---
title: Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes
nct_id: NCT04020445
overall_status: COMPLETED
sponsor: Bekes County Central Hospital
study_type: OBSERVATIONAL
primary_condition: HBA1c
countries: Hungary
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04020445.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04020445"
ct_last_update_post_date: 2023-02-13
last_seen_at: "2026-05-12T06:26:07.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes

**NCT ID:** [NCT04020445](https://clinicaltrials.gov/study/NCT04020445)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 150
- **Lead Sponsor:** Bekes County Central Hospital
- **Collaborators:** University of Debrecen, Szeged University
- **Conditions:** HBA1c, Body Weight, Hypoglycemia
- **Start Date:** 2016-01-01
- **Completion Date:** 2022-01-01
- **CT.gov Last Update:** 2023-02-13

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL

```
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
```

## 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

## Primary Outcomes

- **Number of participants reaching HbA1c<7% and HbA1c<6.5%** _(time frame: 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** _(time frame: 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** _(time frame: it is checked at baseline and at 3, 6, 9 and 12 months)_ — hypoglycemia risk is assessed by analysing the patients' diary

## Locations (1)

- Zoltán Taybani, Békéscsaba, Bekes County, Hungary

## Recent Field Changes (last 30 days)

- `locations.zoltán taybani|békéscsaba|bekes county|hungary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04020445.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04020445*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*