Type 2 Diabetes MellitusPhase 2NCT06144788
Evaluation of Efficacy and Safety When Administered JP-2266 in Type 2 Diabetes Patients
A Phase 2 study testing SGLT2 inhibitor in people with Type 2 Diabetes Mellitus, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Therapeutic Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of JP-2266 in Patients with Type 2 Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- SGLT2 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Nov 2023to 23 Dec 2024
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged 19 to 80 years
- Those diagnosed with type 2 diabetes
- A person who provides diet and exercise therapy for the management of diabetes from 8 weeks before the screening criteria and can continue diet and exercise therapy during the clinical trial
- Screening Results of the following criteria
- 7% ≤ HbA1c ≤ 10%
- FPG ≤ 270 mg/dL
- Patients with 20 < BMI ≤ 45 kg/㎡
- Those who voluntarily signed the informed consent to participate in this study
Who cannot join
- Any type of diabetes other than type 2 diabetes
- Screening when the inspection meets the following criteria
- AST or ALT more than 3 times the normal upper limit
- Total bilirubin exceeds twice the normal upper limit
- eGFR < 60 mL/min/1.73㎡
- A person with the following medical history or history of surgery/therapy
Show all 31Show fewer
- Medically significant history of kidney disease: kidney vascular obstruction disease, nephrectomy, kidney transplantation, etc
- History of severe gastrointestinal surgery: total gastrectomy, total colon resection, small intestine resection, gastrointestinal anastomosis, gastrointestinal bypass, etc
- history of acute pancreatitis or pancreatic surgery
- History of undergoing bariatric surgery within 2 years before screening
- Diabetic ketoacidosis, diabetic coma or whole marriage within 1 year prior to screening
- Urinary tract infections or genital infections within 1 year prior to screening
- Alcohol or drug addiction within 1 year prior to screening
- A history of severe heart disease (heart failure, unstable angina, myocardial infarction, congestive heart failure symptoms
- A person who has a history of significant surgery that causes electrolyte imbalance within 12 weeks before screening, or who is scheduled to undergo significant surgery within 12 weeks after the end of the clinical trial
- Hypertension emergency medical history within 12 weeks prior to screening
- There is a weight change of more than 10% within 12 weeks prior to screening, and symptoms of polyuria and bipolar disorder
- A person with a history of malignancy within 5 years prior to screening However, a complete cure or properly controlled basal cell cancer, squamous cell skin cancer, or cervical intraepithelial cancer is allowed, but the history of bladder cancer cannot participate even if it has been more than 5 years
- A person who has the following diseases or signs
- Dysuria that is not medically controlled due to tense urinary incontinence, neurotic bladder, prostate hypertrophy, or symptoms of anuria, oliguria, urinary retention
- Severe diabetic complications (proliferative diabetic retinopathy, nephropathy above stage 4 or severe diabetic neuropathy)
- Chronic diseases that require continuous use of diuretics, systemic steroids or immunosuppressants (alveolar administration, injection)
- Active liver disease, hepatitis, liver failure or cirrhosis
- Patients with pituitary or adrenal insufficiency
- Severe infections requiring the use of persistent antibiotics or immunotherapy drugs, and significant clinically trauma
- an unstable mental illness that is not medically controlled
- Severe gastrointestinal diseases: active ulcers, gastrointestinal/intestinal bleeding, active inflammatory bowel syndrome, patients with biliary obstruction, active gastritis not controlled by medication, etc
- A person who has a history of hypersensitivity to the ingredients of a clinical trial drug, SGLT1/SGLT2 inhibitor or SGLT-2 inhibitor
- Pregnant or lactating women
- Participants in interventional clinical trials subject to other IP or medical devices within 12 weeks prior to screening
- If the investigator is deemed unsuitable for the subject of this clinical trial due to other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Therapeutic Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of JP-2266 in Patients With Type 2 Diabetes Mellitus
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Therapeutic Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of JP-2266 in Patients with Type 2 Diabetes Mellitus
Read the detailed description
Evaluation of efficacy and safety when administered JP-2266 in type 2 diabetes patients
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- SGLT2 inhibitor
- 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.
SGLT2 inhibitorDrug
Also called SGLT 1/2 dual inhibitor
SGLT 1/2 dual inhibitor
| Study group | Role | What they receive |
|---|---|---|
| JP-2266 Low-dose | Experimental | Subjects take the investigational products once a day for 12 weeks. Receives: Drug: SGLT2 inhibitor |
| JP-2266 High-dose | Experimental | Subjects take the investigational products once a day for 12 weeks. Receives: Drug: SGLT2 inhibitor |
| placebo | Experimental | Subjects take the investigational products once a day for 12 weeks. Receives: Drug: SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1c at the 12 week from the baseline
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start3 Nov 2023
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 161 participants (actual)
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
- NCT06144788
- Sponsor's protocol ID
- JP-2266-201
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee EY, Han KA, Kwak SH, Hong JH, Hwang YC, Koh G, Hughes JW, Kim S, Lee CS, Cha BS. Efficacy and Safety of the Dual SGLT1 and SGLT2 Inhibitor JP-2266 in Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study. Diabetes Metab J. 2026 Jul 29. doi: 10.4093/dmj.2025.1152. Online ahead of print.
PubMed 42522372
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Therapeutic Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of JP-2266 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06144788
- Acronym / sponsor ID
- JP-2266-201
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 22 Nov 2023 (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 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Therapeutic Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of JP-2266 in Patients with Type 2 Diabetes Mellitus
Detailed description
Evaluation of efficacy and safety when administered JP-2266 in type 2 diabetes patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JP-2266 Low-dose | Experimental | Drug: SGLT2 inhibitorSubjects take the investigational products once a day for 12 weeks. |
| JP-2266 High-dose | Experimental | Drug: SGLT2 inhibitorSubjects take the investigational products once a day for 12 weeks. |
| placebo | Experimental | Drug: SGLT2 inhibitorSubjects take the investigational products once a day for 12 weeks. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult aged 19 to 80 years
- Those diagnosed with type 2 diabetes
- A person who provides diet and exercise therapy for the management of diabetes from 8 weeks before the screening criteria and can continue diet and exercise therapy during the clinical trial
- Screening Results of the following criteria
- Patients with 20 < BMI ≤ 45 kg/㎡
Key exclusion criteria (31 listed)
- Any type of diabetes other than type 2 diabetes
- Screening when the inspection meets the following criteria
- A person with the following medical history or history of surgery/therapy
- A person who has the following diseases or signs
- A person who has a history of hypersensitivity to the ingredients of a clinical trial drug, SGLT1/SGLT2 inhibitor or SGLT-2 inhibitor
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 |
|---|---|---|
| SGLT2 inhibitorAlso: SGLT 1/2 dual inhibitorSGLT 1/2 dual inhibitor | Drug | JP-2266 High-dose, JP-2266 Low-dose, placebo |
Primary outcome
Changes in HbA1c at the 12 week from the baseline
Time frame: 12 week
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 7 Jul 2026.
- Derived from this study: PubMed 42522372Lee EY, Han KA, Kwak SH, Hong JH, Hwang YC, Koh G, Hughes JW, Kim S, Lee CS, Cha BS. Efficacy and Safety of the Dual SGLT1 and SGLT2 Inhibitor JP-2266 in Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study. Diabetes Metab J. 2026 Jul 29. doi: 10.4093/dmj.2025.1152. Online ahead of print.
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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.
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 2 study testing SGLT2 inhibitor 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 8 inclusion and 31 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 7 Jul 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in HbA1c at the 12 week from the baseline (time frame: 12 week). 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 NCT06144788, 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 7 Jul 2026.