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

Completed

• Conditions: HBA1c; Hypoglycemia; Body Weight

• Registration Number: NCT04020445
• Lead Sponsor: Bekes County Central Hospital

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.

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-16
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zoltán Taybani; 🇭🇺 Békéscsaba, Békés, Hungary