N/A
Completed N=33
Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling
Source: ClinicalTrials.gov NCT01684943 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: 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
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
24.28 | — |
| PRIMARY For Continuous Insulin Monitoring: Time to Maximum Plasma Insulin and Time to Maximum Continuous Insulin Monitoring Insulin |
40; 60; 44; 106 | — |
| 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 |
8.1; 8.6; 7.5 | — |
| 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% |
11 | — |
| 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 |
7.8; 7.3 | — |
| 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 |
8.6; 15.0; 13.1 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older with clinical type 1 diabetes for at least five years
- Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra).
- Ability to consume a sufficient amount of carbohydrates over 2-3 hours to cover 9 units of rapid acting insulin
Exclusion Criteria
- Unable to provide informed consent
- Unable to comply with study procedures
- Inadequate venous access as determined by study nurse or physician at time of screening.
- Pregnancy
- History of gastric banding, gastric bypass, or other gastrointestinal condition that may prevent a subject from consuming a normal sized meal
- Hemoglobin <13.5 for men, < 12 for women
Data sourced from ClinicalTrials.gov (NCT01684943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.