Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes

February 10, 2023 updated by: Zoltán Taybani, Bekes County Central Hospital
This study examines prospectively the safety and efficacy of switching from multiple daily insulin injections (MDI) to once daily IDegLira (insulin degludec and liraglutide fix ratio combination), a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c<7.5%) subjects with type 2 diabetes using low total daily insulin dose (TDD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Type 2 diabetic patients suffering from severe hyperglycemia are often apply multiple daily insulin injections (MDI). If glucose toxicity resolves, the regimen may potentially be simplified, but there are no specific guidelines regarding this and a lot of patients are left on MDI.

The Investigators aimed to examine prospectively the safety and efficacy of switching from MDI to once daily IDegLira, a fixed-ratio combination of insulin degludec and liraglutide, in relatively well controlled (HbA1c<7.5%) subjects with type 2 diabetes using low total daily insulin dose (TDD).

The investigators hypothesize that in everyday clinical practice switching from low dose MDI to IDegLira in patients of different ages with well-controlled (or overcontrolled) type 2 diabetes is safe, may induce weight loss and result in similar or better glycemic control.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Békés
      • Békéscsaba, Békés, Hungary, 5600
        • Zoltán Taybani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Well-controlled or overtreated adult type 2 diabetic patients using relatively low dose MDI.

Description

Inclusion Criteria:

  • Type 2 diabetic (T2D) patients >18 years old
  • detectable random, non-fasting serum C-peptide levels
  • HbA1c=< 7.5%
  • treated with MDI (with stable daily doses of insulin at least for 90 days prior to baseline visit)
  • using relatively low total daily insulin dose (TDD), at baseline visit low TDD is defined as TDD<70 IU/day and TDD<0.6 IU/kg/day at the same time.

Exclusion Criteria:

  • Type 1 diabetes
  • treatment of T2D with any medication for diabetes other than insulin or metformin during 90 days before baseline visit
  • active cancer
  • anaemia (haemoglobin <100g/l)
  • acute or chronic kidney disease with an estimated glomerular filtration rate <30 mL/min/1.73 m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants reaching HbA1c<7% and HbA1c<6.5%
Time Frame: it is checked at baseline and at 3, 6, 9 and 12 months
HbA1c is measuerd by laboratory blood test
it is checked at baseline and at 3, 6, 9 and 12 months
change in body weight from baseline to 3, 6, 9 and 12 months
Time Frame: it is checked at baseline and at 3, 6, 9 and 12 months
body weight is measured at the diabetes ambulance
it is checked at baseline and at 3, 6, 9 and 12 months
change in risk of hypoglycemia from baseline to 3, 6, 9 and 12 months
Time Frame: it is checked at baseline and at 3, 6, 9 and 12 months
hypoglycemia risk is assessed by analysing the patients' diary
it is checked at baseline and at 3, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bekes County Central Hospital

Collaborators

Szeged University
University of Debrecen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

January 1, 2022

Study Completion (ACTUAL)

January 1, 2022

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (ACTUAL)

July 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BekesCCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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