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Completed

NCT Number: NCT04371497

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. differential HbA1c before and after insulin switch

    Time frame: 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 outcomes

  1. Total Daily Insulin Dose

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: baseline, 6-month

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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2017
Study completion
2019
First posted
May 1, 2020
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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