Trial Outcomes & Findings for Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling (NCT NCT01684943)
NCT ID: NCT01684943
Last Updated: 2019-12-12
Results Overview
The average difference in tmax between lispro and aspart in all participants
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose
Results posted on
2019-12-12
Participant Flow
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.
Participant milestones
| Measure |
Multiplex Pharmacokinetic (PK) Profiling
Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin
Multiplex pharmacokinetic profiling
|
Continuous Insulin Monitoring (CIM)
Continuous insulin monitoring of insulin lispro
Continuous insulin monitoring
|
Multiplex PK Profiling and Continuous Insulin Monitoring
Subjects that participated in both the multiplex PK profiling experiments and the continuous insulin monitoring experiments
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
3
|
1
|
|
Overall Study
COMPLETED
|
20
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
1
|
1
|
Reasons for withdrawal
| Measure |
Multiplex Pharmacokinetic (PK) Profiling
Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin
Multiplex pharmacokinetic profiling
|
Continuous Insulin Monitoring (CIM)
Continuous insulin monitoring of insulin lispro
Continuous insulin monitoring
|
Multiplex PK Profiling and Continuous Insulin Monitoring
Subjects that participated in both the multiplex PK profiling experiments and the continuous insulin monitoring experiments
|
|---|---|---|---|
|
Overall Study
Inadequate Venous Access
|
3
|
0
|
0
|
|
Overall Study
Principal Investigator Determination
|
1
|
0
|
0
|
|
Overall Study
Excluded from Analysis
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
0
|
|
Overall Study
Planning Pregnancy
|
1
|
0
|
0
|
Baseline Characteristics
Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling
Baseline characteristics by cohort
| Measure |
Multiplex Pharmacokinetic Profiling
n=29 Participants
Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin
Multiplex pharmacokinetic profiling
|
Continuous Insulin Monitoring
n=3 Participants
Continuous insulin monitoring of insulin lispro
Continuous insulin monitoring
|
Multiplex PK Profiling and Continuous Insulin Monitoring
n=1 Participants
Participated in both study phases, the multiplex PK profiling visits and the CIM visits
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
47.09 years
STANDARD_DEVIATION 14.83 • n=5 Participants
|
37.97 years
STANDARD_DEVIATION 26.40 • n=7 Participants
|
74.65 years
n=5 Participants
|
47.09 years
STANDARD_DEVIATION 16.25 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
25 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after doseThe average difference in tmax between lispro and aspart in all participants
Outcome measures
| Measure |
All Participants
n=21 Participants
All participants who completed the MultiPK visits
|
Experiment #4
This includes the data from experiment #4. 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.
|
Participants Where the Two Insulins Were the Same
Participants who we determined had no difference in the tmax between the two analogs
|
|---|---|---|---|
|
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
|
24.28 minutes
Standard Deviation 41.29
|
—
|
—
|
PRIMARY outcome
Timeframe: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dosePopulation: 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
Outcome measures
| Measure |
All Participants
n=1 Participants
All participants who completed the MultiPK visits
|
Experiment #4
n=1 Participants
This includes the data from experiment #4. 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.
|
Participants Where the Two Insulins Were the Same
Participants who we determined had no difference in the tmax between the two analogs
|
|---|---|---|---|
|
For Continuous Insulin Monitoring: Time to Maximum Plasma Insulin and Time to Maximum Continuous Insulin Monitoring Insulin
Plasma insulin tmax
|
40 minutes
|
60 minutes
|
—
|
|
For Continuous Insulin Monitoring: Time to Maximum Plasma Insulin and Time to Maximum Continuous Insulin Monitoring Insulin
CIM insulin tmax
|
44 minutes
|
106 minutes
|
—
|
SECONDARY outcome
Timeframe: BaselineSubjects 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.
Outcome measures
| Measure |
All Participants
n=5 Participants
All participants who completed the MultiPK visits
|
Experiment #4
n=2 Participants
This includes the data from experiment #4. 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.
|
Participants Where the Two Insulins Were the Same
n=14 Participants
Participants who we determined had no difference in the tmax between the two analogs
|
|---|---|---|---|
|
Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual
|
8.1 percentage of glycosylated hemoglobin
Standard Deviation 1.1
|
8.6 percentage of glycosylated hemoglobin
Standard Deviation 1.8
|
7.5 percentage of glycosylated hemoglobin
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after doseOutcome measures
| Measure |
All Participants
n=21 Participants
All participants who completed the MultiPK visits
|
Experiment #4
This includes the data from experiment #4. 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.
|
Participants Where the Two Insulins Were the Same
Participants who we determined had no difference in the tmax between the two analogs
|
|---|---|---|---|
|
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%
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselineSubjects 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.
Outcome measures
| Measure |
All Participants
n=20 Participants
All participants who completed the MultiPK visits
|
Experiment #4
n=1 Participants
This includes the data from experiment #4. 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.
|
Participants Where the Two Insulins Were the Same
Participants who we determined had no difference in the tmax between the two analogs
|
|---|---|---|---|
|
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
|
7.8 percentage of glycosylated hemoglobin
Standard Deviation 1.2
|
7.3 percentage of glycosylated hemoglobin
Standard Deviation NA
Only one subject used an insulin analog at baseline that had a tmax \> 60 minutes, so no standard deviation calculation is possible
|
—
|
SECONDARY outcome
Timeframe: 1 month prior to study entrySubjects 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.
Outcome measures
| Measure |
All Participants
n=5 Participants
All participants who completed the MultiPK visits
|
Experiment #4
n=2 Participants
This includes the data from experiment #4. 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.
|
Participants Where the Two Insulins Were the Same
n=14 Participants
Participants who we determined had no difference in the tmax between the two analogs
|
|---|---|---|---|
|
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
|
8.6 events in the month prior to study entry
Standard Deviation 12.1
|
15.0 events in the month prior to study entry
Standard Deviation 15.6
|
13.1 events in the month prior to study entry
Standard Deviation 13.9
|
Adverse Events
Multiplex Pharmacokinetic Profiling Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Continuous Insulin Monitoring Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Both Multiplex PK and Continuous Insulin Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place