main protocol.
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| Other |
|
| Baseline |
| Multiplex PK: Count of Subjects With Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax That is > 25% | 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose |
| Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog With Tmax < 60 Minutes vs. Use of an Insulin Analog With Tmax > 60 Minutes for Each Individual | Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with tmax less than or equal to 60 minutes or using insulin with tmax > 60 minutes. The average A1c per group is reported. | Baseline |
| Multiplex PK: Average Number of Hypoglycemia Events Over the Last Month at Baseline Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual | Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. The average number of hypoglycemic events per month per group is reported. | 1 month prior to study entry |
| Excluded from Analysis |
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| Lost to Follow-up |
|
| Planning Pregnancy |
|
Continuous insulin monitoring of insulin lispro Continuous insulin monitoring |
| BG002 | Multiplex PK Profiling and Continuous Insulin Monitoring | Participated in both study phases, the multiplex PK profiling visits and the CIM visits |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Primary | For Continuous Insulin Monitoring: Time to Maximum Plasma Insulin and Time to Maximum Continuous Insulin Monitoring Insulin | Only 2 of the 4 experiments conducted under the Continuous Insulin Monitoring sub-study protocol produced usable data for analysis. Those two experiments are both reported here | Posted | Number | minutes | 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose |
|
|
|
| Secondary | Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual | Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. The average A1c for each of the three categories is reported. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline |
|
|
|
| Secondary | Multiplex PK: Count of Subjects With Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax That is > 25% | Posted | Count of Participants | Participants | 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose |
|
|
|
| Secondary | Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog With Tmax < 60 Minutes vs. Use of an Insulin Analog With Tmax > 60 Minutes for Each Individual | Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with tmax less than or equal to 60 minutes or using insulin with tmax > 60 minutes. The average A1c per group is reported. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline |
|
|
|
| Secondary | Multiplex PK: Average Number of Hypoglycemia Events Over the Last Month at Baseline Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual | Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. The average number of hypoglycemic events per month per group is reported. | Posted | Mean | Standard Deviation | events in the month prior to study entry | 1 month prior to study entry |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Continuous Insulin Monitoring Only | Continuous insulin monitoring of insulin lispro. This only includes subjects that participated in the continuous insulin monitoring part of the protocol and did not participate in the Multiplex PK profiling part of the protocol. Continuous insulin monitoring | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Both Multiplex PK and Continuous Insulin Monitoring | Participants that enrolled and completed both parts of the trial. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |