T2DMPhase 3CT-L03NCT06571591
Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin
A Phase 3 study testing CT-L03 Group 1, CT-L03 Group 2 and Empagliflozin in people with T2DM, run by Celltrion at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- T2DM
- What is being tested?
- CT-L03 Group 1, CT-L03 Group 2 and Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 606 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Aug 2024to 4 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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.
About this study
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
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.
- Conditions
- T2DM
- Being tested
- CT-L03 Group 1, CT-L03 Group 2, Placebo, Empagliflozin, Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-L03 Group 1Drug
tablets, QD, oral administration
CT-L03 Group 2Drug
tablets, QD, oral administration
PlaceboDrug
tablets, QD, oral administration
EmpagliflozinDrug
tablet, QD, oral administration
MetforminDrug
tablets, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Drug: CT-L03 Group 1; Drug: Empagliflozin; Drug: Metformin |
| Group 2 | Active comparator | Not described Receives: Drug: CT-L03 Group 2; Drug: Empagliflozin; Drug: Metformin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Empagliflozin; Drug: Metformin |
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
Secondary outcomes (3)
HbA1c
Change from Baseline in HbA1c
Measured: Week 12 of the Treatment
FPG
Change from Baseline in fasting plasma glucose
Measured: Week 12 and 24 of the Treatment
Body weight
Change from Baseline in body weight
Measured: Week 12 and 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 posted26 Aug 2024
- Study start27 Aug 2024
- Primary completion16 Apr 2026
- Study completion4 May 2026
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
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571591
- Sponsor's protocol ID
- CT-L03-301
- Other IDs
- CT-L03
- Acronym
- CT-L03
- Status last verified
- May 2026
- First submitted
- 19 Aug 2024
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06571591
- Acronym / sponsor ID
- CT-L03 / CT-L03-301
- Conditions
- T2DM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 26 Aug 2024 (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-L03-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Empagliflozin 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 |
|---|---|---|
| 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 |
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 |
|---|---|---|
| CT-L03 Group 1tablets, QD, oral administration | Drug | Group 1 |
| CT-L03 Group 2tablets, QD, oral administration | Drug | Group 2 |
| Placebotablets, QD, oral administration | Drug | Placebo |
| Empagliflozintablet, QD, oral administration | Drug | Group 1, Group 2, Placebo |
| Metformintablets, oral administration | Drug | Group 1, Group 2, Placebo |
Primary outcome
HbA1c
Time frame: Week 24 of the Treatment
Change from Baseline in HbA1c
3 secondary outcomes
HbA1c
Time frame: Week 12 of the Treatment
FPG
Time frame: Week 12 and 24 of the Treatment
Body weight
Time frame: Week 12 and 24 of the Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Related trials for T2DM
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 CT-L03 Group 1, CT-L03 Group 2 and Empagliflozin in people with T2DM, 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: finished, as of the sponsor's last update on 15 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 15 May 2026.