Body Weight, HBA1c, Hypoglycemia
Conditions
Keywords
iDegLira, deintensification, overtreatment, simplification, type 2 diabetes
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.
Interventions
OTHERde-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
Sponsors
University of Debrecen
Szeged University
Bekes County Central Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants reaching HbA1c<7% and HbA1c<6.5% | it is checked at baseline and at 3, 6, 9 and 12 months | HbA1c is measuerd by laboratory blood test |
| change in body weight from baseline to 3, 6, 9 and 12 months | it is checked at baseline and at 3, 6, 9 and 12 months | body weight is measured at the diabetes ambulance |
| change in risk of hypoglycemia from baseline to 3, 6, 9 and 12 months | it is checked at baseline and at 3, 6, 9 and 12 months | hypoglycemia risk is assessed by analysing the patients' diary |
Countries
Hungary
Outcome results
None listed