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Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multiplex pharmacokinetic profiling
Continuous insulin monitoring
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Pharmacokinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Multiplex pharmacokinetic profiling

Continuous insulin monitoring

Arm Description

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 (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.

Outcomes

Primary Outcome Measures

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
For Continuous Insulin Monitoring: Time to Maximum Plasma Insulin and Time to Maximum Continuous Insulin Monitoring Insulin

Secondary Outcome Measures

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.
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%
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.
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.

Full Information

First Posted
August 21, 2012
Last Updated
November 21, 2019
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01684943
Brief Title
Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling
Official Title
Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiplex pharmacokinetic profiling
Arm Type
Experimental
Arm Description
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.
Arm Title
Continuous insulin monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multiplex pharmacokinetic profiling
Intervention Type
Other
Intervention Name(s)
Continuous insulin monitoring
Primary Outcome Measure Information:
Title
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
Description
The average difference in tmax between lispro and aspart in all participants
Time Frame
10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose
Title
For Continuous Insulin Monitoring: Time to Maximum Plasma Insulin and Time to Maximum Continuous Insulin Monitoring Insulin
Time Frame
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 Outcome Measure Information:
Title
Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual
Description
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.
Time Frame
Baseline
Title
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%
Time Frame
10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose
Title
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
Description
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.
Time Frame
Baseline
Title
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
Description
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.
Time Frame
1 month prior to study entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling

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