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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04371497

Enrollment

Registered

2020-05-01

Start date

2011-06-01

Completion date

2019-12-30

Last updated

2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes, Insulin Resistance, Continuous Subcutaneous Insulin Infusion, Insulin Pump, Concentrated Insulin

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
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
Hypoglycemia events	baseline, 1-year, 2-years, 3-years	Episodes of Hypoglycemia recorded before and during the study
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

Outcome results