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

Bekes County Central Hospital

Status: Completed

Conditions: Hypoglycemia; HBA1c; Body Weight

Treatments: Other: de-escalation of complex insulin regimens

Study type: Observational

Funder types: Other

Identifiers

NCT04020445

BekesCCH

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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