Efficacy and Safety of Add-On Therapy With Empagliflozin... | NCT07093476

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

NCT07093476

Sponsor

Celltrion

Status

Recruiting

Last Update Posted

Aug 11, 2025Actual

Enrollment

171Estimated

Phase

Phase 3

Conditions

T2DM
Diabete Type 2
DM

Interventions

Metformin
Alogliptin
empagliflozin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trial and Open-Label Extension Study to Evaluate the Efficacy and Safety of Add-On Therapy With Empagliflozin for Patients With Inadequately Controlled Type 2 DiabetesMellitus in the Combination Treatment With Metformin and Alogliptin

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 18, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Jun 30, 2025

First Submission Date that Met QC Criteria

Jul 23, 2025

First Posted Date

Jul 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2025

Last Update Posted Date

Aug 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

171Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group 1	Active Comparator	Metformin + Alogliptin + Empagliflozin Xmg	Drug: Metformin Drug: Alogliptin Drug: empagliflozin
Study group 2	Active Comparator	Metformin + Alogliptin + Empagliflozin Ymg	Drug: Metformin Drug: Alogliptin Drug: empagliflozin
Control Group	Placebo Comparator	Metformin + Alogliptin	Drug: Metformin Drug: Alogliptin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	tablets, QD, oral administration	Control Group Study group 1 Study group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c	Change from Baseline in HbA1c	Week 24 of the Treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Celltrion, Inc.	Contact	+82 3403 9647		sanghee.byun@celltrion.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Celltrion	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin
C520853	alogliptin
C570240	empagliflozin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided