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

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
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07093476
Enrollment
171
Registered
2025-07-30
Start date
2025-07-18
Completion date
2027-04-30
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Type 2, DM, T2DM

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.

Interventions

DRUGMetformin

tablets, QD, oral administration

DRUGAlogliptin

tablets, QD, oral administration

DRUGempagliflozin

tablets, QD, oral administration

Sponsors

Celltrion
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HbA1cWeek 24 of the TreatmentChange from Baseline in HbA1c

Countries

South Korea

Contacts

Primary ContactCelltrion, Inc.
sanghee.byun@celltrion.com+82 3403 9647

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026