Type 2 Diabetes MellitusPhase 3NCT05296044
To Evaluate the Efficacy and Safety of JT-003 add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
A Phase 3 study testing JT-003 in people with Type 2 Diabetes Mellitus, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of JT-003 Add-on in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin and Dapagliflozin Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- JT-003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2022to 28 Feb 2024
- 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 aged 19 years or older with type 2 diabetes mellitus
- Subjects with 7.0% ≤ HbA1c ≤ 11% at baseline
- Those with > 45 kg/m2 of BMI
- Those who voluntarily signed the informed consent to participate in this study
Who cannot join
- Those who had allergic reaction to main ingredients or components of the investigational products.
- Patients with the following major systemic disease
- Patients with type 1 diabetes mellitus, secondary diabetes, or congenital renal diabetes etc.)
- Patients with pituitary insufficiency or adrenal dysfunction
- Patients with uncontrolled glycosemia(FPG > 270 mg/dL)
- Patients with uncontrolled hypertension(SBP > 180 mmHg or DBP > 110 mmHg
Show all 28Show fewer
- Patients with severe hypertriglyceridemia (Triglyceride > 500 mg/dL)
- Patients with severe renal dysfunction
- Patients with liver dysfunction
- Patients with AIDS
- Those with clinically significant severe infection or trauma based on an investigator's judgement
- Patients with pulmonary infarction, severe pulmonary dysfunction, hypoxemia
- Unstable mental illness not regulated by drugs
- Those who suffered from gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of investigational products or had underwent surgery;
- Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
- Those with a history of malignant tumor within 5 years
- Those with history of alcohol or drug abuse within 1 years
- Those with heart failure (NYHA class II~IV) or who had suffered from heart failure within 6 months
- Those who underwent surgery requiring general anesthesia within 4 weeks as of Visit 1 or who are scheduled to receive such surgery within 4 weeks after the study ends
- Those who need to take prohibited concomitant medications stated during the study period.
- Females who are pregnant or breastfeeding or patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
- Those who are judged unsuitable for the study by a principal investigator or investigators
- Those who have been administered with the following drugs or expected to require the continued administration during the study period:
- Those who have been administered with obesity drugs within 12 weeks
- Those being administered with thyroid medications and whose dose has been modified within 6 weeks
- Those administered with systemic steroid agents (Prednisolone, >30 mg/day) within 2 weeks
- Those being administered with diuretics and whose dose has been modified within 8 weeks as (however, dose reduction is accepted.)
- Those who are currently participating in other ongoing clinical studies or those who have taken the investigational products from other clinical studies within 12 weeks
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Kyung-Soo Park, MD., Ph.D
About this study
Official title: This Study Evaluates the Addition of Dapagliflozin in the Treatment of Type 2 Diates With Metformin and JT-003 Combination Therapy.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of JT-003 Add-on in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin and Dapagliflozin
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- JT-003, JT-003 Placebo
- 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.
JT-003Drug
Subjects take the investigational products once a day for 24 weeks.
JT-003 PlaceboDrug
Subjects take the investigational products once a day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| JT-003 | Experimental | Drug: JT-003 Receives: Drug: JT-003 |
| JT-003 Placebo | Placebo comparator | Drug: JT-003 Placebo Receives: Drug: JT-003 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1c
Changes in HbA1c at the 24 week from the baseline
Measured: 24 week from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start5 Apr 2022 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296044
- Sponsor's protocol ID
- JLP-2008-302
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hong JH, Han KA, Hwang YC, Hong EG, Kim HJ, Lee CB, Cho HC, Won JC, Kim HS, Kim EH, Koh G, Ahn KH, Park KS. Efficacy and Safety of High-Dose Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial. Diabetes Metab J. 2026 Mar;50(2):320-330. doi: 10.4093/dmj.2024.0696. Epub 2025 Oct 28.
PubMed 41151541
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study Evaluates the Addition of Dapagliflozin in the Treatment of Type 2 Diates With Metformin and JT-003 Combination Therapy.
- ClinicalTrials.gov ID
- NCT05296044
- Acronym / sponsor ID
- JLP-2008-302
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2022 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 25 Mar 2022 (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.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of JT-003 Add-on in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin and Dapagliflozin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JT-003 | Experimental | Drug: JT-003Drug: JT-003 |
| JT-003 Placebo | Placebo comparator | Drug: JT-003 PlaceboDrug: JT-003 Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 19 years or older with type 2 diabetes mellitus
- Subjects with 7.0% ≤ HbA1c ≤ 11% at baseline
- Those with > 45 kg/m2 of BMI
- Those who voluntarily signed the informed consent to participate in this study
Key exclusion criteria (28 listed)
- Those who had allergic reaction to main ingredients or components of the investigational products.
- Patients with the following major systemic disease
- Those with a history of malignant tumor within 5 years
- Those with history of alcohol or drug abuse within 1 years
- Those with heart failure (NYHA class II~IV) or who had suffered from heart failure within 6 months
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 |
|---|---|---|
| JT-003Subjects take the investigational products once a day for 24 weeks. | Drug | JT-003 |
| JT-003 PlaceboSubjects take the investigational products once a day for 24 weeks. | Drug | JT-003 Placebo |
Primary outcome
Changes in HbA1c
Time frame: 24 week from the baseline
Changes in HbA1c at the 24 week from the baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 41151541Hong JH, Han KA, Hwang YC, Hong EG, Kim HJ, Lee CB, Cho HC, Won JC, Kim HS, Kim EH, Koh G, Ahn KH, Park KS. Efficacy and Safety of High-Dose Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial. Diabetes Metab J. 2026 Mar;50(2):320-330. doi: 10.4093/dmj.2024.0696. Epub 2025 Oct 28.
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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. This study is not recruiting at the moment.
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 JT-003 in people with Type 2 Diabetes Mellitus, run by Jeil Pharmaceutical Co., Ltd. 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 4 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 25 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Soo Park, M.D. Ph.D (+82-2-2072-1673, kspark@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HbA1c (time frame: 24 week from the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05296044, which also lists 1 linked publication.
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 25 Mar 2022.