Evaluation of Efficacy and Safety When Administered JP-2266 in Type 2 Diabetes Patients

July 5, 2026 updated by: Jeil Pharmaceutical Co., Ltd.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Evaluation of efficacy and safety when administered JP-2266 in type 2 diabetes patients

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, South Korea, 03722
        • Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult aged 19 to 80 years
  2. Those diagnosed with type 2 diabetes
  3. 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

  4. Screening Results of the following criteria

    • 7% ≤ HbA1c ≤ 10%
    • FPG ≤ 270 mg/dL
  5. Patients with 20 < BMI ≤ 45 kg/㎡
  6. Those who voluntarily signed the informed consent to participate in this study

Exclusion Criteria:

  1. Any type of diabetes other than type 2 diabetes

  2. 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㎡

  3. A person with the following medical history or history of surgery/therapy

    • 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

  4. 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
  5. A person who has a history of hypersensitivity to the ingredients of a clinical trial drug, SGLT1/SGLT2 inhibitor or SGLT-2 inhibitor
  6. Pregnant or lactating women
  7. Participants in interventional clinical trials subject to other IP or medical devices within 12 weeks prior to screening
  8. If the investigator is deemed unsuitable for the subject of this clinical trial due to other reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JP-2266 Low-dose
Subjects take the investigational products once a day for 12 weeks.
Drug: SGLT2 inhibitor
SGLT 1/2 dual inhibitor
Other Names:
  • SGLT 1/2 dual inhibitor
Experimental: JP-2266 High-dose
Subjects take the investigational products once a day for 12 weeks.
Drug: SGLT2 inhibitor
SGLT 1/2 dual inhibitor
Other Names:
  • SGLT 1/2 dual inhibitor
Experimental: placebo
Subjects take the investigational products once a day for 12 weeks.
Drug: SGLT2 inhibitor
SGLT 1/2 dual inhibitor
Other Names:
  • SGLT 1/2 dual inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes in HbA1c at the 12 week from the baseline
Time Frame: 12 week
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jeil Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JP-2266-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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