NCT07093476

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P25-P50 for phase_3

Timeline
11mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
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

Study Progress47%
Jul 2025Apr 2027

First Submitted

Initial submission to the registry

June 30, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

July 18, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

June 30, 2025

Last Update Submit

August 7, 2025

Conditions

T2DMDiabete Type 2DM

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Change from Baseline in HbA1c

    Week 24 of the Treatment

Study Arms (3)

Study group 1

ACTIVE COMPARATOR

Metformin + Alogliptin + Empagliflozin Xmg

Drug: MetforminDrug: AlogliptinDrug: empagliflozin

Study group 2

ACTIVE COMPARATOR

Metformin + Alogliptin + Empagliflozin Ymg

Drug: MetforminDrug: AlogliptinDrug: empagliflozin

Control Group

PLACEBO COMPARATOR

Metformin + Alogliptin

Drug: MetforminDrug: Alogliptin

Interventions

MetforminDRUG

tablets, QD, oral administration

Control GroupStudy group 1Study group 2
AlogliptinDRUG

tablets, QD, oral administration

Control GroupStudy group 1Study group 2
empagliflozinDRUG

tablets, QD, oral administration

Study group 1Study group 2

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

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metforminalogliptinempagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Celltrion, Inc.

CONTACT

+82 3403 9647sanghee.byun@celltrion.com

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

June 30, 2025

First Posted

July 30, 2025

Study Start

July 18, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations

KR(1)