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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus

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 Type: Observational
• Enrollment (Actual): 65

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Type 2 Diabetes, treated by pump therapy with U-100 U/ml rapid-acting analog, with a Total daily Insulin dose > 100 U per day, willing to switch to U-500 U/ml insulin administered by Pump

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
differential HbA1c before and after insulin switch	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	baseline, 1-year, 2-years, 3-years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Daily Insulin Dose	Total Daily Insulin Dose at baseline and 1, 2, 3 year(s) after the switch to U-500 insulin	baseline, 1-year, 2-years, 3-years
Body Weight	Body Weight measured at baseline and 1, 2, 3 year(s) after the switch to U-500	baseline, 1-year, 2-years, 3-years
Lipids	Plasma Lipids measured at baseline and 1, 2, 3 year(s) after the switch to U-500	baseline, 1-year, 2-years, 3-years
Hypoglycemia events	Episodes of Hypoglycemia recorded before and during the study	baseline, 1-year, 2-years, 3-years
Continuous Glucose Monitoring before and after insulin switch	Continuous Glucose Monitoring comparison between baseline and 6-month after the switch to U-500	baseline, 6-month

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2011
• Primary Completion (ACTUAL): September 30, 2017
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (ACTUAL): May 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Insulin Resistance; Type 2 Diabetes; Insulin Pump; Continuous Subcutaneous Insulin Infusion; Concentrated Insulin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CHU 20-504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No