Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments multiplex pharmacokinetic profiling, continuous insulin monitoring
Phase phase 2
Sponsor Massachusetts General Hospital
Start date July 2010
End date September 2016
Trial size 33 participants
Trial identifier NCT01684943, 2010P001005

Summary

The investigators are doing this research study to compare the pharmacokinetics (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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Multiplex pharmacokinetic profiling of regular human insulin, insulin aspart, insulin lispro, insulin glulisine, and regular human insulin
multiplex pharmacokinetic profiling
(Experimental)
Continuous insulin monitoring of insulin lispro
continuous insulin monitoring

Primary Outcomes

Measure
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
time frame: 1 day
For Continuous Insulin Monitoring: Agreement between plots of insulin concentration in the blood and plots of insulin concentration in the microdialysate vs. time by both the CIM lab-on-a-chip and by immunoassays performed on fractions of microdialysate
time frame: 1 days

Secondary Outcomes

Measure
Multiplex PK: Correlation between HbA1c at study entry and use of insulin analog with most favorable PK as an outpatient for subjects with a difference in tmax between analogs.
time frame: 1 day
Multiplex PK: Fraction of subjects with difference in tmax between the analog with greatest and the analog with the least value of tmax that is > 25%
time frame: 1 day
Multiplex PK: Correlation between HbA1c at study entry and use of insulin analog with tmax < 60 minutes as an outpatient vs. use of an insulin analog with tmax > 60 minutes as an outpatient.
time frame: 1 day
Multiplex PK: Correlation between number of monthly self-reported or meter recorded incidents of hypoglycemia at study entry and use of insulin analog with best PK kinetics.
time frame: 1 day

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: - Age 12 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

Additional Information

Official title Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.