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

Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04020445
• Other study ID #: BekesCCH
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: January 1, 2022

Study information

• Verified date: February 2023
• Source: Bekes County Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus, Type 2
• HBA1c
• Hypoglycemia

Intervention

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

Locations

Country	Name	City	State
Hungary	Zoltán Taybani	Békéscsaba	Békés

Sponsors (3)

Lead Sponsor	Collaborator
Bekes County Central Hospital	Szeged University, University of Debrecen

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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