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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04020445
Other study ID # BekesCCH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date January 1, 2022

Study information

Verified date February 2023
Source Bekes County Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
de-escalation of complex insulin regimens
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

Locations

Country Name City State
Hungary Zoltán Taybani Békéscsaba Békés

Sponsors (3)

Lead Sponsor Collaborator
Bekes County Central Hospital Szeged University, University of Debrecen

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

Taybani Z, Botyik B, Katko M, Gyimesi A, Varkonyi T. Simplifying Complex Insulin Regimens While Preserving Good Glycemic Control in Type 2 Diabetes. Diabetes Ther. 2019 Oct;10(5):1869-1878. doi: 10.1007/s13300-019-0673-8. Epub 2019 Jul 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants reaching HbA1c<7% and HbA1c<6.5% HbA1c is measuerd by laboratory blood test it is checked at baseline and at 3, 6, 9 and 12 months
Primary change in body weight from baseline to 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
Primary change in risk of hypoglycemia from baseline to 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
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