Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin

NCT ID: NCT06571591

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

582 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-27

Study Completion Date

2026-05-31

Brief Summary

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Phase 3 study to assess the Efficacy and Safety of CT-L03-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Empagliflozin Combination Therapy.

Detailed Description

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Conditions

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T2DM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Group Type ACTIVE_COMPARATOR

CT-L03 Group 1

Intervention Type DRUG

tablets, QD, oral administration

Empagliflozin

Intervention Type DRUG

tablet, QD, oral administration

Metformin

Intervention Type DRUG

tablets, oral administration

Group 2

Group Type ACTIVE_COMPARATOR

CT-L03 Group 2

Intervention Type DRUG

tablets, QD, oral administration

Empagliflozin

Intervention Type DRUG

tablet, QD, oral administration

Metformin

Intervention Type DRUG

tablets, oral administration

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

tablets, QD, oral administration

Empagliflozin

Intervention Type DRUG

tablet, QD, oral administration

Metformin

Intervention Type DRUG

tablets, oral administration

Interventions

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CT-L03 Group 1

tablets, QD, oral administration

Intervention Type DRUG

CT-L03 Group 2

tablets, QD, oral administration

Intervention Type DRUG

Placebo

tablets, QD, oral administration

Intervention Type DRUG

Empagliflozin

tablet, QD, oral administration

Intervention Type DRUG

Metformin

tablets, oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults at the time of signing the Informed Consent Form (ICF)
* Signed the written ICF voluntarily after being fully informed of the objectives, methods, and effects of the study
* Diagnosed with T2DM

Exclusion Criteria

* Diagnosed with other types of diabetes than T2DM
* History of hypersensitivity reaction to the components or drugs of the same class as the IP or the background therapy
* Uncontrolled severe complications of diabetes
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celltrion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celltrion

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CT-L03

Identifier Type: OTHER

Identifier Source: secondary_id

CT-L03-301

Identifier Type: -

Identifier Source: org_study_id

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