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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
HBA1c, Body Weight, Hypoglycemia

Intervention / Treatment
-----------------
* Other: de-escalation of complex insulin regimens


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iDegLira, deintensification, overtreatment, simplification, type 2 diabetes