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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01684943
First received: August 21, 2012
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Drug: insulin analog administration
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Selecting Insulin Analogs for Closed-Loop Control Using Multiplex Pharmacokinetic Profiling

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Aggregate mean difference in tmax between the analog with greatest and the analog with the least value of tmax for individual subjects. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Designated as safety issue: No ]
    Subjects with a difference in tmax between analogs will be catagorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. Whether there is a difference between the median A1c between these three groups will be tested with the Kruskal-Wallis one-way analysis of variance test. In addition whether there is a difference in the fraction of subjects in these groups meeting their A1c goal of less than or equal to 7% (i.e. whether the analog choice and meeting the A1c target are independent) will be determined with the chi-square test.

  • Fraction of subjects with difference in tmax between the analog with greatest and the analog with the least value of tmax that is > 25% [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
    Subjects with a difference in tmax between analogs will be catagorized as follows: using insulin with tmax less than or equal to 60 minutes or using insulin with tmax > 60 minutes. Whether there is a difference between the median A1c between these two groups will be tested with the heteroskedastic Student's t test.

  • 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. [ Designated as safety issue: No ]
    Subjects with a difference in tmax between analogs will be catagorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. Whether there is a difference between the number of hypoglycemic episodes per month between these three groups will be tested with the Kruskal-Wallis one-way analysis of variance test. In addition whether there is a difference in the fraction of subjects in these groups with less than or equal to two episodes of hypoglycemia a week (i.e. whether the analog choice and the frequency of hypoglycemia are independent) will be determined with the chi-square test.


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Type 1 Diabetes Drug: insulin analog administration

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684943

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Steven J. Russell, MD, PhD, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01684943     History of Changes
Other Study ID Numbers: 2010P001005
Study First Received: August 21, 2012
Last Updated: March 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014