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

NCT04020445 | Completed

• 1 other identifier: BekesCCH
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

HBA1c; Body Weight; Hypoglycemia

Keywords

iDegLira; deintensification; overtreatment; simplification; type 2 diabetes

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

de-escalation of complex insulin regimens OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Well-controlled or overtreated adult type 2 diabetic patients using relatively low dose MDI.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bekes County Central Hospital: lead
• University of Debrecen: collaborator
• Szeged University: collaborator

Study Sites (1)

Zoltán Taybani

Békéscsaba, Bekes County, 5600, Hungary

Location

Related 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.

  PMID: 31347100 RESULT

MeSH Terms

Conditions

Body Weight; Hypoglycemia; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Zoltán J Taybani, MD

  Bekes County Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 16, 2019
• Study Start: January 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

HU (1)