---
title: Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy
nct_id: NCT05103306
overall_status: UNKNOWN
sponsor: Chungbuk National University Hospital
study_type: OBSERVATIONAL
primary_condition: Diabetes Mellitus, Type 2
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05103306.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05103306"
ct_last_update_post_date: 2022-07-20
last_seen_at: "2026-05-12T07:28:17.815Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy

**Official Title:** Long-term Effectiveness and Safety of Empagliflozin-based Quadruple Oral Antidiabetic Agents Therapy Compared to Basal Insulin-based Combination Therapy in Patients With Type 2 Diabetes

**NCT ID:** [NCT05103306](https://clinicaltrials.gov/study/NCT05103306)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 300
- **Lead Sponsor:** Chungbuk National University Hospital
- **Conditions:** Diabetes Mellitus, Type 2
- **Start Date:** 2017-01
- **Completion Date:** 2022-12
- **CT.gov Last Update:** 2022-07-20

## Brief Summary

This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.

## Detailed Description

This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Inadequately controlled with triple OADs (metformin, glimepiride, dipeptidyl peptidase-4 inhibitor) showing HbA1c 7.5-12.0%

Exclusion Criteria:

* Type 1 diabetes
* Gestional diabetes
* Diabetes due to secondary causes
* Receiving anticancer treatment
* Receiving glucocorticoids or immune-suppressants
* Have been treated with sodium glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering the study
* Have been treated with any type of insulin for more than 7 consecutive days within 3 months before entering the study
```

## Arms

- **Triple OADs failure** — Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor

## Interventions

- **Empagliflozin 25 MG** (DRUG) — Empagliflozin 25mg/day add-on to triple combination oral antidiabetic agents consisted with metformin, glimepiride, and DPP4 inhibitor
- **INS** (DRUG) — Basal insulin add on the background OADs

## Primary Outcomes

- **Changes in HbA1c From Baseline to months 36** _(time frame: Baseline, month 36 (3-year))_ — Changes in HbA1c From Baseline to months 36 (3-year)

## Secondary Outcomes

- **Achievement of target HbA1c** _(time frame: Baseline, month 36)_
- **Changes in HbA1c** _(time frame: Baseline, month 3, 6, 12, 18, 24, 30)_
- **Changes in FPG** _(time frame: Baseline, month 3, 6, 12, 18, 24, 30, 36)_
- **Changes in lipid profiles** _(time frame: Baseline, month 36)_
- **Changes in body weight** _(time frame: Baseline, month 36)_
- **Changes in blood pressure** _(time frame: Baseline, month 36)_
- **Percentage of patients with hypoglycemic episodes** _(time frame: Baseline, month 36)_
- **Percentage of patients with at least 1 episode of genitourinary tract infections** _(time frame: Baseline, month 36)_

## Recent Field Changes (last 30 days)

- `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.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05103306.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05103306*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*