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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371497
• Other study ID #: CHU 20-504
• Status: Completed
• Start date: June 1, 2011
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2020
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 30, 2019
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Outcome

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