T2DMPhase 3NCT07093476
Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin
A Phase 3 study testing Metformin, Alogliptin and empagliflozin in people with T2DM and Diabete Type 2, run by Celltrion at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- T2DM, Diabete Type 2, DM
- What is being tested?
- Metformin, Alogliptin and empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jul 2025to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- T2DM, Diabete Type 2, DM
- Being tested
- Metformin, Alogliptin, empagliflozin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
tablets, QD, oral administration
AlogliptinDrug
tablets, QD, oral administration
empagliflozinDrug
tablets, QD, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Active comparator | Metformin + Alogliptin + Empagliflozin Xmg Receives: Drug: Metformin; Drug: Alogliptin; Drug: empagliflozin |
| Study group 2 | Active comparator | Metformin + Alogliptin + Empagliflozin Ymg Receives: Drug: Metformin; Drug: Alogliptin; Drug: empagliflozin |
| Control Group | Placebo comparator | Metformin + Alogliptin Receives: Drug: Metformin; Drug: Alogliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change from Baseline in HbA1c
Measured: Week 24 of the Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start18 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093476
- Sponsor's protocol ID
- CT-L02-301
- Status last verified
- Aug 2025
- First submitted
- 30 Jun 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07093476
- Acronym / sponsor ID
- CT-L02-301
- Conditions
- T2DM, Diabete Type 2, DM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | Active comparator | Drug: Metformin, Drug: Alogliptin, Drug: empagliflozinMetformin + Alogliptin + Empagliflozin Xmg |
| Study group 2 | Active comparator | Drug: Metformin, Drug: Alogliptin, Drug: empagliflozinMetformin + Alogliptin + Empagliflozin Ymg |
| Control Group | Placebo comparator | Drug: Metformin, Drug: AlogliptinMetformin + Alogliptin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformintablets, QD, oral administration | Drug | Control Group, Study group 1, Study group 2 |
| Alogliptintablets, QD, oral administration | Drug | Control Group, Study group 1, Study group 2 |
| empagliflozintablets, QD, oral administration | Drug | Study group 1, Study group 2 |
Primary outcome
HbA1c
Time frame: Week 24 of the Treatment
Change from Baseline in HbA1c
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin, Alogliptin and empagliflozin in people with T2DM and Diabete Type 2, run by Celltrion at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celltrion, Inc. (+82 3403 9647, sanghee.byun@celltrion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Week 24 of the Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.