Comparison of Insulins Aspart and Lispro in Insulin Pumps

This study has been completed.
Sponsor:
Information provided by:
Tulane University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00461331
First received: April 16, 2007
Last updated: April 19, 2011
Last verified: September 2010
  Purpose

The purpose of the study is to compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: Insulin Aspart
Drug: Insulin Lispro
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of the Efficacy Beyond 48 Hours of Insulin Aspart (Novolog) and Lispro (Humalog) in Insulin Pumps

Resource links provided by NLM:


Further study details as provided by Tulane University Health Sciences Center:

Primary Outcome Measures:
  • Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change [ Time Frame: 24 to 100 hours after last pump infusion line change ] [ Designated as safety issue: Yes ]
    For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level >300 mg/dL.


Secondary Outcome Measures:
  • Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place [ Time Frame: 48 to 100 hours after keeping the same pump infusion line in place ] [ Designated as safety issue: No ]
    Daily serum glycomark levels between day 3 and day 5 after the pump infusion line change. These levels were measured for both the test periods.

  • Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place [ Time Frame: Between 48, 72 and 96 hours after the last pump infusion line change ] [ Designated as safety issue: No ]
    Free 15-F2t isoprostane was measured between days 3 and 5 after the keeping the same pump infusion line in place. It is a marker of oxidative stress due to hyperglycemia that was being compared between the two test periods.


Enrollment: 20
Study Start Date: October 2004
Study Completion Date: August 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin 1
Either insulin Aspart or insulin Lispro were randomized to be insulin 1.
Drug: Insulin Aspart
Either one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study.
Other Names:
  • Insulin lispro - insulin Humalog
  • Insulin aspart - insulin Novolog
Active Comparator: Insulin 2
Between insulin Aspart and insulin Lispro, the one that was not used as insulin 1 was then used as the second insulin for the second arm of the study.
Drug: Insulin Lispro
Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.
Other Names:
  • Insulin Aspart
  • Insulin Lispro

Detailed Description:

Continuous subcutaneous insulin infusion (Insulin pump therapy) is a well established tool for the management of type 1 diabetes. In clinical trials, insulin pump therapy has been shown to have increased efficacy over multiple daily injections. However, the overall glycemic control in patients using insulin pumps has been disappointing. The recommended duration of "needle use" in insulin pump treatment is 48 hours, based on anecdotal observations.

One of the reasons for the suboptimal control may be that patients do not adhere to the advice of changing their pump infusion line every 48 hours. However, it is possible that the loss of glycemic control may be related to instability of insulin in the pump/line. In addition to premeal loss of control after 48 hours of line change, very little is known about post-prandial hyperglycemia leading to loss of efficacy of the insulin via an insulin pump bolus. The development of continuous glucose monitoring system (CGMS) and new tests for short term fluctuations in glucose control such as 1,5-anhydroglucitol make it easier to evaluate the impact of short term loss of control in patients using the insulin pump who delay changing their lines.

The different variables will be compared between the two insulins using a paired t test.

  1. Glycemic control will be will be compared 24 to 100 hours after pump infusion line change using CGMS and daily serum 1,5-anhydroglucitol.
  2. Post prandial glycemic excursions in plasma glucose following a standardized breakfast 48, 72, and 96 hours after a pump infusion line change will be compared.
  3. The used pump infusion line will be collected from the patient and analyzed for insulin binding to the plastic, as well as other possible effects that may determine its role in loss of glycemic control.
  4. Comparison of some of the markers of coagulation, inflammation, protein glycation and oxidative stress 48, 72, and 96 hours after a pump infusion line change.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 Diabetes treated with a pump for at least 3 months

Exclusion Criteria:

  • Pregnancy
  • Plasma Creatinine > 1.2 mg/dl
  • Inability to give informed consent
  • HbA1c > 8%
  • Known or suspected hypersensitivity to trial drugs or any of their components
  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: NCT00461331

Locations
United States, Louisiana
General Clinical Research Center
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University Health Sciences Center
Investigators
Principal Investigator: Vivian A Fonseca, MD, FRCP Tulane Universtiy Health Sciences Center
  More Information

No publications provided

Responsible Party: Vivian Fonseca, MD, Tulane University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00461331     History of Changes
Other Study ID Numbers: F-0215
Study First Received: April 16, 2007
Results First Received: May 12, 2009
Last Updated: April 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Tulane University Health Sciences Center:
Type 1 diabetes mellitus
Glycemic control
Continuous subcutaneous insulin infusion
Continuous glucose monitoring system

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

ClinicalTrials.gov processed this record on September 18, 2014