Clinical Trials Directory

Trials / Completed

CompletedNCT04020445

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

Status
Completed
Phase
Study type
Observational
Enrollment
150 (actual)
Sponsor
Bekes County Central Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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).

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.

Conditions

Interventions

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

Timeline

Start date
2016-01-01
Primary completion
2022-01-01
Completion
2022-01-01
First posted
2019-07-16
Last updated
2023-02-13

Locations

1 site across 1 country: Hungary

Source: ClinicalTrials.gov record NCT04020445. Inclusion in this directory is not an endorsement.