Efficacy and Safety of Pioglitazone Combination Therapy i... | NCT06571591

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

NCT06571591

Sponsor

Celltrion

Status

Completed

Last Update Posted

May 15, 2026Actual

Enrollment

606Actual

Phase

Phase 3

Conditions

T2DM

Interventions

CT-L03 Group 1
CT-L03 Group 2
Placebo
Empagliflozin
Metformin

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

ID	Type	Description	Link
CT-L03	Other Identifier	celltrion Inc.

Official Title

A Multicentre, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Pioglitazone Co-administration in Patients With Type II Diabetes With Insufficient Glycemic Control With Metformin and Empagliflozin Combination Therapy

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 27, 2024Actual

Primary Completion Date

Apr 16, 2026Actual

Completion Date

May 4, 2026Actual

First Submitted Date

Aug 19, 2024

First Submission Date that Met QC Criteria

Aug 23, 2024

First Posted Date

Aug 26, 2024Actual

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

May 13, 2026

Last Update Posted Date

May 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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-L03-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Empagliflozin 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

606Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group 1	Active Comparator	Drug: CT-L03 Group 1 Drug: Empagliflozin Drug: Metformin
Group 2	Active Comparator	Drug: CT-L03 Group 2 Drug: Empagliflozin Drug: Metformin
Placebo	Placebo Comparator	Drug: Placebo Drug: Empagliflozin Drug: Metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT-L03 Group 1	Drug	tablets, QD, oral administration	Group 1
CT-L03 Group 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
HbA1c	Change from Baseline in HbA1c	Week 12 of the Treatment
FPG	Change from Baseline in fasting plasma glucose	Week 12 and 24 of the Treatment

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

Intervention Browse Module

MeSH Terms

ID	Term
C570240	empagliflozin
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided