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Switch From U-100 Insulin Analog to U-500 Regular Insulin in Pumps for Type 2 Diabetes

Sponsor
University Hospital, Caen (Other)
Overall Status
Completed
CT.gov ID
NCT04371497
Collaborator
(none)
65
Enrollment
103
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The aim of the study was to perform a 3-year retrospective analysis from a cohort of patients with type 2 diabetes that were treated by a pump device and were uncontrolled despite high U-100 insulin requirements. The study reports outcomes after the switch from U-100 U/ml Rapid-Acting Analog to U-500 U/ml Regular Insulin, both administered by Continuous Subcutaneous Infusion.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study is a retrospective evaluation of a cohort of patients with Type 2 Diabetes from six French centers, who were previously treated by insulin pump therapy, and then switched from U-100 Rapid Acting Insulin analog to 500 U/mL Regular Insulin (Eli Lilly Inc, France) between June 2011 and September 2017. All participants had been previously treated by Multiple Daily Insulin injections and then had been treated by Continuous Subcutaneous Insulin Infusion with U-100 Rapid Acting Insulin analog administered by an insulin pump. Patient's selection criteria included an insulin-resistant state defined by a Total Daily insulin Dose greater than 100 U per day, and a switch from U-100 Rapid Acting Insulin analog to 500 U/mL Regular Insulin during the study period. Data collection from patient medical records included HbA1c, lipid levels, weight, Total Daily insulin Dose, and the recordings of hypoglycemia episodes. Outcomes were recorded at different timelines including baseline and 6, 12, 24 and 36-months after the switch from U-100 to U-500 insulin. Blinded continuous glucose monitoring (CGM) (ipro2, Medtronic Inc., USA) was analyzed in a subgroup of patients having CGM data available at baseline on U-100 insulin and after 6-months on U-500 insulin.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    65 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Three-year Retrospective Study on the Switch From Rapid-acting Insulin Analog to Concentrated U-500 Regular Insulin in Insulin-resistant Type 2 Diabetes Patients Treated by Pump Therapy
    Actual Study Start Date :
    Jun 1, 2011
    Actual Primary Completion Date :
    Sep 30, 2017
    Actual Study Completion Date :
    Dec 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. differential HbA1c before and after insulin switch [baseline, 1-year, 2-years, 3-years]

      HbA1c comparison between baseline and 1, 2, 3 year(s) after the switch to U-HbA1c comparison between baseline and 1, 2, 3 year(s) after the switch to U-500 insulin

    Secondary Outcome Measures

    1. Total Daily Insulin Dose [baseline, 1-year, 2-years, 3-years]

      Total Daily Insulin Dose at baseline and 1, 2, 3 year(s) after the switch to U-500 insulin

    2. Body Weight [baseline, 1-year, 2-years, 3-years]

      Body Weight measured at baseline and 1, 2, 3 year(s) after the switch to U-500

    3. Lipids [baseline, 1-year, 2-years, 3-years]

      Plasma Lipids measured at baseline and 1, 2, 3 year(s) after the switch to U-500

    4. Hypoglycemia events [baseline, 1-year, 2-years, 3-years]

      Episodes of Hypoglycemia recorded before and during the study

    5. Continuous Glucose Monitoring before and after insulin switch [baseline, 6-month]

      Continuous Glucose Monitoring comparison between baseline and 6-month after the switch to U-500

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • T2D diabetes

    • Pump therapy with U-100 U/ml rapid-acting analog prior to initiation of U-500 U/ml insulin

    • Total daily Insulin dose > 100 U per day

    Exclusion Criteria:
    • follow up < 3 months

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT04371497
    Other Study ID Numbers:
    • CHU 20-504
    First Posted:
    May 1, 2020
    Last Update Posted:
    May 1, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Caen
    Type 2 Diabetes
    Insulin Resistance
    Continuous Subcutaneous Insulin Infusion
    Insulin Pump
    Concentrated Insulin
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of May 1, 2020