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Completed

NCT Number: NCT04020445

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zoltán Taybani

Békéscsaba, Bekes County, 5600, Hungary

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

de-escalation of complex insulin regimens

Other

complex insulin regimens are switched to fix ratio combinations consisting of of a basal insulin and a GLP-1 (glucagon-like peptide-1) receptor agonist

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Bekes County Central Hospital

Other

Collaborators

  • Szeged University
  • University of Debrecen

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2019
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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