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

N/ACompletedNCT04020445

Bekes County Central Hospital150 enrolled

Overview

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).

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

150

Conditions

HBA1c Body Weight Hypoglycemia

Interventions

de-escalation of complex insulin regimensOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Zoltán Taybani

Békéscsaba, Bekes County, Hungary

Outcomes

Primary Outcomes

Number of participants reaching HbA1c<7% and HbA1c<6.5%

HbA1c is measuerd by laboratory blood test

Time frame: 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

body weight is measured at the diabetes ambulance

Time frame: 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

hypoglycemia risk is assessed by analysing the patients' diary

Time frame: it is checked at baseline and at 3, 6, 9 and 12 months

Data from ClinicalTrials.gov

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