NCT06571591

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
582

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 27, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

August 19, 2024

Last Update Submit

November 16, 2025

Conditions

T2DM

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Change from Baseline in HbA1c

    Week 24 of the Treatment

Secondary Outcomes (3)

  • HbA1c

    Week 12 of the Treatment

  • FPG

    Week 12 and 24 of the Treatment

  • Body weight

    Week 12 and 24 of the Treatment

Study Arms (3)

Group 1

ACTIVE COMPARATOR
Drug: CT-L03 Group 1Drug: EmpagliflozinDrug: Metformin

Group 2

ACTIVE COMPARATOR
Drug: CT-L03 Group 2Drug: EmpagliflozinDrug: Metformin

Placebo

PLACEBO COMPARATOR
Drug: PlaceboDrug: EmpagliflozinDrug: Metformin

Interventions

CT-L03 Group 1DRUG

tablets, QD, oral administration

Group 1
CT-L03 Group 2DRUG

tablets, QD, oral administration

Group 2
PlaceboDRUG

tablets, QD, oral administration

Placebo
EmpagliflozinDRUG

tablet, QD, oral administration

Group 1Group 2Placebo
MetforminDRUG

tablets, oral administration

Group 1Group 2Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celltrion

Incheon, South Korea

Location

MeSH Terms

Interventions

empagliflozinMetformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 26, 2024

Study Start

August 27, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations

KR(1)