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

Sponsor
Jeil Pharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06144788
Collaborator
(none)
156
Enrollment
1
Location
3
Arms
17
Anticipated Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: SGLT2 inhibitor
 Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
156 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Double blind
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in HbA1c at the 12 week from the baseline [12 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Patients with 20 < BMI ≤ 45 kg/㎡

    2. 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㎡

    1. 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

    1. 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

    1. A person who has a history of hypersensitivity to the ingredients of a clinical trial drug, SGLT1/SGLT2 inhibitor or SGLT-2 inhibitor

    2. Pregnant or lactating women

    3. Participants in interventional clinical trials subject to other IP or medical devices within 12 weeks prior to screening

    4. If the investigator is deemed unsuitable for the subject of this clinical trial due to other reasons

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital Seoul Seodaemun-gu Korea, Republic of 03722

    Sponsors and Collaborators

    • Jeil Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeil Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT06144788
    Other Study ID Numbers:
    • JP-2266-201
    First Posted:
    Nov 22, 2023
    Last Update Posted:
    Nov 22, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Sodium-Glucose Transporter 2 Inhibitors

    Study Results

    No Results Posted as of Nov 22, 2023