Clinical trial NCT04020445: Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes
Official title: Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HBA1c
Body Weight
Hypoglycemia
Keywords: iDegLira
deintensification
overtreatment
simplification
type 2 diabetes
Lead sponsor: Bekes County Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Debrecen
name: Szeged University
First posted: 2019-07-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Well-controlled or overtreated adult type 2 diabetic patients using relatively low dose MDI.

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.

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

Primary outcomes:
measure: Number of participants reaching HbA1c<7% and HbA1c<6.5%
timeFrame: it is checked at baseline and at 3, 6, 9 and 12 months
measure: change in body weight from baseline to 3, 6, 9 and 12 months
timeFrame: it is checked at baseline and at 3, 6, 9 and 12 months
measure: change in risk of hypoglycemia from baseline to 3, 6, 9 and 12 months
timeFrame: it is checked at baseline and at 3, 6, 9 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Békéscsaba
country: Hungary
facility: Zoltán Taybani
state: Békés
Study officials:
affiliation: Bekes County Central Hospital
name: Zoltán J Taybani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.