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

November 17, 2023 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

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • 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

  • Korea, Republic of
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, Korea, Republic of, 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

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
Intervention / Treatment
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

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

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 (Estimated)

November 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Estimated)

November 22, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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