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Type 2 Diabetes MellitusNCT04371497

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

An observational study of Type 2 Diabetes Mellitus, run by University Hospital, Caen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus
How many people
65 participants
Where
No sites listed yet
Study dates
1 Jun 2011to 30 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • follow up < 3 months

About this study

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

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.

Read the 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.

Keywords
Type 2 Diabetes, Insulin Resistance, Continuous Subcutaneous Insulin Infusion, Insulin Pump, Concentrated Insulin
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline, 1-year, 2-years, 3-years

Secondary outcomes (5)

  1. Total Daily Insulin Dose

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

    Measured: baseline, 1-year, 2-years, 3-years

  2. Body Weight

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

    Measured: baseline, 1-year, 2-years, 3-years

  3. Lipids

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

    Measured: baseline, 1-year, 2-years, 3-years

  4. Hypoglycemia events

    Episodes of Hypoglycemia recorded before and during the study

    Measured: baseline, 1-year, 2-years, 3-years

  5. Continuous Glucose Monitoring before and after insulin switch

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

    Measured: baseline, 6-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2020
  2. Study start1 Jun 2011
  3. Primary completion30 Sep 2017
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04371497
Sponsor's protocol ID
CHU 20-504
Status last verified
Apr 2020
First submitted
29 Apr 2020
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by University Hospital, Caen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

differential HbA1c before and after insulin switch (time frame: baseline, 1-year, 2-years, 3-years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04371497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.

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