Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin

NCT ID: NCT07093476

Last Updated: 2025-08-11

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

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-18

Study Completion Date

2027-04-30

Brief Summary

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Phase 3 study to assess the Efficacy and Safety of CT-L02-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Alogliptin Combination Therapy.

Detailed Description

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Conditions

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T2DM Diabete Type 2 DM

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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Study group 1

Metformin + Alogliptin + Empagliflozin Xmg

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

tablets, QD, oral administration

Alogliptin

Intervention Type DRUG

tablets, QD, oral administration

empagliflozin

Intervention Type DRUG

tablets, QD, oral administration

Study group 2

Metformin + Alogliptin + Empagliflozin Ymg

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

tablets, QD, oral administration

Alogliptin

Intervention Type DRUG

tablets, QD, oral administration

empagliflozin

Intervention Type DRUG

tablets, QD, oral administration

Control Group

Metformin + Alogliptin

Group Type PLACEBO_COMPARATOR

Metformin

Intervention Type DRUG

tablets, QD, oral administration

Alogliptin

Intervention Type DRUG

tablets, QD, oral administration

Interventions

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Metformin

tablets, QD, oral administration

Intervention Type DRUG

Alogliptin

tablets, QD, oral administration

Intervention Type DRUG

empagliflozin

tablets, QD, 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

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Celltrion, Inc.

Role: CONTACT

+82 3403 9647

Other Identifiers

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CT-L02-301

Identifier Type: -

Identifier Source: org_study_id

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